Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Recruiting
Observational Study
HIV/AIDS
Pregnancy Related
Congenital Disorders
Newborn Morbidity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Female
- Study type
- Observational
- Participants needed
- 2,800 (estimated)
- Sponsor
- Indiana University · Other
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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).
Trial Locations
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Eligibility Criteria
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 fr…
Contacts
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