RECAB-ASA; Treatment of Recurrent Abortion With Aspirin (RECAB-ASA)

July 5, 2016 updated by: Annika Strandell, Göteborg University

Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial

The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy is detected on transvaginal ultrasound (around gestational week 6+) and continues to week 35/36. The study is a single center, randomized, placebo-controlled, double blind and stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are enrolled, 200 in each arm aspirin / placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 37 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • recurrent abortion (≤ 3 consecutive abortions in first trimester)
  • unknown etiology after work-up
  • willingness to be randomized

Exclusion Criteria:

  • previous participation in the study
  • known cause of recurrent abortion, requiring specific management
  • age ≥ 40
  • BMI above 35
  • IVF pregnancy if the reason for IVF was recurrent spontaneous abortion
  • ongoing treatment with aspirin for other reason
  • Sjoegren syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose aspirin
75 mg aspirin orally daily from gestational week 7-35
Drug: Aspirin
Daily medication
Other Names:
  • ASA
Placebo Comparator: Placebo
Placebo pill orally daily from gestational week 7-35
Drug: Placebo
Daily intake

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth
Time Frame: delivery
delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Spontaneous abortion
Time Frame: up to 22 weeks
up to 22 weeks
Vaginal bleeding
Time Frame: up to 42 weeks
up to 42 weeks
Premature delivery
Time Frame: At delivery
At delivery
intrauterine growth retardation, measured by ultrasound as percentage deviation
Time Frame: up to 42 weeks
up to 42 weeks
Preeclampsia
Time Frame: up to 42 weeks
up to 42 weeks
Pregnancy induced hypertension
Time Frame: up to 42 weeks
up to 42 weeks
Placenta praevia
Time Frame: up to 42 weeks
up to 42 weeks
Perinatal mortality
Time Frame: Third trimester and 28 days after delivery
Third trimester and 28 days after delivery
Perinatal morbidity
Time Frame: 28 days after delivery
28 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Vastra Gotaland Region

Investigators

  • Principal Investigator: Annika Strandell, Ass.prof., Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 28, 2016

First Submitted That Met QC Criteria

July 5, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 5, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGR-2170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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