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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
Sponsor:
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

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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 or disease
Pregnancy Related

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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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
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

  1. Able and willing to provide written informed consent to take part in the study

  2. 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
  3. 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

  1. 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)
  2. Born to EMBRACE participant mother from pregnancy concurrent with participation in parent study

Exclusion Criteria: Mother cohort

  1. 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
  2. Pregnancy outcome occurred greater than one year ago

Exclusion Criteria: Infant cohort

  1. 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
  2. Has reached 1 year birth date
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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 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
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here for the Microbicide Trials Network Web site  This link exits the ClinicalTrials.gov site

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