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TerminatedPhase 3Phase 4ACTRN12612001254886

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?

Sponsor

Nandini Somanathan

Enrollment

500 participants

Start Date

Feb 26, 2015

Study Type

Interventional

Conditions

First trimester miscarriage

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.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Inclusion Criteria5

  • 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:
  • Early embryonic demise = Mean sac diameter (MSD) >20mm with nil internal structures
  • Anembryonic pregnancy = empty gestational sac of at least 12mm and no growth over 3 or more days
  • Early fetal demise = fetus crown rump length (CRL) at least 6mm with nil fetal heart beat on transvaginal USS
  • Incomplete miscarriage = mixed echogenicity within endometrial cavity +/- disordered gestational sac

Exclusion Criteria4

  • severe haemorrhage or pain
  • pyrexia
  • allergy or contraindication to misoprostol or mifepristone
  • current anticoagulation

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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 4

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

Locations(2)

John Hunter Hospital - New Lambton

NSW, Australia

The Maitland Hospital - Maitland

NSW, Australia

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ACTRN12612001254886