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

Sponsor

Microbicide Trials Network (Other)

Overall Status

Completed

CT.gov ID

NCT01209754

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

873

Enrollment

Locations

127.1

Actual Duration (Months)

51.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Actual Enrollment :

873 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study

Actual Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

May 6, 2020

Actual Study Completion Date :

May 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Primary Outcome Measures

Pregnancy and delivery outcomes comparison [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
Major malformations comparison [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

Infant growth parameters comparison [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.
HIV drug resistance mutations comparison [Duration of Study]
2. To evaluate the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15213
3	Wits Reproductive Health Institute (WRHI)	Johannesburg	Gauteng	South Africa	2001
4	CAPRISA-The Aurum Institute	Johannesburg	Guateng	South Africa	2193
5	CAPRISA eThekwini	Durban	KwaZulu Natal	South Africa	4001
6	Perinatal HIV Research Unit (PHRU)	Johannesburg	Soweto	South Africa	1804
7	South African MRC HIV CTU Med Research Council; Botha's Hill Clinical Research Site	Durban		South Africa
8	South African MRC HIV CTU Med Research Council; Isipingo	Durban		South Africa
9	South African MRC HIV CTU Med Research Council; Overport	Durban		South Africa
10	South African MRC HIV CTU Med Research Council; R.K. Khan Hospital	Durban		South Africa
11	South African MRC HIV CTU Med Research Council; Tongaat	Durban		South Africa
12	South African MRC HIV CTU Med Research Council; Umkomaas	Durban		South Africa
13	South African MRC HIV CTU Med Research Council; Verulam	Durban		South Africa
14	Makerere University-Johns Hopkins University Collaboration	Kampala		Uganda
15	UZ-UCSF HIV Prevention Trials Unit	Chitungwiza	Seke South	Zimbabwe
16	UZ-UCSF HIV Prevention Trials Unit	Harare	Spilhaus	Zimbabwe
17	UZ-UCSF HIV Prevention Trials Unit	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)