Actively Recruiting

FEMALE
Healthy Volunteers
NCT04405700

Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Led by Indiana University · Updated on 2025-08-19

2800

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Who Can Participate

FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant and enrolled in antenatal care at the study site
  • Understands English or Swahili
  • All infants born at any gestational age to enrolled women are included
  • Woman delivers at the study site and the delivery is registered there
  • Infant is delivered at the site and the infant or stillbirth is registered
  • Infants live or stillborn at 24 or more weeks gestational age with suspected congenital abnormalities on surface exam are included
Not Eligible

You will not qualify if you...

  • Any physical or mental disability that prevents the woman from providing informed consent
  • No exclusion criteria for infants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Moi Teaching and Referral Hospital

Eldoret, Kenya, 30100

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here