Early Prevention of Preeclampsia Study (EPAPP)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Early Prediction and Aspirin for Prevention of Preeclampsia|
- Preeclampsia (diagnosed per ACOG criteria) [ Time Frame: within 3 months of delivery ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Placebo Comparator: placebo
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
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.
|United States, Missouri|
|St. Louis, Missouri, United States, 63110|
|Contact: Anthony Odibo, MD, MSCE 314-362-8895|
|Principal Investigator:||Anthony Odibo, MD, MSCE||Washington University in St. Louis|