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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

MedlinePlus related topics: High Blood Pressure

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


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.

Eligibility


Genders 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
St. 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

No publications provided


Responsible Party:	Anthony Odibo, Associate Professor, Washington University
ClinicalTrials.gov Identifier:	NCT01547390 History of Changes
Other Study ID Numbers:	201112007
Study First Received:	March 1, 2012
Last Updated:	June 9, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:


preeclampsia Aspirin

Additional relevant MeSH terms:


Pre-Eclampsia Hypertension, Pregnancy-Induced Pregnancy Complications Aspirin Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antipyretics Antirheumatic Agents Cardiovascular Agents Central Nervous System Agents	Cyclooxygenase Inhibitors Enzyme Inhibitors Fibrin Modulating Agents Fibrinolytic Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

Early Prevention of Preeclampsia Study (EPAPP)