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NCT01209754: EMBRACE

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

Completed Last updated 21 June 2021
What this trial tests

trial in Pregnancy Related in 873 participants. Completed in 6 May 2020.

Timeline
1 October 2009
Primary endpoint
6 May 2020
6 May 2020

Quick facts

Lead sponsorMicrobicide Trials Network
StatusCompleted
Study typeOBSERVATIONAL
Enrollment873
Start date1 October 2009
Primary completion6 May 2020
Estimated completion6 May 2020
Sites17 locations across Zimbabwe, South Africa, United States, Uganda

Conditions studied

Sponsor

Microbicide Trials Network

Who can join

Eligibility, any sex, with Pregnancy Related. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Where are the pregnant and breastfeeding women in new pre-exposure prophylaxis trials? The imperative to overcome the evidence gap.
    Joseph Davey DL, Bekker LG, Bukusi EA, Chi BH, et al · · 2022 · cited 35× · PMID 35090604 · DOI 10.1016/s2352-3018(21)00280-0
  2. Evaluation of Research Accessibility and Data Elements of HIV Registries.
    Mayer CS, Williams N, Fung KW, Huser V. · · 2019 · cited 2× · PMID 31550214 · DOI 10.2174/1570162x17666190924195439

Verify or expand the search:

Other recruiting trials for Pregnancy Related

Currently open trials in the same condition.

Other Microbicide Trials Network trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01209754.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing