RECAB-ASA; Treatment of Recurrent Abortion With Aspirin
- Registration Number
- NCT02823743
- Lead Sponsor
- Göteborg University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo pill orally daily from gestational week 7-35 Low dose aspirin Aspirin 75 mg aspirin orally daily from gestational week 7-35
- Primary Outcome Measures
Name Time Method Live birth delivery
- Secondary Outcome Measures
Name Time Method Spontaneous abortion up to 22 weeks Vaginal bleeding up to 42 weeks Premature delivery At delivery intrauterine growth retardation, measured by ultrasound as percentage deviation up to 42 weeks Preeclampsia up to 42 weeks Pregnancy induced hypertension up to 42 weeks Placenta praevia up to 42 weeks Perinatal mortality Third trimester and 28 days after delivery Perinatal morbidity 28 days after delivery