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

Pregnancy Related Clinical Trial

— EMBRACE  

Official title:

HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209754
• Other study ID #: MTN-016
• Secondary ID: 3UM1AI0686331073
• Status: Completed
• Start date: October 1, 2009
• Est. completion date: May 6, 2020

Study information

• Verified date: June 2021
• Source: Microbicide Trials Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 873
• Est. completion date: May 6, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Locations

Country	Name	City	State
South Africa	CAPRISA eThekwini	Durban	KwaZulu Natal
South Africa	South African MRC HIV CTU Med Research Council; Botha's Hill Clinical Research Site	Durban
South Africa	South African MRC HIV CTU Med Research Council; Isipingo	Durban
South Africa	South African MRC HIV CTU Med Research Council; Overport	Durban
South Africa	South African MRC HIV CTU Med Research Council; R.K. Khan Hospital	Durban
South Africa	South African MRC HIV CTU Med Research Council; Tongaat	Durban
South Africa	South African MRC HIV CTU Med Research Council; Umkomaas	Durban
South Africa	South African MRC HIV CTU Med Research Council; Verulam	Durban
South Africa	CAPRISA-The Aurum Institute	Johannesburg	Guateng
South Africa	Perinatal HIV Research Unit (PHRU)	Johannesburg	Soweto
South Africa	Wits Reproductive Health Institute (WRHI)	Johannesburg	Gauteng
Uganda	Makerere University-Johns Hopkins University Collaboration	Kampala
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
Zimbabwe	UZ-UCSF HIV Prevention Trials Unit	Chitungwiza	Zengeza
Zimbabwe	UZ-UCSF HIV Prevention Trials Unit	Chitungwiza	Seke South
Zimbabwe	UZ-UCSF HIV Prevention Trials Unit	Harare	Spilhaus

Sponsors (3)

Lead Sponsor	Collaborator
Microbicide Trials Network	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Zimbabwe,  South Africa,  Uganda, 

References & 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 Dapivi — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Infant growth parameters comparison	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.	Duration of Study
Secondary	HIV drug resistance mutations comparison	2. To evaluate the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants.	Duration of Study