Monitoring Pregnancy and Newborn Health Outcomes Including Congenital Abnormalities in HIV-Positive and HIV-Negative Women and Their Infants A Study with the International Epidemiology Databases to Evaluate Consortium

What this Trial Is About

Researchers are studying a pharmacovigilance surveillance program to monitor adverse pregnancy and infant outcomes, including congenital abnormalities, among HIV-positive and HIV-negative women and their infants. This study involves clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium IeDEA and aims to develop a multiregional system to better understand how antiretroviral treatment relates to pregnancy and birth outcomes. The study has three parts first, pregnant women attending antenatal clinics at two health facilities in western Kenya will be enrolled prospectively, including all HIV-positive and a sample of HIV-negative women. Data will be collected from medical records at delivery for all women delivering at the site. Infants suspected of having congenital abnormalities will be assessed through photos and videos reviewed by experts. Second, cross-sectional data will be collected retrospectively from delivery records at the site. Third, the study will establish standardized protocols and a Data Coordinating Center at Indiana University to support data collection and analysis across multiple regions. Participants will be monitored at delivery and followed up at 1, 6, and 12 months after birth to assess pregnancy and infant outcomes. Mothers of infants with major congenital abnormalities will be contacted by phone during this period to check on their infants health and care status. The study collects detailed medical record data, images of infants with abnormalities, and follow-up information to evaluate pregnancy outcomes and infant health over time.

Measuring Adverse Pregnancy and Newborn Congenital Outcomes