NCT01547390

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2015

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

May 14, 2018

Completed
Last Updated

June 29, 2018

Status Verified

May 1, 2018

Enrollment Period

3.4 years

First QC Date

March 1, 2012

Results QC Date

January 29, 2018

Last Update Submit

May 29, 2018

Conditions

Preeclampsia

Keywords

preeclampsiaAspirin

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Preeclampsia

    Preeclampsia diagnosed per ACOG criteria: Blood pressure greater than 140/90 on 2 occasions 6 hrs apart and significant proteinuria (greater than 300mg in 24hrs).

    within 3 months prior to delivery

Secondary Outcomes (1)

  • Number of Participants With IUGR, Early Preeclampsia, Severe Preeclampsia, Gestational Hypertension, Preterm Birth, Stillbirth, Placental Abruption, Antepartum Hemorrhage, Neonatal Death, NICU Admission, Miscarriage

    within 3 months of delivery

Study Arms (2)

Aspirin

EXPERIMENTAL

Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Drug: Aspirin

placebo

PLACEBO COMPARATOR

placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first

Drug: placebo

Interventions

AspirinDRUG
Aspirin
placeboDRUG
placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Multiple gestations,
  • fetal aneuploidy
  • major fetal structural anomaly
  • bleeding disorder
  • allergy to aspirin
  • women already on aspirin or heparin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 25914193DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Limitations and Caveats

Study terminated due to poor enrollment after Aspirin was recommended by the US Preventive Task Force for the Prevention of Preeclampsia.

Results Point of Contact

Title
Dr. Anthony Odibo
Organization
University of South Florida
aodibo@health.usf.edu
813-259-0828

Study Officials

  • Anthony Odibo, MD, MSCE

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 7, 2012

Study Start

March 1, 2012

Primary Completion

July 20, 2015

Study Completion

July 20, 2015

Last Updated

June 29, 2018

Results First Posted

May 14, 2018

Record last verified: 2018-05

Locations

US(1)