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Early Prevention of Preeclampsia Study (EPAPP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01547390
First received: March 1, 2012
Last updated: June 2, 2017
Last verified: June 2017
March 1, 2012
June 2, 2017
March 2012
July 20, 2015   (Final data collection date for primary outcome measure)
Preeclampsia (diagnosed per ACOG criteria) [ Time Frame: within 3 months of delivery ]
Preeclampsia (diagnosed per ACOG criteria)
Complete list of historical versions of study NCT01547390 on ClinicalTrials.gov Archive Site
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 ]
Intrauterine growth restriction, early preeclampsia, severe preeclampsia, gestational hypertension, preterm birth, stillbirth, placental abruption, antepartum hemorrhage, neonatal death, NICU admission, miscarriage.
Not Provided
Not Provided
 
Early Prevention of Preeclampsia Study
Early Prediction and Aspirin for Prevention of Preeclampsia
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Preeclampsia
  • Drug: Aspirin
  • Drug: placebo
  • Experimental: Aspirin
    Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
    Intervention: Drug: Aspirin
  • Placebo Comparator: placebo
    placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
    Intervention: Drug: placebo
Odibo AO, Goetzinger KR, Odibo L, Tuuli MG. Early prediction and aspirin for prevention of pre-eclampsia (EPAPP) study: a randomized controlled trial. Ultrasound Obstet Gynecol. 2015 Oct;46(4):414-8. doi: 10.1002/uog.14889. Epub 2015 Aug 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
July 20, 2015
July 20, 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01547390
201112007
Yes
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Anthony Odibo, MD, MSCE Washington University School of Medicine
Washington University School of Medicine
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP