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Early Prevention of Preeclampsia Study (EPAPP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Anthony Odibo, Washington University Identifier:
First received: March 1, 2012
Last updated: June 9, 2014
Last verified: June 2014
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.

Condition Intervention
Drug: Aspirin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Prediction and Aspirin for Prevention of Preeclampsia

Resource links provided by NLM:

Further study details as provided by Washington University School of Medicine:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 684
Study Start Date: March 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aspirin
Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Drug: Aspirin
Placebo Comparator: placebo
placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
Drug: placebo

Detailed 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01547390

United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Anthony Odibo, MD, MSCE Washington University School of Medicine
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anthony Odibo, Associate Professor, Washington University Identifier: NCT01547390     History of Changes
Other Study ID Numbers: 201112007
Study First Received: March 1, 2012
Last Updated: June 9, 2014

Keywords provided by Washington University School of Medicine:

Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced
Pregnancy Complications
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on May 23, 2017