NCT04405700Recruiting
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2800 (estimated)
- First submitted
- 22 May 2020
- Start date
- 29 Sept 2020
- Primary completion date
- 31 May 2031
- Lead sponsor
- Indiana University
- Diseases
- HIV
- NCT number
- NCT04405700
What you commit to
- Study type: Observational
- Planned participants: 2800
- From 29 Sept 2020 to the primary completion date, 31 May 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- C3. Photos/videos of infants with CAs:
Who the study is looking for
- Pregnant and enrolled in ANC at the study site;
- Understands English or Swahili.
- 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:
- Infant is delivered at the site and results in the infant/stillbirth being registered at the site
- The infant is live or stillborn at ≥ 24 weeks estimated gestational age
- The infant has a suspected CA on surface exam
Criteria the registry did not label
- C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moi Teaching and Referral Hospital Coordinator of this site? Confirm its status | Eldoret | Kenya | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.