Last reviewed · How we verify
NCT01209754: EMBRACE
EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)
trial in Pregnancy Related in 873 participants. Completed in 6 May 2020.
6 May 2020
Quick facts
| Lead sponsor | Microbicide Trials Network |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 873 |
| Start date | 1 October 2009 |
| Primary completion | 6 May 2020 |
| Estimated completion | 6 May 2020 |
| Sites | 17 locations across Zimbabwe, South Africa, United States, Uganda |
Conditions studied
- Pregnancy Related — all drugs for Pregnancy Related →
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):
-
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 -
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:
- PubMed search for NCT01209754
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pregnancy Related
Currently open trials in the same condition.
- NCT05909761 — Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregn · recruiting
- NCT07517549 — Sexual Health Education During Pregnancy · NA · recruiting
- NCT07293559 — Understanding Practices of Lactation and Infant Feeding Together With Women With HIV in the United States · recruiting
- NCT07518550 — Maternal and Fetal Electrocardiograms Separation Algorithm · NA · recruiting
- NCT06965530 — Nourishing Tomorrow: Role of Medically Tailored Groceries in Addressing Food Insecurity During Pregnancy · NA · recruiting
Other Microbicide Trials Network trials
Trials by the same sponsor.
- NCT04023799 — Couple User Preferences in Dual Purpose Prevention Products · completed
- NCT03671239 — Rectal Microbicide Acceptability, Tolerability and Adherence · NA · completed
- NCT03648931 — Microbicide/PrEP Acceptability Among Mothers and Male Partners in Africa · completed
- NCT02702895 — Assessment of ASPIRE and HOPE Adherence · completed
- NCT00514098 — Observational Study of HIV Infected Women Previously Enrolled in Other Microbicide Trials · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01209754 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Microbicide Trials Network
- Last refreshed: 21 June 2021
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