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Early Prevention of Preeclampsia Study (EPAPP)

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ClinicalTrials.gov Identifier: NCT01547390
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : May 14, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Preeclampsia Drug: Aspirin Drug: placebo Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Early Prediction and Aspirin for Prevention of Preeclampsia
Study Start Date : March 2012
Actual Primary Completion Date : July 20, 2015
Actual Study Completion Date : July 20, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Preeclampsia [ Time Frame: within 3 months of delivery ]
    Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occassions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs).


Secondary Outcome Measures :
  1. Secondary Outcomes as Described Below [ Time Frame: within 3 months of delivery ]

    Intrauterine growth restriction (IUGR) - estimated fetal weight less than 10th percentile early preeclampsia - preeclampsia delivered prior to 34 weeks severe preeclampsia - blood pressure greater then 160/110 gestational hypertension - hypertension without features of preeclampsia preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage.

    Statistical significance not reported due to the low recruitment and poor patient compliance.




Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01547390


Locations
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Anthony Odibo, MD, MSCE Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01547390     History of Changes
Other Study ID Numbers: 201112007
First Posted: March 7, 2012    Key Record Dates
Results First Posted: May 14, 2018
Last Update Posted: May 14, 2018
Last Verified: April 2018

Keywords provided by Washington University School of Medicine:
preeclampsia
Aspirin

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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