Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorIndiana University
About this trial
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).
Eligibility criteria
Qualifiers
Pregnant and enrolled in ANC at the study site;
Understands English or Swahili.
Disqualifiers
The infant is live or stillborn at ≥ 24 weeks estimated gestational age
The infant has a suspected CA on surface exam
Trial design
Treatments tested in this trial
- Pharmacovigilance surveillance program
Treatment groups
2,800 Participants
are divided into 3 treatment groupsLocations
1Moi Teaching and Referral Hospital30100, Eldoret Kenya
Sponsors and collaborators
Indiana University
Lead sponsor
Source ClinicalTrials.gov