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Measuring Adverse Pregnancy and Newborn Congenital Outcomes

NCT04405700 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2800

Last updated 2025-08-19

No results posted yet for this study

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-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).

Conditions

  • HIV/AIDS
  • Pregnancy Related
  • Congenital Disorders
  • Newborn Morbidity

Interventions

OTHER

Pharmacovigilance surveillance program

The pharmacovigilance (PV) surveillance program will prospectively monitor for 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).

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-29
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04405700 on ClinicalTrials.gov