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Taking people in KenyaNo phase

Monitors pregnancy and newborn outcomes in women with and without HIV

Builds a monitoring program for pregnancy and birth defects in women with HIV.

Plain-language title generated from the registry record
Registry title: Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Key facts

Where
Eldoret, KenyaSee the site

Where in Kenya

  • Moi Teaching and Referral HospitalEldoret, KenyaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Indiana University
Trial code
NCT04405700
Record updated
24 August 2026
Original description
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).Read full original descriptionShow less

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

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).

Inclusion: Pregnant and enrolled in ANC at the study site; Understands English or Swahili; All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none); C2. Data collection for all deliveries at the site:; Infant is delivered at the site and results in the infant/stillbirth being registered at the site; The infant is live or stillborn at ≥ 24 weeks estimated gestational age; The infant has a suspected CA on surface exam.

Exclusion: C3. Photos/videos of infants with CAs:.

C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:.

ClinicalTrials.gov NCT04405700