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

NCT01209754 | Completed DMC

• 3 other identifiers: MTN-0163UM1AI06863310737
• Study Type: observational
• Target: 873
• Locations: 4 countries
• Sites: 17

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.

Conditions

Pregnancy Related

Keywords

Pregnancy; Chemoprophylactic Exposure; Mother; Infant; malformations; HIV

Outcome Measures

Primary Outcomes (2)

• Pregnancy and delivery outcomes comparison

  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

  Duration of Study

• Major malformations comparison

  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.

  Duration of Study

Secondary Outcomes (2)

• Infant growth parameters comparison

  Duration of Study

• HIV drug resistance mutations comparison

  Duration of Study

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Microbicide Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Wits Reproductive Health Institute (WRHI)

Johannesburg, Gauteng, 2001, South Africa

Location

CAPRISA-The Aurum Institute

Johannesburg, Guateng, 2193, South Africa

Location

CAPRISA eThekwini

Durban, KwaZulu-Natal, 4001, South Africa

Location

Perinatal HIV Research Unit (PHRU)

Johannesburg, Soweto, 1804, South Africa

Location

South African MRC HIV CTU Med Research Council; Botha's Hill Clinical Research Site

Durban, South Africa

Location

South African MRC HIV CTU Med Research Council; Isipingo

Durban, South Africa

Location

South African MRC HIV CTU Med Research Council; Overport

Durban, South Africa

Location

South African MRC HIV CTU Med Research Council; R.K. Khan Hospital

Durban, South Africa

Location

South African MRC HIV CTU Med Research Council; Tongaat

Durban, South Africa

Location

South African MRC HIV CTU Med Research Council; Umkomaas

Durban, South Africa

Location

South African MRC HIV CTU Med Research Council; Verulam

Durban, South Africa

Location

Makerere University-Johns Hopkins University Collaboration

Kampala, Uganda

Location

UZ-UCSF HIV Prevention Trials Unit

Chitungwiza, Seke South, Zimbabwe

Location

UZ-UCSF HIV Prevention Trials Unit

Harare, Spilhaus, Zimbabwe

Location

UZ-UCSF HIV Prevention Trials Unit

Chitungwiza, Zengeza, Zimbabwe

Location

Related Publications (2)

• Makanani B, Balkus JE, Jiao Y, Noguchi LM, Palanee-Phillips T, Mbilizi Y, Moodley J, Kintu K, Reddy K, Kabwigu S, Jeenariain N, Harkoo I, Mgodi N, Piper J, Rees H, Scheckter R, Beigi R, Baeten JM. Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy. J Acquir Immune Defic Syndr. 2018 Dec 15;79(5):566-572. doi: 10.1097/QAI.0000000000001861.

  PMID: 30383589 RESULT

• Mhlanga FG, Noguchi L, Balkus JE, Kabwigu S, Scheckter R, Piper J, Watts H, O'Rourke C, Torjesen K, Brown ER, Hillier SL, Beigi R. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials. HIV Clin Trials. 2018 Feb;19(1):8-14. doi: 10.1080/15284336.2017.1411419. Epub 2017 Dec 21.

  PMID: 29268654 RESULT

Study Officials

• Richard Beigi, MD

  Microbicide Trials Network

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 27, 2010
• Study Start: October 1, 2009
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: June 21, 2021

Record last verified: 2021-06

Locations

ZI (3); US (2); UG (1); ZA (11)