Actively Recruiting
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Led by Indiana University · Updated on 2025-08-19
2800
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant and enrolled in antenatal care at the study site
- Understands English or Swahili
- All infants born at any gestational age to enrolled women are included
- Woman delivers at the study site and the delivery is registered there
- Infant is delivered at the site and the infant or stillbirth is registered
- Infants live or stillborn at 24 or more weeks gestational age with suspected congenital abnormalities on surface exam are included
You will not qualify if you...
- Any physical or mental disability that prevents the woman from providing informed consent
- No exclusion criteria for infants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Moi Teaching and Referral Hospital
Eldoret, Kenya, 30100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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