Monitoring pregnancy and newborn outcomes in HIV-positive and HIV-negative women
Official title: Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
Run by Indiana University · NCT04405700 · Data updated 2026-11-12
This study is trying to see how pregnancy and baby health outcomes differ between women with and without HIV to improve care for both groups.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 2800 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Eldoret) |
| Status | Recruiting |
| Started | September 29, 2020 |
| Main results expected | May 31, 2031 |
| Study ends | May 31, 2031 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT04405700 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include HIV-positive and HIV-negative pregnant women enrolled in antenatal care at the study site.
✕Probably not a fit
Patients with physical or mental disabilities that prevent informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop a pharmacovigilance surveillance program to monitor adverse pregnancy and infant outcomes, including congenital abnormalities, among HIV-positive and HIV-negative women and their infants. It will utilize a mixed prospective and cross-sectional cohort design at health facilities in western Kenya. The study will analyze data to explore associations between antiretroviral treatment and pregnancy and infant outcomes, while also establishing standardized protocols for data exchange within the International Epidemiology Databases to Evaluate consortium. A Data Coordinating Center at Indiana University will facilitate data collection and analysis across multiple regions.
Why it matters
Potential benefit: If successful, this study could improve understanding of the safety of antiretroviral treatments during pregnancy and their impact on newborn health.
How similar studies have gone: Other studies have shown success in pharmacovigilance approaches for monitoring pregnancy outcomes, indicating potential for this study's methodology.
Who can join: the full rules
Show full inclusion / exclusion criteria
C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site: Inclusion criteria for women 1. Pregnant and enrolled in ANC at the study site; 2. Understands English or Swahili. Exclusion criteria for women a. Any physical or mental disability that prevents the woman from providing informed consent Inclusion criteria for infants a. All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none) C2. Data collection for all deliveries at the site: Inclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site Exclusion criteria for women (none) Inclusion criteria for live/stillborn infants a. Infant is delivered at the site and results in the infant/stillbirth being registered at the site Exclusion criteria for infants (none) C3. Photos/videos of infants with CAs: Inclusion criteria for infants 1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age 2. The infant has a suspected CA on surface exam Exclusion criteria for infants (none)
Where it's running
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Moi Teaching and Referral Hospital
Eldoret, Kenya Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.