Actively Recruiting
Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
Led by Indiana University · Updated on 2025-08-19
2800
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a pharmacovigilance surveillance program to monitor adverse pregnancy and infant outcomes, including congenital abnormalities, among HIV-positive and HIV-negative women and their infants. This study involves clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA) and aims to develop a multiregional system to better understand how antiretroviral treatment relates to pregnancy and birth outcomes. The study has three parts: first, pregnant women attending antenatal clinics at two health facilities in western Kenya will be enrolled prospectively, including all HIV-positive and a sample of HIV-negative women. Data will be collected from medical records at delivery for all women delivering at the site. Infants suspected of having congenital abnormalities will be assessed through photos and videos reviewed by experts. Second, cross-sectional data will be collected retrospectively from delivery records at the site. Third, the study will establish standardized protocols and a Data Coordinating Center at Indiana University to support data collection and analysis across multiple regions. Participants will be monitored at delivery and followed up at 1, 6, and 12 months after birth to assess pregnancy and infant outcomes. Mothers of infants with major congenital abnormalities will be contacted by phone during this period to check on their infants' health and care status. The study collects detailed medical record data, images of infants with abnormalities, and follow-up information to evaluate pregnancy outcomes and infant health over time.
CONDITIONS
Brief Title
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women enrolled in antenatal care at the study site
- Women who understand English or Swahili
- Infants of enrolled women at any gestational age
- Women who deliver at the study site with delivery registered
- Live or stillborn infants delivered at the site registered at the site
- Infants live or stillborn at 24 weeks or more gestational age with suspected congenital abnormalities
You will not qualify if you...
- Women with any physical or mental disability preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment during pregnancy through delivery
Participants who undergo routine antenatal care are observed through data collection from medical records and follow-up contacts to monitor pregnancy and infant outcomes.
Visits aligned with routine antenatal care and delivery at the study site
Duration - 12 months post-delivery
Participants with infants suspected of having congenital abnormalities are followed up at 1, 6, and 12 months post-delivery to assess infant health and care engagement.
3 follow-up contacts by phone
Trial Site Locations
Total: 1 location
1
Moi Teaching and Referral Hospital
Eldoret, Kenya, 30100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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