Study protocol for the randomised controlled trial: combined multimarker screening and randomised patient treatment...

Area of Science:

• Obstetrics and Gynecology
• Maternal-Fetal Medicine
• Clinical Trial Design

Background:

• Pre-eclampsia (PE) is a significant cause of maternal and perinatal complications, affecting 2-3% of pregnancies.
• Effective screening for preterm PE is possible using a combination of maternal factors and biomarkers at 11-13 weeks gestation.
• Prophylactic low-dose aspirin has shown potential in reducing PE prevalence.

Purpose of the Study:

• To evaluate the efficacy of low-dose aspirin in preventing preterm pre-eclampsia.
• To determine if prophylactic aspirin initiated at 11-13 weeks gestation reduces the incidence of preterm PE.
• To assess the impact of aspirin on maternal and perinatal outcomes in high-risk pregnancies.

Main Methods:

• The ASpirin for evidence-based PREeclampsia prevention (ASPRE) trial is a double-blinded, placebo-controlled, randomized controlled trial (RCT).
• Women at high risk for preterm PE are identified through a screening program at 11-13 weeks gestation.
• Eligible women receive either low-dose aspirin or a placebo from 11-13 weeks gestation until delivery.

Main Results:

• The ASPRE trial protocol (V.6, January 2016) outlines the study methodology.
• As of April 2016, 26,670 women were screened, and 1,760 were recruited into the RCT.
• The study aims to provide evidence-based prevention for pre-eclampsia.

Conclusions:

• The ASPRE trial is designed to provide robust evidence on the prophylactic use of low-dose aspirin for pre-eclampsia prevention.
• Findings from this RCT will inform clinical guidelines for managing high-risk pregnancies.
• The study addresses a critical need for effective interventions to reduce the burden of pre-eclampsia.