Active — Not RecruitingNot Applicable

Zambian Preterm Birth Prevention Study

Zambia9,000 participantsStarted 2015-08

Plain-language summary

This prospective non-intervention cohort study will enroll women in the first or early second trimester of pregnancy and follow them through delivery (or end of pregnancy) and 1 year postpartum. Infants will also be followed until 1 year postpartum. Detailed medical and obstetrical information will be collected, as well as biological samples, in order to better elucidate the biological mechanisms leading to preterm delivery among Zambian women, in an effort to identify new strategies for prevention.

Who can participate

Age range15 Years – 49 Years

SexFEMALE

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Inclusion criteria

✓. Have a completed screening ultrasound with gestational age \< 20 weeks
✓. Be HIV-uninfected at enrollment (NB: prior to Protocol Version 4.0 \[3 Nov 2017\] enrolled both HIV-infected and uninfected women)
✓. Have a singleton or twin pregnancy with fetal heart tones confirmed by ultrasound
✓. Reside within Lusaka with no plans to relocate during the study follow-up period
✓. Be willing to provide written, informed consent
✓. Be willing to allow their infants to participate in the study

Exclusion criteria

✕. Pregnant women \> 24 weeks' gestation or with screening ultrasound ≥ 16 weeks
✕. Infants born to women not enrolled in the study

What they're measuring

Preterm Birth <37

Timeframe: Measured at delivery

Trial details

NCT IDNCT02738892

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-05

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