Clinical Trial: Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Randomised Placebo-controlled Trial of Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage

Brief Summary:

Miscarriage is the most common complication of pregnancy. As many as 15-25% of pregnancies end in miscarriage, and the number of miscarriages in England is estimated to be approximately 125,000 per year. Miscarriage often brings not only physical pain, bleeding and risks of infection, but also psychological impacts on women and their families. This study will focus on women whose pregnancy sac remains inside the womb (known as a missed miscarriage) and opt for medical management of their miscarriage up to 13+6 weeks of pregnancy. NICE currently recommends that a drug called misoprostol (a vaginal pessary or oral tablet that makes the womb contract) should be used in the medical treatment of miscarriage. However, there is evidence to suggest that combining this drug with mifepristone (an oral tablet that reduces pregnancy hormones) may be more effective in treating miscarriage. Therefore, to test this in a clinical trial, participants will be allocated at random to receive either mifepristone followed by misoprostol, or a dummy drug (placebo) followed by misoprostol. Neither the participants nor the researchers will know what allocation is decided, which is necessary to test the treatments fairly. The main outcome of interest will be whether miscarriage is complete within 7 days of starting the tablets. If miscarriage is not complete then further treatment (more tablets or surgery) will be offered. A number of other key outcomes, such as the need for an operation, will also be assessed. We will also study the views and experience of the participants regarding the tablet treatment.

We anticipate that 710 women will be required to take part in the study to answer this question with confidence. We estimate that we would be able to recruit this many women in two years.


Detailed Summary:
Sponsor: University of Birmingham

Current Primary Outcome: Failure to spontaneously pass the gestational sac within 7 days after start of the medical treatment [ Time Frame: Within 7 days after start of medical treatment ]

To test the hypothesis that treatment with mifepristone plus misoprostol is superior to misoprostol alone for the resolution of miscarriage within 7 days by at least 10% in women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need for further doses of misoprostol. [ Time Frame: After initial 800mcg dose of misoprostol at day 2 until discharge ]
    Need for further doses of misoprostol.
  • Time from randomisation to passage of gestational sac. [ Time Frame: Time from randomisation to passage of gestational sac; assessed up to 8 weeks ]
    Time from randomisation to passage of gestational sac.
  • Time from active treatment commencement to passage of gestational sac. [ Time Frame: Time from active treatment commencement to passage of gestational sac; assessed up to 8 weeks ]
    Time from active treatment (mifepristone or misoprostol) commencement to passage of gestational sac.
  • Expulsion of the gestational sac without the need for surgery. [ Time Frame: From randomisation until discharge; assessed up to 8 weeks ]
    Expulsion of the gestational sac without the need for surgery.
  • Unplanned surgery [ Time Frame: From randomisation until discharge; assessed up to 8 weeks ]
    Unplanned surgery
  • Patient satisfaction. [ Time Frame: Within 6 weeks of discharge ]
    Patient satisfaction questionnaire (using validated CSQ-8 questionnaire)
  • Patient quality of life. [ Time Frame: Completion at randomisation, 6-7 days after start of medical treatment at clinical review and ultrasound scan assessment and upon discharge. Completion of all patient quality of life assessments up to 8 weeks post-randomisation ]
    EQ-5D-5L questionnaire
  • Blood transfusion. [ Time Frame: From randomisation until discharge; assessed up to 8 weeks ]
    Did the patient require a blood transfusion.
  • Days of bleeding [ Time Frame: From randomisation until discharge; assessed up to 8 weeks ]
    Number of days of bleeding.
  • Infection requiring outpatient antibiotics treatment. [ Time Frame: From randomisation until discharge; assessed up to 8 weeks ]
    Infection requiring outpatient antibiotics treatment.
  • Infection requiring inpatient treatment. [ Time Frame: From randomisation until discharge; assessed up to 8 weeks ]
    Infection requiring inpatient treatment.
  • Negative pregnancy test result 21 days after start of medical treatment. [ Time Frame: 21 days after start of medical treatment ]
    Negative pregnancy test result 21 days after start of medical treatment.
  • Time from start of medical treatment to discharge. [ Time Frame: Time from start of medical treatment to discharge; assessed up to 8 weeks ]
    Time from start of medical treatment to discharge.
  • Side effects. [ Time Frame: From randomisation until discharge; assessed up to 8 weeks ]
    Side effects.
  • Death or serious complications. [ Time Frame: From randomisation until discharge; assessed up to 8 weeks ]
    Death or serious complications.


Original Secondary Outcome: Same as current

Information By: University of Birmingham

Dates:
Date Received: February 10, 2017
Date Started: August 2017
Date Completion: August 2019
Last Updated: February 22, 2017
Last Verified: February 2017