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

Among women with first trimester miscarriage, is the combination of mifepristone plus misoprostol superior to misoprostol alone for reducing the need for surgical uterine evacuation and repeat doses of misoprostol?

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612001254886

Enrollment

Registered

2012-11-28

Start date

2015-02-26

Completion date

2017-04-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We are doing this study to determine the most effective medication for treating women who have a miscarriage during the first three months of their pregnancy. Our clinic offers different treatment options for managing miscarriage. The first involves a single medication (Misoprostol) and the second, two separate medications (Misoprostol and Mifepristone). At present there is no evidence to show that one works better than the other. Currently, the treatment you are given depends on the women’s choice and which one the treating doctor feels will be best for the patient. Currently, it is not clear if one treatment is better than the other . We hope that this study will if adding mifepristone to the treatment improves its effectiveness so that we can better manage miscarriage.

Interventions

Mifepristone plus misoprostol. 200mg oral mifepristone. Participants take the misoprostol tablets home with them to take 2 days after the mifepristone at an oral dose of 400mcg followed by a further 400mcg 3 hrs later

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

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

Outcome results