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Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Sponsor: Indiana University
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).
Official title: Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
Key Details
Gender
FEMALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
2800
Start Date
2020-09-29
Completion Date
2026-05-31
Last Updated
2025-08-19
Healthy Volunteers
Yes
Interventions
Pharmacovigilance surveillance program
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)
Moi Teaching and Referral Hospital
Eldoret, Kenya