Study timeline: 8/10/2023-7/31/2028
Investigators: Barnhart, K; Schisterman, E
Funding: Eunice Kennedy Shriver National Institute of Child Health and Human Development
This is a parallel assignment, randomized, double blind clinical trial of double low-dose aspirin (162 mg/day) begun no later than 6 weeks 6 days gestation, through delivery, to investigate the effects of early initiation of prophylactic aspirin therapy compared to standard of care (placebo through 12 weeks’ gestation, 81 mg aspirin thereafter through delivery) on reducing risk of both pregnancy loss and preeclampsia in pregnant people with one or more risk factors. The study aims to evaluate the effectiveness of double low-dose aspirin therapy initiated by 6 weeks 6 days gestation compared to standard of care on preeclampsia. Additionally, the study will evaluate the effectiveness of double low-dose aspirin therapy initiated by 6 weeks 6 days gestation compared to standard of care on pregnancy loss. The study population includes pregnant individuals presenting for care prior to 7 weeks gestation, who may be at a greater risk of preeclampsia or pregnancy loss. The study will recruit from sites within the Penn Medicine healthcare system, and surrounding geographic area (Delaware, New Jersey and Pennsylvania).
The Clinical Research Collaboration Unit (CRCU) provides project management, data management and research technology services to support this project.