Early Prevention of Preeclampsia Study - Full Text View

Purpose

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
Preeclampsia	Drug: Aspirin Drug: placebo


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

Resource links provided by NLM:

Genetics Home Reference related topics: preeclampsia

Drug Information available for: Aspirin

Genetic and Rare Diseases Information Center resources: Eclampsia

U.S. FDA Resources

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 ]


Enrollment:	104
Study Start Date:	March 2012
Study Completion Date:	July 20, 2015
Primary Completion Date:	July 20, 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.

Eligibility


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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01547390 History of Changes
Other Study ID Numbers:	201112007
Study First Received:	March 1, 2012
Last Updated:	June 2, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017

Early Prevention of Preeclampsia Study (EPAPP)