Early Prevention of Preeclampsia Study (EPAPP)

The Washington University

Status: Terminated

Conditions: Preeclampsia

Treatments: Drug: Aspirin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01547390

201112007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 104 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton pregnancy undergoing ultrasound examination at 9 0/7 - 14 6/7 weeks
• any one or more factors identified as high risk from the identified risk factors: Chronic hypertension, prepregnancy diabetes mellitus, previous preeclampsia, obesity (BMI >30), bilateral uterine artery notches preeclampsia risk score greater than 6, low PAPP-A ( < 0.52 MoM)

Exclusion criteria

• Multiple gestations,
• fetal aneuploidy
• major fetal structural anomaly
• bleeding disorder
• allergy to aspirin
• women already on aspirin or heparin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

104 participants in 2 patient groups, including a placebo group

Aspirin

Experimental group

Description:

Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Treatment:

Drug: Aspirin

placebo

Placebo Comparator group

Description:

placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Treatment:

Drug: placebo