Study on preventing preterm birth in Zambian women
Preventing Preterm Birth in Zambia
This study is trying to understand why some Zambian women give birth early by following them during pregnancy and after delivery while providing them with standard care and health education.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 9000 (estimated) |
| Ages | 15 Years to 49 Years |
| Sex | Female |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (Lusaka and 1 other locations) |
| Trial ID | NCT02738892 on ClinicalTrials.gov |
What this trial studies
This observational cohort study will enroll pregnant women in their first or early second trimester and follow them through delivery and one year postpartum. The study aims to collect detailed medical and obstetrical information, as well as biological samples, to understand the biological mechanisms leading to preterm delivery among Zambian women. Participants will receive standard care and education on nutrition and pregnancy health throughout the study. Regular study visits will be scheduled to monitor maternal and fetal health, and to screen for common pregnancy complications.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 15 years and older, residing in Lusaka, with a singleton or twin pregnancy confirmed by ultrasound.
Not a fit: Patients who are HIV-infected or those who are beyond 24 weeks of gestation at enrollment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new strategies for preventing preterm birth and improving maternal and infant health outcomes.
How similar studies have performed: Other studies have shown success in understanding preterm birth mechanisms, but this specific approach in Zambia is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pregnant women ≥15 years will be eligible to participate. Additionally, participants will: 1. Have a completed screening ultrasound with gestational age \< 20 weeks 2. Be HIV-uninfected at enrollment (NB: prior to Protocol Version 4.0 \[3 Nov 2017\] enrolled both HIV-infected and uninfected women) 3. Have a singleton or twin pregnancy with fetal heart tones confirmed by ultrasound 4. Reside within Lusaka with no plans to relocate during the study follow-up period 5. Be willing to provide written, informed consent 6. Be willing to allow their infants to participate in the study Exclusion criteria: 1. Pregnant women \> 24 weeks' gestation or with screening ultrasound ≥ 16 weeks 2. Infants born to women not enrolled in the study
Where this trial is running
Lusaka and 1 other locations
- Kamwala Health Centre — Lusaka, Zambia (Recruiting)
- University Teaching Hospital — Lusaka, Zambia (Recruiting)
Study contacts
- Principal investigator: Jeff Stringer, MD — University of North Carolina, Chapel Hill
- Study coordinator: Joan Price, MD, MPH
- Email: joan_price@med.unc.edu
- Phone: 260 966 668 312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.