Trial Outcomes & Findings for Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile) (NCT NCT04446611)

Results Overview

Adverse birth outcomes as defined by the proportion of participants (pregnant women) with live birth who experienced preterm birth (born alive before 37 completed weeks of gestation) or low birth weight (less than 2500g) as recorded in the maternity case records

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2247 participants

Primary outcome timeframe

Recorded within 2 weeks of delivery

Results posted on

2026-07-17

Participant Flow

Study participants/population are pregnant women.

Pregnant women attending the first antenatal visit who met the eligibility criteria and provided informed consent.

Participant milestones

Participant milestones
Measure	Screen Once at 1st ANC + Test-of-Cure (Treatment 1) One-time diagnostic screening at first antenatal care \< 27 weeks gestation, plus test-of-cure three to five weeks post-treatment	Screen Twice at 1st ANC + 30-34 Gestation (Treatment 2) Repeated diagnostic screening at first antenatal care \< 27 weeks gestation, and 30-34 weeks gestation	Syndromic Management (Control) Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
Overall Study STARTED	754	738	755
Overall Study COMPLETED	703	706	710
Overall Study NOT COMPLETED	51	32	45

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Median age (in years) is used to report this continuous outcome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test at 1st ANC + Test-of-Cure (Treatment 1) n=754 Participants Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment	Test at 1st ANC + 30-34 Gestation (Treatment 2) n=738 Participants Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation	Syndromic Management (Control) n=755 Participants Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.	Total n=2247 Participants Total of all reporting groups
Age, Continuous	28 Years n=754 Participants • Median age (in years) is used to report this continuous outcome	28 Years n=738 Participants • Median age (in years) is used to report this continuous outcome	28 Years n=755 Participants • Median age (in years) is used to report this continuous outcome	28 Years n=2247 Participants • Median age (in years) is used to report this continuous outcome
Sex: Female, Male Female	754 Participants n=754 Participants	738 Participants n=738 Participants	755 Participants n=755 Participants	2247 Participants n=2247 Participants
Sex: Female, Male Male	0 Participants n=754 Participants	0 Participants n=738 Participants	0 Participants n=755 Participants	0 Participants n=2247 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Africa	754 Participants n=754 Participants	738 Participants n=738 Participants	755 Participants n=755 Participants	2247 Participants n=2247 Participants
STI Prevalence	193 Participants n=754 Participants	186 Participants n=738 Participants	218 Participants n=755 Participants	597 Participants n=2247 Participants

PRIMARY outcome

Timeframe: Recorded within 2 weeks of delivery

Population: Participants (pregnant women) with live births - The proportion of participants with live births) who experienced preterm birth or low birth weight. Calculated as number with adverse birth outcome (number)/total number who experienced a live birth delivery.

Adverse birth outcomes as defined by the proportion of participants (pregnant women) with live birth who experienced preterm birth (born alive before 37 completed weeks of gestation) or low birth weight (less than 2500g) as recorded in the maternity case records

Outcome measures

Outcome measures
Measure	Screen Once at 1st ANC + Test-of-Cure (Treatment 1) n=625 Participants One-time diagnostic STI screening at first antenatal care \< 27 weeks gestation, plus test-of-cure three to five weeks post-treatment	Screen Twice at 1st ANC + 30-34 Gestation (Treatment 2) n=642 Participants Repeated diagnostic screening at first antenatal care \< 27 weeks gestation, and 30-34 weeks gestation	Syndromic Management (Control) n=643 Participants Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
Frequency of Adverse Birth Outcomes Among Pregnant Women With a Live Birth Across Study Arms	143 Participants	132 Participants	149 Participants

SECONDARY outcome

Timeframe: Recorded within 2 weeks of delivery

Population: Participants with live births

The frequency of live births before 37 completed weeks of gestation (among pregnant women enrolled who had a live birth), as validated by ultrasound dating at first antenatal visit

Outcome measures

Outcome measures
Measure	Screen Once at 1st ANC + Test-of-Cure (Treatment 1) n=625 Participants One-time diagnostic STI screening at first antenatal care \< 27 weeks gestation, plus test-of-cure three to five weeks post-treatment	Screen Twice at 1st ANC + 30-34 Gestation (Treatment 2) n=642 Participants Repeated diagnostic screening at first antenatal care \< 27 weeks gestation, and 30-34 weeks gestation	Syndromic Management (Control) n=643 Participants Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
Incidence of Preterm Birth Among Study Arms Measured in Pregnant Women Who Had a Live Birth	118 Participants	93 Participants	121 Participants

SECONDARY outcome

Timeframe: Recorded within 2 weeks of delivery

Population: Participants with live births

The frequency of mothers with live births who delivered an infant with birth weight \< 2500g, as recorded in the maternity case records

Outcome measures

Outcome measures
Measure	Screen Once at 1st ANC + Test-of-Cure (Treatment 1) n=625 Participants One-time diagnostic STI screening at first antenatal care \< 27 weeks gestation, plus test-of-cure three to five weeks post-treatment	Screen Twice at 1st ANC + 30-34 Gestation (Treatment 2) n=642 Participants Repeated diagnostic screening at first antenatal care \< 27 weeks gestation, and 30-34 weeks gestation	Syndromic Management (Control) n=643 Participants Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
Incidence of Low Birthweight Among Study Arms Measured in Pregnant Women Who Had a Live Birth	88 Participants	83 Participants	82 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at follow up antenatal (30-34 weeks) and postnatal (within 2 weeks of expected delivery date) timepoints.

Population: Total number of participants for whom outcome data were retrieved before study closure. Due to the expiration of the funding period and subsequent administrative study closure, data collection was finalized only for participants who reached the 2-week post-delivery milestone by February 2025. Systematic follow-up was not attempted for the remaining 108 enrolled participants who had not yet reached this study endpoint at the time of closure.

Composite frequency of miscarriage (\<28 weeks' gestation) or stillbirth (\> 28 weeks' gestation) and the individual components, as indicated in the maternal case records

Outcome measures

Outcome measures
Measure	Screen Once at 1st ANC + Test-of-Cure (Treatment 1) n=703 Participants One-time diagnostic STI screening at first antenatal care \< 27 weeks gestation, plus test-of-cure three to five weeks post-treatment	Screen Twice at 1st ANC + 30-34 Gestation (Treatment 2) n=706 Participants Repeated diagnostic screening at first antenatal care \< 27 weeks gestation, and 30-34 weeks gestation	Syndromic Management (Control) n=710 Participants Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
Fetal Loss (Miscarriage or Stillbirth) Among Study Arms	73 Participants	58 Participants	60 Participants

Adverse Events

Test at 1st ANC + Test-of-Cure (Treatment 1)

Serious events: 47 serious events

Other events: 0 other events

Deaths: 0 deaths

Test at 1st ANC + 30-34 Gestation (Treatment 2)

Serious events: 38 serious events

Other events: 0 other events

Deaths: 1 deaths

Syndromic Management (Control)

Serious events: 46 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Test at 1st ANC + Test-of-Cure (Treatment 1) n=754 participants at risk Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment	Test at 1st ANC + 30-34 Gestation (Treatment 2) n=738 participants at risk Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation	Syndromic Management (Control) n=755 participants at risk Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.
Pregnancy, puerperium and perinatal conditions Antepartum or postpartum Hemorrhage	1.2% 9/754 • From enrollment through 2 weeks post-delivery	1.1% 8/738 • From enrollment through 2 weeks post-delivery	1.7% 13/755 • From enrollment through 2 weeks post-delivery
Pregnancy, puerperium and perinatal conditions Preeclampsia or Eclampsia	1.5% 11/754 • From enrollment through 2 weeks post-delivery	1.4% 10/738 • From enrollment through 2 weeks post-delivery	0.79% 6/755 • From enrollment through 2 weeks post-delivery
Pregnancy, puerperium and perinatal conditions Uterine rupture	0.13% 1/754 • From enrollment through 2 weeks post-delivery	0.14% 1/738 • From enrollment through 2 weeks post-delivery	0.26% 2/755 • From enrollment through 2 weeks post-delivery
Pregnancy, puerperium and perinatal conditions Sepsis	0.27% 2/754 • From enrollment through 2 weeks post-delivery	0.14% 1/738 • From enrollment through 2 weeks post-delivery	0.00% 0/755 • From enrollment through 2 weeks post-delivery
Pregnancy, puerperium and perinatal conditions Retained placenta	0.93% 7/754 • From enrollment through 2 weeks post-delivery	0.14% 1/738 • From enrollment through 2 weeks post-delivery	0.93% 7/755 • From enrollment through 2 weeks post-delivery
Pregnancy, puerperium and perinatal conditions Prolonged rupture of membranes	0.53% 4/754 • From enrollment through 2 weeks post-delivery	0.68% 5/738 • From enrollment through 2 weeks post-delivery	0.66% 5/755 • From enrollment through 2 weeks post-delivery
Pregnancy, puerperium and perinatal conditions Obstructed labor	1.7% 13/754 • From enrollment through 2 weeks post-delivery	1.6% 12/738 • From enrollment through 2 weeks post-delivery	1.7% 13/755 • From enrollment through 2 weeks post-delivery

Other adverse events

Adverse event data not reported

Additional Information

Philani Ndiphile Scientific Lead, USC

University of Southern California (USC)

Phone: 3234430000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place