NCT04405700

Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,800 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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).

Detailed description

In part 1 of this study, the investigators will use a mixed prospective and cross-sectional cohort study design to implement a PV program at two health facilities affiliated with the Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators will analyze these data to examine any associations between antiretroviral treatment (ART) and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create standardized protocols and data exchange standards within IeDEA to enable the merging and analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and archiving data from the study in Kenya as well as data collected through a similar, ongoing study at health facilities in South Africa affiliated with IeDEA. This study will establish a multiregional PV infrastructure within IeDEA that can be further scaled within the broader IeDEA network.

Conditions

• HIV/AIDS
• Pregnancy Related
• Congenital Disorders
• Newborn Morbidity

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-09-29
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2020-05-28
• Last updated: 2025-08-19

Locations

1 site across 1 country: Kenya