Trial Outcomes & Findings for Does Fish Oil Prevent Depression in Pregnancy and Postpartum? (NCT NCT00711971)
NCT ID: NCT00711971
Last Updated: 2017-04-28
Results Overview
The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
126 participants
Primary outcome timeframe
6 - 8 weeks postpartum
Results posted on
2017-04-28
Participant Flow
Participant milestones
| Measure |
EPA-rich Fish Oil Supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
Soy oil placebo: control arm
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
42
|
|
Overall Study
COMPLETED
|
39
|
38
|
41
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
1
|
Reasons for withdrawal
| Measure |
EPA-rich Fish Oil Supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
Soy oil placebo: control arm
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
1
|
Baseline Characteristics
Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
Baseline characteristics by cohort
| Measure |
EPA-rich Fish Oil Supplement
n=39 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=38 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=41 Participants
placebo: control arm
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 5.0 • n=99 Participants
|
30.6 years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
30.4 years
STANDARD_DEVIATION 5.9 • n=206 Participants
|
30.3 years
STANDARD_DEVIATION 5.18 • n=7 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
African-American
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Hispanic-Latina
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific ethnicity
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
39 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
118 Participants
n=7 Participants
|
|
Gestational age at enrollment
|
15.9 weeks
STANDARD_DEVIATION 2.6 • n=99 Participants
|
17 weeks
STANDARD_DEVIATION 2.3 • n=107 Participants
|
16.2 weeks
STANDARD_DEVIATION 2.3 • n=206 Participants
|
16.36 weeks
STANDARD_DEVIATION 2.4 • n=7 Participants
|
|
Parity
|
0.87 number of previous deliveries
STANDARD_DEVIATION 0.83 • n=99 Participants
|
1.08 number of previous deliveries
STANDARD_DEVIATION 0.94 • n=107 Participants
|
0.85 number of previous deliveries
STANDARD_DEVIATION 1.20 • n=206 Participants
|
0.93 number of previous deliveries
STANDARD_DEVIATION 1.01 • n=7 Participants
|
|
Past history of depression(self reported)
|
32 participants
n=99 Participants
|
30 participants
n=107 Participants
|
33 participants
n=206 Participants
|
95 participants
n=7 Participants
|
|
BDI (Beck Depression Inventory) score
|
8.41 units on a scale
STANDARD_DEVIATION 5.65 • n=99 Participants
|
7.79 units on a scale
STANDARD_DEVIATION 5.29 • n=107 Participants
|
7.15 units on a scale
STANDARD_DEVIATION 5.21 • n=206 Participants
|
7.72 units on a scale
STANDARD_DEVIATION 5.38 • n=7 Participants
|
|
EPDS Screen (Edinburgh Prenatal Depression Scale)
|
7.93 units on a scale
STANDARD_DEVIATION 4.63 • n=99 Participants
|
7.56 units on a scale
STANDARD_DEVIATION 4.49 • n=107 Participants
|
7.34 units on a scale
STANDARD_DEVIATION 4.40 • n=206 Participants
|
7.80 units on a scale
STANDARD_DEVIATION 4.51 • n=7 Participants
|
PRIMARY outcome
Timeframe: 6 - 8 weeks postpartumPopulation: Per protocol analysis is reported here.
The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.)
Outcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=31 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=33 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=32 Participants
placebo: control arm
|
|---|---|---|---|
|
Beck Depression Inventory
BDI at 24-28 weeks' gestation
|
7.9 units on a scale
Standard Deviation 3.7
|
6.5 units on a scale
Standard Deviation 4.7
|
6.3 units on a scale
Standard Deviation 4.1
|
|
Beck Depression Inventory
BDI at 34-36 weeks' gestation
|
7.4 units on a scale
Standard Deviation 5.0
|
5.9 units on a scale
Standard Deviation 4.9
|
7.2 units on a scale
Standard Deviation 5.2
|
|
Beck Depression Inventory
BDI at 6-8 weeks postpartum
|
6.6 units on a scale
Standard Deviation 5.2
|
5.1 units on a scale
Standard Deviation 4.4
|
6.2 units on a scale
Standard Deviation 6.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after deliveryPopulation: Gestational hypertension and diabetes were self-reported for all participants so her data is included for those two rows. One woman in the soy placebo arm delivered out of the geographic area, so documentation of delivery outcome is unavailable for analysis.
While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery.
Outcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=39 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=38 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=41 Participants
placebo: control arm
|
|---|---|---|---|
|
Maternal Outcomes
Gestational Hypertension or Preeclampsia
|
8 participants
|
2 participants
|
5 participants
|
|
Maternal Outcomes
Gestational Diabetes Mellitus
|
7 participants
|
1 participants
|
2 participants
|
|
Maternal Outcomes
Induced Labor
|
15 participants
|
12 participants
|
8 participants
|
|
Maternal Outcomes
Cesarean Section
|
10 participants
|
12 participants
|
11 participants
|
|
Maternal Outcomes
Spontaneous Vaginal Delivery
|
25 participants
|
25 participants
|
28 participants
|
|
Maternal Outcomes
Operative Vaginal Delivery
|
4 participants
|
1 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: delivery date was assessed by medical record review between 1 day and 8 weeks after deliveryPopulation: Gestational age is measured based on the pregnancy not the neonates, therefore although there were 40 babies born to the 39 mothers randomized to the EPA-rich fish oil, it is proper to consider the participants analyzed to be the 39 participating mothers. This is clarified still further by identifying the units appropriately as pregnancies.
Outcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=39 pregnancies
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=38 pregnancies
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=41 pregnancies
placebo: control arm
|
|---|---|---|---|
|
Gestational Age at Delivery (Weeks)
|
39.1 weeks
Standard Deviation 1.5
|
40.4 weeks
Standard Deviation 0.9
|
39.1 weeks
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 24 hours after deliveryOutcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=39 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=38 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=41 Participants
placebo: control arm
|
|---|---|---|---|
|
Estimated Blood Loss (ml)
|
507 mL
Standard Deviation 481
|
508 mL
Standard Deviation 325
|
454 mL
Standard Deviation 296
|
OTHER_PRE_SPECIFIED outcome
Timeframe: immediately after birthPopulation: Data is provided for all babies on whom delivery weights were available with a set of twins in EPA rich fish oil arm and a delivery elsewhere for whom no birth weight was available for one baby from a mother in the Soy oil placebo arm. Thus there is 1 more participant than mothers participating in the EPA-rich arm and one less in the soy oil arm.
Mean weight in grams: where \<2500 gm is considered small for gestational age and \>4500 gm is considered large for gestational age.
Outcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=40 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=38 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=40 Participants
placebo: control arm
|
|---|---|---|---|
|
Neonatal Birthweight
|
3402 grams
Standard Deviation 550
|
3774 grams
Standard Deviation 438
|
3309 grams
Standard Deviation 555
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks post deliveryPopulation: One set of twins in group A
Admission to the NICU
Outcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=40 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=38 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=40 Participants
placebo: control arm
|
|---|---|---|---|
|
NICU (Neonatal Intensive Care Unit) Admissions
|
6 Participants
|
2 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 minute after birthPopulation: One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.
Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the one minute Apgar.
Outcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=40 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=38 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=40 Participants
placebo: control arm
|
|---|---|---|---|
|
One Minute Apgar Score
|
7.3 units on a scale
Standard Deviation 2.2
|
7.9 units on a scale
Standard Deviation 1.8
|
7.9 units on a scale
Standard Deviation 1.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 minutes after birthPopulation: One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available.
Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the five minute Apgar.
Outcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=40 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=38 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=40 Participants
placebo: control arm
|
|---|---|---|---|
|
Five Minute Apgar Score
|
8.6 units on a scale
Standard Deviation 0.8
|
9.1 units on a scale
Standard Deviation 0.2
|
8.9 units on a scale
Standard Deviation 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Immediately after birth (collected within the first hour after delivery)Population: Umbilical cord gases (pH) were sent at the discretion of the delivering physician and so were not available for all participants.
Arterial blood gas analysis of umbilical cord blood
Outcome measures
| Measure |
EPA-rich Fish Oil Supplement
n=34 Participants
EPA-rich fish oil supplement
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=31 Participants
DHA-rich fish oil supplement
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=31 Participants
placebo: control arm
|
|---|---|---|---|
|
Cord Arterial pH
|
7.26 pH
Standard Deviation 0.09
|
7.27 pH
Standard Deviation 0.05
|
7.27 pH
Standard Deviation 0.06
|
Adverse Events
EPA-rich Fish Oil Supplement
Serious events: 8 serious events
Other events: 28 other events
Deaths: 0 deaths
DHA-rich Fish Oil Supplement
Serious events: 5 serious events
Other events: 23 other events
Deaths: 0 deaths
Soy Oil Placebo
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EPA-rich Fish Oil Supplement
n=42 participants at risk
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=42 participants at risk
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=42 participants at risk
Soy oil placebo: control arm
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Premature Delivery
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
2.4%
1/42 • Number of events 1 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Pregnancy, puerperium and perinatal conditions
late miscarriage
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
2.4%
1/42 • Number of events 1 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
2.4%
1/42 • Number of events 1 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal ICU Admission
|
15.0%
6/40 • Number of events 6 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
5.3%
2/38 • Number of events 2 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
9.8%
4/41 • Number of events 4 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum hemorrhage
|
4.8%
2/42 • Number of events 2 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
7.1%
3/42 • Number of events 3 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Pregnancy, puerperium and perinatal conditions
Maternal ICU admission
|
2.4%
1/42 • Number of events 1 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
Other adverse events
| Measure |
EPA-rich Fish Oil Supplement
n=42 participants at risk
EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA
|
DHA-rich Fish Oil Supplement
n=42 participants at risk
DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA
|
Soy Oil Placebo
n=42 participants at risk
Soy oil placebo: control arm
|
|---|---|---|---|
|
Gastrointestinal disorders
Aftertaste
|
16.7%
7/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
19.0%
8/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
16.7%
7/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Gastrointestinal disorders
Belching
|
26.2%
11/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
33.3%
14/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
28.6%
12/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Endocrine disorders
Gestational Diabetes
|
11.9%
5/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
2.4%
1/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Blood and lymphatic system disorders
Infant Jaundice
|
22.5%
9/40 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
7.9%
3/38 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
4.9%
2/41 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Gastrointestinal disorders
Loose stools
|
11.9%
5/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
4.8%
2/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
11.9%
5/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Reproductive system and breast disorders
mastitis
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
9.5%
4/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Gastrointestinal disorders
nausea
|
9.5%
4/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
2.4%
1/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
4.8%
2/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Reproductive system and breast disorders
Preterm Contractions
|
9.5%
4/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
9.5%
4/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
2.4%
1/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
|
Gastrointestinal disorders
Heartburn
|
7.1%
3/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
0.00%
0/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
2.4%
1/42 • Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
|
Additional Information
Ellen Mozurkewich, Adjunct Assistant Professor
University of Michigan
Phone: (734) 546-2772
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place