EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)
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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 microbicide or PrEP trials, 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 |
|---|
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Pregnancy Outcome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study |
- Pregnancy loss as evidenced by negative urine pregnancy test, clinical confirmation of intrauteine demise, or ultrasound evidence of pregnancy loss at any gestation. [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
- Major malformation (structural abnormality with surgical, medical, or cosmetic importance) identified before one year of life [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
- Adverse pregnancy outcomes, including but not limited to ectopic pregnancy, hypertensive disorders of pregnancy, gestational diabetes, preterm delivery, and postpartum hemorrhage [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
- Growth parameters in the first year of life (birth, 1, 6, and 12 months) [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]Birth weight; Serial length, weight, and head circumference
| Estimated Enrollment: | 800 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (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 500 pregnant participants and 300 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 outcomes, evaluate growth parameters of infants during the first year of life, and provide a cohort of infants not exposed to active study agents during pregnancy. In an exploratory manner, it will monitor for select risks of prevention agents identified during preclinical reproductive toxicology studies by trimester of exposure, evaluate the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants, and compare the results of developmental screening at select time points in the first year of life among participating infants.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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 with positive pregnancy tests
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 by participant report
- Clinical assessment of fetal movement
- Demonstration of pregnancy by ultrasound
- Able and willing to provide adequate locator information, as defined in site SOPs
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 was diagnosed greater than one year ago
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| 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 | 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; Tongaat | Recruiting |
| Durban, South Africa | |
| South African MRC HIV CTU Med Research Council; Verulam | Recruiting |
| Durban, South Africa | |
| 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; R.K. Khan Hospital | 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; Umkomaas | 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 |
More Information
No publications provided
| Responsible Party: | Microbicide Trials Network |
| ClinicalTrials.gov Identifier: | NCT01209754 History of Changes |
| Other Study ID Numbers: | MTN-016, 5U01AI068633-03, 10737 |
| Study First Received: | September 23, 2010 |
| Last Updated: | August 24, 2011 |
| 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 March 14, 2013
