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EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)

NCT01209754 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 873

Last updated 2021-06-21

No results posted yet for this study

Summary

The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) is a prospective observational cohort investigation of exposures to study agents under investigation for HIV prevention. The study population will consist of female participants who are identified as becoming pregnant during their participation in a microbicide or PrEP trial, or who have had planned exposures in pregnancy safety studies as well as their babies resulting from these pregnancies. This study will only enroll babies who have not yet reached their 1 year birth date.

Conditions

  • Pregnancy Related

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Microbicide Trials Network

    lead NETWORK

Principal Investigators

  • Richard Beigi, MD · Microbicide Trials Network

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-01
Primary Completion
2020-05-06
Completion
2020-05-06

Countries

  • United States
  • South Africa
  • Uganda
  • Zimbabwe

Study Locations

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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 NCT01209754 on ClinicalTrials.gov