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Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia

NCT01352234 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2018-11-13

No results posted yet for this study

Summary

Placental insufficiency is the source of preeclampsia (PE) and intrauterine growth retardation (IUGR). Current data demonstrate a significant beneficial effect of prophylactic use of aspirin on the recurrence of placental insufficiency and its complications, mainly preeclampsia, when started early in pregnancy. However, there is a significant heterogeneity in medical practice in Canada and around the world in terms of the dose of aspirin used.

The objectives of this study are: 1) Evaluate whether a dose of 160 mg of aspirin is associated with greater improvement in placental function assessed by biochemistry (sFlt-1 and endoglin) and ultrasound (uterine artery Doppler) than a dose of 80 mg in women with a history of PE, 2) Assess whether the change is dependent on platelet aggregation measured by a test used in several Canadian centers (PFA-100).

Conditions

  • Pre-Eclampsia
  • Fetal Growth Retardation
  • Premature Birth
  • Placental Insufficiency

Interventions

DRUG

Acetylsalicylic Acid 160 mg

Capsule containing Acetylsalicylic Acid 160mg pill with lactose

DRUG

Acetylsalicylic Acid 80 mg

Capsule containing Acetylsalicylic Acid 80mg pill with lactose

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Emmanuel Bujold, MD, MSc · CHU de Quebec-Universite Laval

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-12-31
Completion
2015-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01352234 on ClinicalTrials.gov