Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
Indiana University
2,800 participants
Sep 29, 2020
OBSERVATIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria6
- C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:
- Pregnant and enrolled in ANC at the study site;
- Understands English or Swahili.
- a. 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
Exclusion Criteria2
- C2. Data collection for all deliveries at the site:
- C3. Photos/videos of infants with CAs:
Interventions
The pharmacovigilance (PV) surveillance program will prospectively monitor for 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).
Locations(1)
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NCT04405700