Overview

This trial is active, not recruiting.

Condition preeclampsia
Treatments aspirin, placebo
Sponsor Washington University School of Medicine
Start date March 2012
End date June 2015
Trial size 684 participants
Trial identifier NCT01547390, 201112007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
aspirin
(Placebo Comparator)
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
placebo

Primary Outcomes

Measure
Preeclampsia (diagnosed per ACOG criteria)
time frame: within 3 months of delivery

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants of any age.

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.

Additional Information

Official title Early Prediction and Aspirin for Prevention of Preeclampsia
Principal investigator Anthony Odibo, MD, MSCE
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.