Clinical Trial: RECAB-ASA; Treatment of Recurrent Abortion With Aspirin
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial
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 Summary:
Sponsor: Göteborg University
Current Primary Outcome: Live birth [ Time Frame: delivery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Spontaneous abortion [ Time Frame: up to 22 weeks ]
- Vaginal bleeding [ Time Frame: up to 42 weeks ]
- Premature delivery [ Time Frame: At delivery ]
- intrauterine growth retardation, measured by ultrasound as percentage deviation [ Time Frame: up to 42 weeks ]
- Preeclampsia [ Time Frame: up to 42 weeks ]
- Pregnancy induced hypertension [ Time Frame: up to 42 weeks ]
- Placenta praevia [ Time Frame: up to 42 weeks ]
- Perinatal mortality [ Time Frame: Third trimester and 28 days after delivery ]
- Perinatal morbidity [ Time Frame: 28 days after delivery ]
Original Secondary Outcome: Same as current
Information By: Göteborg University
Dates:
Date Received: June 28, 2016
Date Started: March 2008
Date Completion:
Last Updated: July 5, 2016
Last Verified: July 2016