Measuring Adverse Pregnancy and Newborn Congenital Outcomes

RecruitingOBSERVATIONAL
Enrollment

2,800

Participants

Timeline

Start Date

September 29, 2020

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2026

Conditions
HIV/AIDSPregnancy RelatedCongenital DisordersNewborn Morbidity
Interventions
OTHER

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).

Trial Locations (1)

30100

RECRUITING

Moi Teaching and Referral Hospital, Eldoret

All Listed Sponsors
lead

Indiana University

OTHER