Clinical Trial: Early Prevention of Preeclampsia Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Early Prediction and Aspirin for Prevention of Preeclampsia

Brief Summary: This is a randomized controlled trial to estimate the efficacy of low dose aspirin for preventing preeclampsia in women identified as high risk. The investigators hypothesize that the risk of preeclampsia in women identified by a first trimester multiparameter predictive model to be at high risk will be significantly reduced by initiating low dose aspirin early in pregnancy.

Detailed Summary:

This will be a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in women identified in the first trimester to be at high risk. We will also obtain maternal blood, cord blood and placenta specimen for basic science studies to attempt to dissect biological mechanisms of aspirin effects. In addition we will conduct a cost-benefit analysis to determine the cost effectiveness of screening and using aspirin prophylaxis for screen positive women.

Rationale for Design: The randomized control trial is the 'gold standard' of research design. Other designs such as case-control, retrospective cohort and prospective cohort are limited by potential bias and confounding. Randomly assigning subjects to different interventions minimizes selection bias. The random assignment also results in groups that are likely to be similar with regards to important confounding variables. This minimizes confounding by both measured and unmeasured factors. While random allocation does not guarantee the groups will be identical, it does ensure that any differences between them are due to chance alone. Finally, randomization produces groups that are random samples of the population. This permits use of standard statistical tests that are based on probability theory.

Sponsor: Washington University School of Medicine

Current Primary Outcome: Preeclampsia (diagnosed per ACOG criteria) [ Time Frame: within 3 months of delivery ]

Original Primary Outcome: Preeclampsia (diagnosed per ACOG criteria)

Current Secondary Outcome: Intrauterine growth restriction, early preeclampsia, severe preeclampsia, gestational hypertension, preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage. [ Time Frame: within 3 months of delivery ]

Original Secondary Outcome: Intrauterine growth restriction, early preeclampsia, severe preeclampsia, gestational hypertension, preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage.

Information By: Washington University School of Medicine

Dates:
Date Received: March 1, 2012
Date Started: March 2012
Date Completion: September 2015
Last Updated: June 9, 2014
Last Verified: June 2014