HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 873
- 试验地点
- 15
- 主要终点
- Pregnancy and delivery outcomes comparison
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •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.
- •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
排除标准
- •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
结局指标
主要结局
Pregnancy and delivery outcomes comparison
时间窗: 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
时间窗: 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.
次要结局
- Infant growth parameters comparison(Duration of Study)
- HIV drug resistance mutations comparison(Duration of Study)