RECAB-ASA; Treatment of Recurrent Abortion With Aspirin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Abortion, Habitual

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Low dose aspirin

75 mg aspirin orally daily from gestational week 7-35

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

Daily medication

Placebo

Placebo pill orally daily from gestational week 7-35

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily intake

Interventions

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Aspirin

Daily medication

Intervention Type DRUG

Placebo

Daily intake

Intervention Type DRUG

Other Intervention Names

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ASA

Eligibility Criteria

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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

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No