Trial Outcomes & Findings for A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (NCT NCT02518594)

NCT ID: NCT02518594

Last Updated: 2026-03-10

Results Overview

Number of Participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1311 participants

Primary outcome timeframe

From randomization to 35 weeks gestation (a period of up to 19 weeks)

Results posted on

2026-03-10

Participant Flow

We conducted the trial at 16 centers. Mothers with twin gestations were enrolled in pregnancy and their offspring followed to discharge or 28 days after expected date of delivery. Infants were enrolled but not consented. The recruitment period was Nov 2015 - Oct 2024 and 437 women were randomized out of the planned sample size of 630.

Participant milestones

Participant milestones
Measure	Progesterone 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo placebo softgel capsule, daily from randomization to \< 35 wks	Progesterone - Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the 200mg micronized vaginal progesterone group	Arabin Pessary - Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the Arabin Pessary group	Placebo - Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the Placebo group
Overall Study STARTED	147	153	137	294	306	274
Overall Study COMPLETED	146	152	136	292	304	272
Overall Study NOT COMPLETED	1	1	1	2	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Progesterone 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo placebo softgel capsule, daily from randomization to \< 35 wks	Progesterone - Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the 200mg micronized vaginal progesterone group	Arabin Pessary - Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the Arabin Pessary group	Placebo - Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the Placebo group
Overall Study Lost to Follow-up	1	1	1	2	2	2

Baseline Characteristics

Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arabin Pessary-Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the Arabin Pessary group	Placebo-Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the Placebo group	Total n=437 Participants Total of all reporting groups	Progesterone n=147 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=153 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=137 Participants placebo softgel capsule, daily from randomization to \< 35 wks	Progesterone-Fetus/Neonates/Infants Fetus/Neonates/Infants of participants in the 200mg micronized vaginal progesterone group
Race/Ethnicity, Customized More than 1 Race	—	—	5 Participants n=437 Participants	1 Participants n=147 Participants	2 Participants n=153 Participants	2 Participants n=137 Participants	—
Age, Continuous	—	—	29.6 years STANDARD_DEVIATION 5.8 • n=437 Participants	29.3 years STANDARD_DEVIATION 6.4 • n=147 Participants	29.9 years STANDARD_DEVIATION 5.1 • n=153 Participants	29.7 years STANDARD_DEVIATION 5.7 • n=137 Participants	—
Sex: Female, Male Female	—	—	437 Participants n=437 Participants	147 Participants n=147 Participants	153 Participants n=153 Participants	137 Participants n=137 Participants	—
Sex: Female, Male Male	—	—	0 Participants n=437 Participants	0 Participants n=147 Participants	0 Participants n=153 Participants	0 Participants n=137 Participants	—
Race/Ethnicity, Customized American Indian or Alaska Native	—	—	0 Participants n=437 Participants	0 Participants n=147 Participants	0 Participants n=153 Participants	0 Participants n=137 Participants	—
Race/Ethnicity, Customized Asian	—	—	13 Participants n=437 Participants	3 Participants n=147 Participants	4 Participants n=153 Participants	6 Participants n=137 Participants	—
Race/Ethnicity, Customized Non-Hispanic Black	—	—	177 Participants n=437 Participants	61 Participants n=147 Participants	67 Participants n=153 Participants	49 Participants n=137 Participants	—
Race/Ethnicity, Customized Hispanic	—	—	85 Participants n=437 Participants	30 Participants n=147 Participants	29 Participants n=153 Participants	26 Participants n=137 Participants	—
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	—	—	0 Participants n=437 Participants	0 Participants n=147 Participants	0 Participants n=153 Participants	0 Participants n=137 Participants	—
Race/Ethnicity, Customized Non-Hispanic White	—	—	152 Participants n=437 Participants	51 Participants n=147 Participants	49 Participants n=153 Participants	52 Participants n=137 Participants	—
Race/Ethnicity, Customized Not reported or Unknown	—	—	5 Participants n=437 Participants	1 Participants n=147 Participants	2 Participants n=153 Participants	2 Participants n=137 Participants	—
Body mass index at first clinic visit	—	—	28.1 kilograms per meter squared n=430 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	28.0 kilograms per meter squared n=145 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	27.0 kilograms per meter squared n=150 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	29.2 kilograms per meter squared n=135 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	—
Number of participants by body mass index at first clinic visit (categorical) BMI <30 kg/m^2	—	—	256 Participants n=430 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	87 Participants n=145 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	95 Participants n=150 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	74 Participants n=135 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	—
Number of participants by body mass index at first clinic visit (categorical) BMI 30-34.9 kg/m^2	—	—	87 Participants n=430 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	34 Participants n=145 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	26 Participants n=150 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	27 Participants n=135 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	—
Number of participants by body mass index at first clinic visit (categorical) BMI <35-39.9 kg/m^2	—	—	42 Participants n=430 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	11 Participants n=145 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	13 Participants n=150 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	18 Participants n=135 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	—
Number of participants by body mass index at first clinic visit (categorical) BMI >=40 kg/m^2	—	—	45 Participants n=430 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	13 Participants n=145 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	16 Participants n=150 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	16 Participants n=135 Participants • Data unavailable for 2 participants in the progesterone group, 2 participants in the placebo group, and 3 participants in the pessary group.	—
Number of participants reporting cigarette use during pregnancy	—	—	37 Participants n=437 Participants	8 Participants n=147 Participants	15 Participants n=153 Participants	14 Participants n=137 Participants	—
Number of participants reporting alcohol use during pregnancy	—	—	15 Participants n=437 Participants	5 Participants n=147 Participants	8 Participants n=153 Participants	2 Participants n=137 Participants	—
Number of participants married or living with partner	—	—	287 Participants n=437 Participants	93 Participants n=147 Participants	104 Participants n=153 Participants	90 Participants n=137 Participants	—
Number of participants employed full- or part-time	—	—	280 Participants n=437 Participants	93 Participants n=147 Participants	98 Participants n=153 Participants	89 Participants n=137 Participants	—
Number of participants reporting more than 12 years of education	—	—	283 Participants n=436 Participants • Data was missing for one participant in the placebo group.	90 Participants n=147 Participants • Data was missing for one participant in the placebo group.	102 Participants n=153 Participants • Data was missing for one participant in the placebo group.	91 Participants n=136 Participants • Data was missing for one participant in the placebo group.	—
Number of participants by type of insurance Private	—	—	237 Participants n=437 Participants	79 Participants n=147 Participants	83 Participants n=153 Participants	75 Participants n=137 Participants	—
Number of participants by type of insurance Government	—	—	194 Participants n=437 Participants	67 Participants n=147 Participants	68 Participants n=153 Participants	59 Participants n=137 Participants	—
Number of participants by type of insurance Self-Pay	—	—	6 Participants n=437 Participants	1 Participants n=147 Participants	2 Participants n=153 Participants	3 Participants n=137 Participants	—
Number of participants with prior cervical surgery	—	—	39 Participants n=437 Participants	12 Participants n=147 Participants	16 Participants n=153 Participants	11 Participants n=137 Participants	—
Number of nulliparous participants	—	—	232 Participants n=437 Participants	80 Participants n=147 Participants	74 Participants n=153 Participants	78 Participants n=137 Participants	—
Number of participants with any prior preterm deliveries	—	—	60 Participants n=437 Participants	21 Participants n=147 Participants	23 Participants n=153 Participants	16 Participants n=137 Participants	—
Number of participants by type of pregnancy Spontaneous	—	—	344 Participants n=437 Participants	116 Participants n=147 Participants	125 Participants n=153 Participants	103 Participants n=137 Participants	—
Number of participants by type of pregnancy In Vitro Fertilization	—	—	64 Participants n=437 Participants	21 Participants n=147 Participants	24 Participants n=153 Participants	19 Participants n=137 Participants	—
Number of participants by type of pregnancy Ovulation induction / artificial insemination	—	—	29 Participants n=437 Participants	10 Participants n=147 Participants	4 Participants n=153 Participants	15 Participants n=137 Participants	—
Number of participants by chorionicity Monochorionic	—	—	96 Participants n=436 Participants • Data is missing for one participant in the Pessary group.	33 Participants n=147 Participants • Data is missing for one participant in the Pessary group.	35 Participants n=152 Participants • Data is missing for one participant in the Pessary group.	28 Participants n=137 Participants • Data is missing for one participant in the Pessary group.	—
Number of participants by chorionicity Dichorionic	—	—	340 Participants n=436 Participants • Data is missing for one participant in the Pessary group.	114 Participants n=147 Participants • Data is missing for one participant in the Pessary group.	117 Participants n=152 Participants • Data is missing for one participant in the Pessary group.	109 Participants n=137 Participants • Data is missing for one participant in the Pessary group.	—
Number of participants with vaginal infection prior to enrollment, No. (%)	—	—	83 Participants n=437 Participants	23 Participants n=147 Participants	35 Participants n=153 Participants	25 Participants n=137 Participants	—
Cervical length at screening	—	—	20.7 millimeters n=437 Participants	21.9 millimeters n=147 Participants	19.2 millimeters n=153 Participants	20.7 millimeters n=137 Participants	—
Number of participants with cervical length at screening <15mm	—	—	120 Participants n=437 Participants	31 Participants n=147 Participants	44 Participants n=153 Participants	45 Participants n=137 Participants	—
Number of participants with cervical length at screening <20mm	—	—	202 Participants n=437 Participants	59 Participants n=147 Participants	82 Participants n=153 Participants	61 Participants n=137 Participants	—
Number of participants with amniotic cavity debris on screening ultrasound	—	—	33 Participants n=436 Participants • Data was missing for a participant in the placebo group.	12 Participants n=147 Participants • Data was missing for a participant in the placebo group.	11 Participants n=153 Participants • Data was missing for a participant in the placebo group.	10 Participants n=136 Participants • Data was missing for a participant in the placebo group.	—
Number of participants with funneling on screening ultrasound	—	—	154 Participants n=437 Participants	41 Participants n=147 Participants	62 Participants n=153 Participants	51 Participants n=137 Participants	—
Gestation at enrollment	—	—	21.6 weeks n=437 Participants	21.6 weeks n=147 Participants	21.6 weeks n=153 Participants	21.7 weeks n=137 Participants	—
Days from screening to randomization	—	—	1 days n=437 Participants	1 days n=147 Participants	0 days n=153 Participants	1 days n=137 Participants	—

PRIMARY outcome

Timeframe: From randomization to 35 weeks gestation (a period of up to 19 weeks)

Number of Participants who had preterm delivery or fetal loss of either twin prior to 35 weeks gestation

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Participants With Delivery or Fetal Loss of Either Twin Prior to 35 Weeks Gestation	84 Participants	84 Participants	86 Participants

SECONDARY outcome

Timeframe: Randomization to delivery (a period of up to 26 weeks)

Days from the time of randomization (16-23 weeks gestation) to delivery or death of the fetus.

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Days From Randomization to Delivery (or Fetal Demise)	86 days Interval 53.0 to 106.0	86 days Interval 53.0 to 106.0	77 days Interval 51.0 to 101.0

SECONDARY outcome

Timeframe: Randomization to delivery (a period of up to 26 weeks)

Gestational age at the time of delivery or death

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Gestational Age at Delivery or Fetal Death	34.1 weeks Interval 29.0 to 36.1	33.9 weeks Interval 28.9 to 36.6	33.1 weeks Interval 27.9 to 36.2

SECONDARY outcome

Timeframe: From randomization to up to 28 weeks gestation (a period if up to 12 weeks)

Preterm delivery or fetal loss of either twin prior to 28 weeks gestation

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 28 Weeks Gestation	33 Participants	34 Participants	34 Participants

SECONDARY outcome

Timeframe: From randomization to 32 weeks gestation (a period of up to 16 weeks)

Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 32 Weeks Gestation	59 Participants	52 Participants	58 Participants

SECONDARY outcome

Timeframe: randomization to 37 weeks gestation (a period of up to 21 weeks)

Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Participants With Preterm Delivery or Fetal Demise of Either Twin Prior to 37 Weeks Gestation	124 Participants	123 Participants	115 Participants

SECONDARY outcome

Timeframe: randomization to 32 weeks gestation (a period of up to 16 weeks)

Spontaneous preterm delivery (following preterm labor or pPROM) before 32 weeks gestation

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Participants With Spontaneous Preterm Delivery < 32 Weeks Gestation	51 Participants	45 Participants	53 Participants

SECONDARY outcome

Timeframe: randomization to 35 weeks gestation (a period of up to 19 weeks)

Spontaneous preterm delivery (following preterm labor or pPROM) before 35 weeks gestation

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Participants With Spontaneous Preterm Delivery < 35 Weeks Gestation	69 Participants	65 Participants	72 Participants

SECONDARY outcome

Timeframe: randomization to 35 weeks gestation (a period of up to 19 weeks)

Preterm delivery prior to 35 weeks gestation with medical indications

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Participants With Indicated Preterm Delivery for < 35 Weeks	15 Participants	18 Participants	14 Participants

SECONDARY outcome

Timeframe: Randomization to delivery (a period of up to 26 weeks)

Delivery by cesarean

Outcome measures

Outcome measures
Measure	Progesterone n=146 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=136 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Participants With Cesarean Delivery	96 Participants	95 Participants	84 Participants

SECONDARY outcome

Timeframe: From randomization to up to 28 days post birth (a period of up to 30 weeks)

Population: Among all fetuses (twins). One participant was lost to follow-up in each group (therefore one set of twins was lost to follow-up in each group). Data was missing for one set of twins in the placebo group.

Number of fetal, neonatal or infant deaths

Outcome measures

Outcome measures
Measure	Progesterone n=292 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=304 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=270 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Fetal, Neonatal or Infant Deaths	30 Participants	32 Participants	40 Participants

SECONDARY outcome

Timeframe: randomization to delivery (a period of up to 26 weeks)

Population: Among live birth deliveries (excludes fetal deaths). Data is missing for two neonates in the Progesterone group.

The number of neonates whose birthweight compared with gestational age at delivery was less than the 5th percentile, as assessed by sex and race, using United States birth certificate data.

Outcome measures

Outcome measures
Measure	Progesterone n=278 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=292 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=255 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Neonates Small for Gestational Age < 5th Percentile	27 Participants	16 Participants	27 Participants

SECONDARY outcome

Timeframe: Birth to neonatal discharge or death, whichever is first (up to 70 weeks)

Population: Among all fetuses (twins).

The number of neonates diagnosed with any one of fetal or neonatal death or Respiratory Distress Syndrome, Grade 3 or 4 Intraventricular Hemorrhage, Periventricular Leukomalacia, Stage 2 or 3 Necrotizing Enterocolitis, Bronchopulmonary Dysplasia, Stage III or higher Retinopathy of Prematurity, or early onset sepsis. IVH grades III or IV are as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papile classification system. The number of neonates diagnosed with NEC, defined as modified Bell Stage 2 or 3 where stage 2 represents clinical signs and symptoms with pneumatosis intestinalis on radiographs and stage 3 is defined as advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation. The stages of Retinopathy of Prematurity range from 1 (mild) to 5 (severe).

Outcome measures

Outcome measures
Measure	Progesterone n=292 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=304 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=270 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Neonates With the Composite Neonatal Outcome	124 Participants	126 Participants	114 Participants

SECONDARY outcome

Timeframe: Birth to the time of NICU or Intermediate Care Admission, whichever came first (a maximum of 10 days)

Population: Among live births (excludes fetal deaths).

The number of neonates admitted to intensive care (NICU) or intermediate care out of all liveborn infants.

Outcome measures

Outcome measures
Measure	Progesterone n=280 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=292 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=255 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Number of Neonates Admitted to Intensive Care (NICU) or Intermediate Care	197 Participants	178 Participants	185 Participants

SECONDARY outcome

Timeframe: admission to hospital discharge (a median of 12 days with a maximum of 490 days)

Population: among live birth deliveries (excludes fetal deaths); data was missing for 3 neonates in the progesterone group, 2 neonates in the pessary group and 1 neonate in the placebo group.

Number of days the neonate was in the hospital

Outcome measures

Outcome measures
Measure	Progesterone n=277 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=290 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=254 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Length of Neonatal Hospital Stay in Days	11 days Interval 3.0 to 37.0	11 days Interval 3.0 to 37.0	14 days Interval 3.0 to 42.0

SECONDARY outcome

Timeframe: admission to discharge from NICU or intermediate care (a median of 28 days, with a maximum of 491 days)

Population: Data is among neonates admitted to the NICU. Data was missing for 3 neonates in the progesterone group, 2 neonates in the pessary group, and 1 neonate in the placebo group.

Length of stay in neonatal intensive care (NICU) or intermediate care

Outcome measures

Outcome measures
Measure	Progesterone n=194 Participants 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=176 Participants placement and management of an Arabin Pessary from randomization to \< 35 wks	Placebo n=184 Participants placebo softgel capsule, daily from randomization to \< 35 wks
Length of Stay in Neonatal Intensive Care (NICU) or Intermediate Care in Days	24 days Interval 11.0 to 57.0	29 days Interval 15.0 to 63.0	30 days Interval 12.0 to 55.0

Adverse Events

Progesterone

Serious events: 10 serious events

Other events: 125 other events

Deaths: 0 deaths

Arabin Pessary

Serious events: 6 serious events

Other events: 129 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 113 other events

Deaths: 0 deaths

Progesterone - Infants

Serious events: 37 serious events

Other events: 0 other events

Deaths: 30 deaths

Arabin Pessary - Infants

Serious events: 43 serious events

Other events: 0 other events

Deaths: 32 deaths

Placebo - Infants

Serious events: 52 serious events

Other events: 0 other events

Deaths: 40 deaths

Serious adverse events

Serious adverse events
Measure	Progesterone n=146 participants at risk；n=147 participants at risk 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 participants at risk；n=153 participants at risk Arabin Pessary: Placement management from randomization to \< 35 wks	Placebo n=136 participants at risk；n=137 participants at risk placebo softgel capsule, daily from randomization to \< 35 wks	Progesterone - Infants n=294 participants at risk Infants of participants in the Progesterone group (200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks)	Arabin Pessary - Infants n=306 participants at risk Infants of participants in the Arabin Pessary group (Placement management from randomization to \< 35 wks)	Placebo - Infants n=274 participants at risk Infants of participants in the Placebo group ( placebo softgel capsule, daily from randomization to \< 35 wks)
Blood and lymphatic system disorders Anemia requiring transfusion	0.68% 1/147 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.73% 1/137 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Blood and lymphatic system disorders Postpartum hemorrhage	1.4% 2/147 • Number of events 2 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	2.6% 4/153 • Number of events 4 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.73% 1/137 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Dyspnea	0.68% 1/147 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Bilateral pleural effusions	0.68% 1/147 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Seizure	0.68% 1/147 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Trauma	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.65% 1/153 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.73% 1/137 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations Bronchitis with asthma	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.73% 1/137 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations Postpartum fever, postpartum hemorrhage	0.68% 1/147 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations Recurrent postpartum fever secondary endometritis	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.73% 1/137 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Gastrointestinal disorders Nausea and vomiting	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.73% 1/137 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Cardiac disorders Postpartum cardiomyopathy	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.65% 1/153 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	2.0% 3/147 • Number of events 3 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.65% 1/153 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.73% 1/137 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Skin and subcutaneous tissue disorders Wound cellulitis	0.68% 1/147 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Hepatobiliary disorders Ascites	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.36% 1/274 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Gastrointestinal disorders Bowel obstruction	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.34% 1/294 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Musculoskeletal and connective tissue disorders Craniosynostosis of the sagittal suture line	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.33% 1/306 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Musculoskeletal and connective tissue disorders Pulmonic stenosis	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.68% 2/294 • Number of events 2 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Fetal death	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	4.1% 12/294 • Number of events 12 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	3.9% 12/306 • Number of events 12 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	5.5% 15/274 • Number of events 15 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Neonatal/infant death	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	6.1% 18/294 • Number of events 18 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	6.5% 20/306 • Number of events 20 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	9.1% 25/274 • Number of events 25 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Hypothermia and sepsis	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.34% 1/294 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Physical anomaly	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	1.0% 3/294 • Number of events 3 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	2.0% 6/306 • Number of events 6 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.36% 1/274 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Renal and urinary disorders Hydronephrosis	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.33% 1/306 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Renal and urinary disorders Multi-cystic dysplastic kidney	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.33% 1/306 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/274 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Blood and lymphatic system disorders Jaundice	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.36% 1/274 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Blood and lymphatic system disorders NEC/sepsis or bacteremia	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.65% 2/306 • Number of events 2 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.36% 1/274 • Number of events 1 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations RSV bronchiolitis	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	1.1% 3/274 • Number of events 3 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations Severe respiratory acidosis/RSV/sepsis	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.73% 2/274 • Number of events 2 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Cardiac disorders Ventricular septal defect	0.00% 0/147 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/153 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/137 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/294 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	0.00% 0/306 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	1.1% 3/274 • Number of events 3 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.

Other adverse events

Other adverse events
Measure	Progesterone n=146 participants at risk；n=147 participants at risk 200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks	Arabin Pessary n=152 participants at risk；n=153 participants at risk Arabin Pessary: Placement management from randomization to \< 35 wks	Placebo n=136 participants at risk；n=137 participants at risk placebo softgel capsule, daily from randomization to \< 35 wks	Progesterone - Infants n=294 participants at risk Infants of participants in the Progesterone group (200mg micronized vaginal progesterone softgel capsule, daily from randomization to \< 35 wks)	Arabin Pessary - Infants n=306 participants at risk Infants of participants in the Arabin Pessary group (Placement management from randomization to \< 35 wks)	Placebo - Infants n=274 participants at risk Infants of participants in the Placebo group ( placebo softgel capsule, daily from randomization to \< 35 wks)
Reproductive system and breast disorders Vaginal soreness/discomfort	20.5% 30/146 • Number of events 30 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	37.5% 57/152 • Number of events 57 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	23.5% 32/136 • Number of events 32 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations Vaginal discharge	73.3% 107/146 • Number of events 107 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	75.0% 114/152 • Number of events 114 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	71.3% 97/136 • Number of events 97 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations Vaginal itching	18.5% 27/146 • Number of events 27 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	13.2% 20/152 • Number of events 20 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	23.5% 32/136 • Number of events 32 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations Vaginal burning	8.2% 12/146 • Number of events 12 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	9.9% 15/152 • Number of events 15 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	11.0% 15/136 • Number of events 15 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Infections and infestations Vaginal odor	15.1% 22/146 • Number of events 22 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	20.4% 31/152 • Number of events 31 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	7.4% 10/136 • Number of events 10 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Lower abdominal or pelvic pressure	30.8% 45/146 • Number of events 45 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	31.6% 48/152 • Number of events 48 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	29.4% 40/136 • Number of events 40 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
General disorders Lower abdominal or pelvic pain	20.5% 30/146 • Number of events 30 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	23.7% 36/152 • Number of events 36 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	22.8% 31/136 • Number of events 31 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.
Renal and urinary disorders Incontinence or change in urinary frequency	12.3% 18/146 • Number of events 18 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	16.4% 25/152 • Number of events 25 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	11.8% 16/136 • Number of events 16 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.	— 0/0 • Adverse Events were assessed in mothers/fetuses from randomization to 28 days past the project due date (approximately up to 28 weeks) and in infants from birth through neonatal discharge, up to 70 weeks. Adverse events were collected for maternal participants and their fetuses/neonates. Other (not including serious) adverse events were not collected for the three participants (one in each group) lost to follow-up, nor were they collected for neonates/infants. Two mothers had more than one serious adverse event.

Additional Information

Joseph Biggio, MD, MS

Ochsner Health

Phone: 504 842 5574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place