Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Recruiting

• Conditions: Newborn Morbidity; Congenital Disorders; Pregnancy Related; HIV/AIDS

• Registration Number: NCT04405700
• Lead Sponsor: Indiana University

Brief 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.

Study Timeline

• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-28
• Study Start: 2020-09-29
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-15
• Last Update Posted: 2025-08-19
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2800

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy outcomes	At time of delivery	Live Birth, Still Birth, Miscarriage, Termination of pregnancy, Ectopic Pregnancy, Molar Pregnancy, Not Pregnant, Other); also including pre-term delivery (\<37 weeks gestational age) or very pre-term delivery (\<32 weeks gestational age)
Infant/birth outcomes	At 1, 6, and 12 months post-delivery	Congenital abnormalities on newborn surface exam (e.g., extra digit, hydrocephalus, skull defects, eyes, face, mouth/lip/palate, chest, abdomen, anus, limbs, spine (including neural tube defects), hips, genitalia, skin, etc.); also including low birth weight, small for gestational age (\<10th percentile) or very small for gestational age (\<3rd percentile)

Trial Locations

Locations (1)

Moi Teaching and Referral Hospital; 🇰🇪 Eldoret, Kenya