- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02823743
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
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
|
Daily medication
Other Names:
|
Placebo Comparator: Placebo
Placebo pill orally daily from gestational week 7-35
|
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
Collaborators
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
Additional Relevant MeSH Terms
- Pregnancy Complications
- Abortion, Spontaneous
- Abortion, Habitual
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
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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