Status:
RECRUITING
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Lead Sponsor:
Indiana University
Conditions:
HIV/AIDS
Pregnancy Related
Eligibility:
FEMALE
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-po...
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 Pr...
Eligibility Criteria
Inclusion
- C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:
- Inclusion criteria for women
- Pregnant and enrolled in ANC at the study site;
- 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
- The infant is live or stillborn at ≥ 24 weeks estimated gestational age
- The infant has a suspected CA on surface exam
- Exclusion criteria for infants (none)
Exclusion
Key Trial Info
Start Date :
September 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
2800 Patients enrolled
Trial Details
Trial ID
NCT04405700
Start Date
September 29 2020
End Date
May 31 2026
Last Update
August 19 2025
Active Locations (1)
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1
Moi Teaching and Referral Hospital
Eldoret, Kenya, 30100