EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Microbicide Trials Network
Sponsor:
Collaborators:
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
  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

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

  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
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

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; Isipingo 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; 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
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
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
Gilead Sciences
CONRAD
Investigators
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, 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 October 30, 2014