EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) (EMBRACE)
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ClinicalTrials.gov Identifier: NCT01209754 |
Recruitment Status
:
Recruiting
First Posted
: September 27, 2010
Last Update Posted
: August 30, 2017
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Condition or disease |
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Pregnancy Related |
Study Type : | Observational |
Estimated Enrollment : | 950 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study |
Study Start Date : | October 2009 |
Estimated Primary Completion Date : | November 2020 |
Estimated Study Completion Date : | November 2020 |

Group/Cohort |
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Pregnant Women
Pregnant women exposed to an HIV prevention study agent during pregnancy
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Infant
Infants resulting from pregnancies where there exists maternal HIV prevention agent exposure
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- Pregnancy and delivery outcomes comparison [ Time Frame: Duration of Study ]
To compare adverse pregnancy and delivery outcomes between participant mothers assigned to an active agent with those of mothers assigned to placebo/control. Pregnancy and delivery outcomes of interest are:
- delivery prior to 37 completed weeks of gestation
- stillbirth or intrauterine fetal demise (≥ 20 weeks)
- spontaneous abortion (< 20 weeks)
- ectopic pregnancy
- intrapartum hemorrhage
- postpartum hemorrhage
- non-reassuring fetal status
- chorioamnionitis
- hypertensive disorders of pregnancy
- gestational diabetes
- intrauterine growth restriction
- Major malformations comparison [ Time Frame: Duration of Study ]To compare the prevalence of major malformations identified in the first year of life between infants of mothers assigned to an active agent with those of infants of mothers assigned to placebo/control. Major malformations are defined as structural abnormalities with surgical, medical, or cosmetic importance.
- Infant growth parameters comparison [ Time Frame: Duration of Study ]To compare growth parameters in the first year of life between infants of mothers assigned to an active agent with those of mothers assigned to placebo/control. Growth parameters of interest are weight, length, and head circumference at birth, one month, six months and 12 months.
- HIV drug resistance mutations comparison [ Time Frame: Duration of Study ]2. To evaluate the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants.

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria: Mother cohort
- Able and willing to provide written informed consent to take part in the study
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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.
Inclusion Criteria: 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 Criteria: 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
Exclusion Criteria: Infant 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
- Has reached 1 year birth date

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01209754
Contact: Richard Beigi, MD | (412)-641-3313 | rbeigi@mail.magee.edu |
United States, Alabama | |
University of Alabama at Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
United States, Pennsylvania | |
University of Pittsburgh | Recruiting |
Pittsburgh, Pennsylvania, United States, 15213 | |
South Africa | |
Wits Reproductive Health Institute (WRHI) | Recruiting |
Johannesburg, Gauteng, South Africa, 2001 | |
CAPRISA-The Aurum Institute | Completed |
Johannesburg, Guateng, South Africa, 2193 | |
CAPRISA eThekwini | Recruiting |
Durban, KwaZulu Natal, South Africa, 4001 | |
Perinatal HIV Research Unit (PHRU) | Completed |
Johannesburg, Soweto, South Africa, 1804 | |
South African MRC HIV CTU Med Research Council; Botha's Hill Clinical Research Site | Recruiting |
Durban, South Africa | |
South African MRC HIV CTU Med Research Council; Isipingo | Recruiting |
Durban, South Africa | |
South African MRC HIV CTU Med Research Council; Overport | Completed |
Durban, South Africa | |
South African MRC HIV CTU Med Research Council; R.K. Khan Hospital | Recruiting |
Durban, South Africa | |
South African MRC HIV CTU Med Research Council; Tongaat | Recruiting |
Durban, South Africa | |
South African MRC HIV CTU Med Research Council; Umkomaas | Completed |
Durban, South Africa | |
South African MRC HIV CTU Med Research Council; Verulam | Recruiting |
Durban, South Africa | |
Uganda | |
Makerere University-Johns Hopkins University Collaboration | Recruiting |
Kampala, Uganda | |
Zimbabwe | |
UZ-UCSF HIV Prevention Trials Unit | Recruiting |
Chitungwiza, Seke South, Zimbabwe | |
UZ-UCSF HIV Prevention Trials Unit | Recruiting |
Harare, Spilhaus, Zimbabwe | |
UZ-UCSF HIV Prevention Trials Unit | Recruiting |
Chitungwiza, Zengeza, Zimbabwe |
Study Chair: | Richard Beigi, MD | Microbicide Trials Network |
Additional Information:
Responsible Party: | Microbicide Trials Network |
ClinicalTrials.gov Identifier: | NCT01209754 History of Changes |
Other Study ID Numbers: |
MTN-016 3UM1AI068633 ( U.S. NIH Grant/Contract ) 10737 ( Other Grant/Funding Number: DAIDS Protocol ID ) |
First Posted: | September 27, 2010 Key Record Dates |
Last Update Posted: | August 30, 2017 |
Last Verified: | August 2017 |
Keywords provided by Microbicide Trials Network:
Pregnancy Chemoprophylactic Exposure Mother |
Infant malformations HIV |