Status:
COMPLETED
EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)
Lead Sponsor:
Microbicide Trials Network
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy Related
Eligibility:
All Genders
Brief 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 invest...
Detailed 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 study ...
Eligibility Criteria
Inclusion
- Mother cohort
- Able and willing to provide written informed consent to take part in the study
- During participation in a parent protocol, has/had a known confirmed pregnancy, meeting at least one of the following sets of criteria in A or B:
- A. Two consecutive monthly study visits, at least 14 days apart, with positive pregnancy tests, in the absence of signs/symptoms of miscarriage or participant report of pregnancy termination.
- B. One or more of the following assessments:
- Auscultation of fetal heart tones
- Positive pregnancy test confirmed by clinic staff in the presence of clinically confirmed enlarged uterus
- Positive pregnancy test confirmed by clinic staff in the presence of missed menses (no menses occurring at least 60 days from the first day of the last menses) by participant report (For amenorrheic or irregularly cycling women, two consecutive positive hCG tests (criterion A) or any of the other clinical signs of pregnancy included under the criteria B listing will be used to confirm MTN-016 eligibility).
- Clinical assessment of fetal movement
- Demonstration of pregnancy by ultrasound
- Able and willing to provide adequate locator information, as defined in site SOPs
- Note: Participants do not have to be currently enrolled or engaged in follow-up in a parent protocol to participate in EMBRACE.
- Infant cohort
- Has written informed consent provided by parent(s)/guardian to take part in the study in a manner consistent with local standards, site Institutional Review Board (IRB) guidance and the US Code of Federal Regulations (CFR)
- Born to EMBRACE participant mother from pregnancy concurrent with participation in parent study
Exclusion
- Mother cohort
- Has any condition that in the opinion of the investigator or designee, would complicate interpretation of study outcome data, make participation in the study unsafe, or otherwise interfere with achieving the study objectives
- Pregnancy outcome occurred greater than one year ago
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 6 2020
Estimated Enrollment :
873 Patients enrolled
Trial Details
Trial ID
NCT01209754
Start Date
October 1 2009
End Date
May 6 2020
Last Update
June 21 2021
Active Locations (17)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
3
Wits Reproductive Health Institute (WRHI)
Johannesburg, Gauteng, South Africa, 2001
4
CAPRISA-The Aurum Institute
Johannesburg, Guateng, South Africa, 2193