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. Participants will be enrolled as early in pregnancy as possible to maximize data validity. 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 outcomes, evaluate growth parameters of infants during the first year of life, and collect information on the prevalence of major malformations in infants during the first year of life. The study will also evaluate the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants and provide a cohort of infants not exposed to active study agents during pregnancy.
The protocol was amended in February 2014 with modifications made to the anticipated sample size, study duration, study objectives, and endpoints.
US National Institutes of Health
Prospective observational cohort investigation of prevention agent and control group exposures in pregnancy