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