Mifipristone and misoprostol compared to misoprostol alone in the treatment of first trimester miscarriage. A randomised control trial.

Phase 3

• Conditions: First trimester miscarriage; Reproductive Health and Childbirth - Abortion

• Registration Number: ACTRN12612001254886
• Lead Sponsor: andini Somanathan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-28
• Study Completion: 2017-04-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: Female
• Target Recruitment: 53

Inclusion Criteria

Patients will be included who have a positive serum beta hCG and are less than 13 weeks pregnant, as determined by the size of their gestational sac or crown rump length on ultrasound. Definitions for types of miscarriage are:
1) Early embryonic demise = Mean sac diameter (MSD) >20mm with nil internal structures
2) Anembryonic pregnancy = empty gestational sac of at least 12mm and no growth over 3 or more days
3) Early fetal demise = fetus crown rump length (CRL) at least 6mm with nil fetal heart beat on transvaginal USS
4) Incomplete miscarriage = mixed echogenicity within endometrial cavity +/- disordered gestational sac

Exclusion Criteria

1) severe haemorrhage or pain
2) pyrexia
3) allergy or contraindication to misoprostol or mifepristone
4) current anticoagulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified