Study of Early Low-Dose Aspirin to Prevent Pregnancy Loss and Preeclampsia in Women at Risk Phase 3 Randomized Trial Comparing Aspirin Dosing Starting Before 7 Weeks of Pregnancy

What this Trial Is About

Researchers are studying the effects of early use of low-dose aspirin in pregnant women who have risk factors for preeclampsia or pregnancy loss. The study aims to find out if starting aspirin at a specific dose and time during pregnancy can lower the chances of developing preeclampsia or experiencing pregnancy loss compared to the usual recommendations. This is a Phase 3 clinical trial led by the University of Pennsylvania. Participants will be randomly assigned to one of two groups. One group will take two 81mg aspirin tablets daily from the start of the trial until delivery. The other group will take placebo pills until 12 weeks of pregnancy and then switch to one placebo and one 81mg aspirin tablet daily until delivery. The treatment starts no later than 6 weeks and 6 days of pregnancy and continues through delivery. During the study, participants will be monitored from enrollment through delivery, with researchers tracking outcomes such as preeclampsia, pregnancy loss, and other pregnancy complications. The main results measured include the occurrence of preeclampsia from 20 weeks of pregnancy to delivery and pregnancy loss up to 24 weeks gestation. Additional outcomes involve various pregnancy-related conditions and birth outcomes. The study includes safety monitoring and lasts through the entire pregnancy period, with careful follow-up until delivery.

APPLE: Aspirin to Prevent Pregnancy Loss and Preeclampsia