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Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Recruitingn/aAges any - anyFemaleIndiana University
NCT04405700 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site: Inclusion criteria for women 1. Pregnant and enrolled in ANC at the study site; 2. Understands English or Swahili. Exclusion criteria for women a. Any physical or mental disability that prevents the woman from providing informed consent Inclusion criteria for infants a. 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: Inclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site Exclusion criteria for women (none) Inclusion criteria for live/stillborn infants a. Infant is delivered at the site and results in the infant/stillbirth being registered at the site Exclusion criteria for infants (none) C3. Photos/videos of infants with CAs: Inclusion criteria for infants 1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age 2. The infant has a suspected CA on surface exam Exclusion criteria for infants (none)
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What it tests

  • Pharmacovigilance surveillance program
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Where

1 site
Moi Teaching and Referral Hospital
Eldoret, Kenya
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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