EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) (EMBRACE)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified September 2014 by Microbicide Trials Network
Sponsor:
Microbicide Trials Network
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Gilead Sciences
CONRAD
Information provided by (Responsible Party):
Microbicide Trials Network
ClinicalTrials.gov Identifier:
NCT01209754
First received: September 23, 2010
Last updated: September 17, 2014
Last verified: September 2014
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Purpose
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.
| Condition |
|---|
|
Pregnancy Related |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study |
Resource links provided by NLM:
Further study details as provided by Microbicide Trials Network:
Primary Outcome Measures:
- Pregnancy and delivery outcomes comparison [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Infant growth parameters comparison [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]2. To evaluate the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants.
| Estimated Enrollment: | 950 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | November 2020 |
| Estimated Primary Completion Date: | November 2020 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Pregnant Women
Pregnant women exposed to an HIV prevention study agent during pregnancy
|
|
Infant
Infants resulting from pregnancies where there exists maternal HIV prevention agent exposure
|
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 of maternal exposures to investigational HIV prevention agents. Approximately 550 pregnant participants and 400 live infants will be offered enrollment. The study population will consist of current or recent female participants identified as becoming pregnant during microbicide or PrEP trials, or who have had planned exposures in pregnancy safety studies. This study will also include infants resulting from those pregnancies. This protocol will monitor for adverse pregnancy and delivery outcomes, monitor the prevalence of major malformations, evaluate growth parameters of infants during the first year of life, and evaluate the prevalence and persistence of HIV drug resistance mutations in a cohort of infants who were either exposed to active study agents or not exposed to active study agents while in utero.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
The study population will consist of female participants who become or became pregnant during HIV prevention agent trials, or who have or had planned exposures in pregnancy safety studies, and the infants resulting from those pregnancies. Mother participants must still be pregnant, or have had a pregnancy outcome diagnosis less than one year before screening/enrollment, and infant participants must be less than one year old. The study may include HIV-uninfected and -infected participants. Mothers may participate in EMBRACE without participation of their infants; however, infants whose mothers have not enrolled in EMBRACE will not participate.
Criteria
Inclusion Criteria: 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.
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209754
Please refer to this study by its ClinicalTrials.gov identifier: NCT01209754
Contacts
| Contact: Richard Beigi, MD | (412)-641-3313 | rbeigi@mail.magee.edu |
Locations
| 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 | Recruiting |
| Johannesburg, Guateng, South Africa, 2193 | |
| CAPRISA eThekwini | Recruiting |
| Durban, KwaZulu Natal, South Africa, 4001 | |
| Perinatal HIV Research Unit (PHRU) | Recruiting |
| 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 | Recruiting |
| 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 | Recruiting |
| 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 | |
Sponsors and Collaborators
Microbicide Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
Gilead Sciences
CONRAD
Investigators
| Study Chair: | Richard Beigi, MD | Microbicide Trials Network |
More Information
| Responsible Party: | Microbicide Trials Network |
| ClinicalTrials.gov Identifier: | NCT01209754 History of Changes |
| Other Study ID Numbers: | MTN-016 3UM1AI068633 10737 |
| Study First Received: | September 23, 2010 |
| Last Updated: | September 17, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Microbicide Trials Network:
|
Pregnancy Chemoprophylactic Exposure Mother |
Infant malformations HIV |
ClinicalTrials.gov processed this record on September 27, 2016