A Phase 3 interventional study of Mifepristone, Oral, 200 Mg and Placebo Oral Tablet in Missed Miscarriage, sponsored by University of Birmingham. Completed at 28 sites in United Kingdom. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-09.
Sponsored by University of Birmingham · Phase 3, Interventional, and Treatment
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 randomisation. 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.
Aim: To investigate the clinical and cost-effectiveness of MifeMiso combination (mifepristone and misoprostol) versus misoprostol alone in the management of missed miscarriage.
Primary clinical objective: To test the hypothesis that treatment with mifepristone plus misoprostol is superior to misoprostol alone for the resolution of miscarriage within 7 days in women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy.
Key secondary objective:To test the hypothesis that the addition of mifepristone reduces the need for surgical intervention to resolve the miscarriage.
Other secondary objectives:
Economic objectives: To assess the cost-effectiveness of the combination of mifepristone and misoprostol in the medical management of missed miscarriage based on an outcome of additional cost per additional successfully managed miscarriage and additional cost per additional quality-adjusted life-year (QALY). Using a model-based economic evaluation we will further explore the cost-effectiveness of the medical management of missed miscarriage, as explored in the proposed trial, with alternative management strategies, such as surgical and expectant, based on available secondary sources.
Mixed-method evaluation objectives: To explore the satisfaction of patients who complete the trial protocol. The results of the satisfaction survey (CSQ-8) will act as a sampling frame to conduct semi-structured interviews to further investigate patient experiences and satisfaction with medical management of missed miscarriage.
24 studies on the registry are indexed under Abortion, Incomplete; 5 are open to participants now.
This study's enrollment of 711 is above the median of 311 across 21 interventional studies indexed under Abortion, Incomplete.
Browse Abortion, Incomplete studies →University of Birmingham is the lead sponsor of 182 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A single dose of oral mifepristone 200mg, followed by a single dose of vaginal, oral or sublingual misoprostol 800mcg 2 days later
Drug: Mifepristone, Oral, 200 Mg
Oral placebo tablet followed by a single dose of vaginal, oral or sublingual misoprostol 800mcg 2 days later.
Drug: Placebo Oral Tablet
The Investigational Medicinal Product (IMP) is a single dose of 200mg mifepristone to be taken orally after confirmation of missed miscarriage by pelvic ultrasound scan.
Also known as: Mifegyne
The placebo will be an oral tablet in the same form as the IMP, and identical in appearance.
Failure to spontaneously pass the gestational sac within 7 days after randomisation
To test the hypothesis that treatment with mifepristone plus misoprostol is superior to misoprostol alone for the resolution of miscarriage within 7 days in women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy.
Time frame: Within 7 days after randomisation
Surgical intervention to resolve the miscarriage (collected up to discharge from EPU care)
Surgical intervention to resolve the miscarriage
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Surgical intervention to resolve the miscarriage up to and including day 7 post-randomisation
Surgical intervention to resolve the miscarriage
Time frame: From randomisation until day 7 post-randomisation
Surgical intervention to resolve the miscarriage after day 7 post-randomisation to discharge from EPU care
Surgical intervention to resolve the miscarriage
Time frame: From day 8 post-randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Need for further doses of misoprostol up to day 7 post-randomisation
Need for further doses of misoprostol up to day 7 post-randomisation
Time frame: After initial 800mcg dose of misoprostol at day 2 until day 7 post-randomisation
Need for further doses of misoprostol up to discharge from EPU care
Need for further doses of misoprostol up to discharge from EPU care
Time frame: After initial 800mcg dose of misoprostol at day 2 until discharge from EPU care; assessed up to approximately 8 weeks
Overall patient satisfaction score (measured using the CSQ-8 questionnaire and collected upon discharge from EPU care).
Overall patient satisfaction score (measured using the CSQ-8 questionnaire and collected upon discharge from EPU care).
Time frame: Within 6 weeks of discharge from EPU care
Patient quality of life (Index value and overall health status measured using the EQ-5D-5L questionnaire
Patient quality of life (Index value and overall health status measured using the EQ-5D-5L questionnaire and collected on date of randomisation, day 6-7 post-randomisation or day of follow-up USS if different to day 6-7 and day 21 +/- 2 days post-randomisation. If a woman obtains an initial positive pregnancy test result at day 21 +/- 2 days post-randomisation then a further EQ-5D-5L questionnaire is collected upon discharge from EPU care).
Time frame: Completion on date of randomisation, day 6-7 post-randomisation or day of follow-up USS if different to day 6-7 and day 21 +/- 2 days post-randomisation. Completion of all patient quality of life assessments up to approximately 8 weeks post-randomisation
Duration of bleeding reported by woman (days). (collected up to discharge from EPU care)
Duration of bleeding reported by woman (days). (collected up to discharge from EPU care)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Diagnosis of infection associated with miscarriage requiring outpatient antibiotic treatment (collected up to discharge from EPU care)
Diagnosis of infection associated with miscarriage requiring outpatient antibiotic treatment (collected up to discharge from EPU care)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Diagnosis of infection associated with miscarriage requiring inpatient antibiotic treatment (collected up to discharge from EPU care)
Diagnosis of infection associated with miscarriage requiring inpatient antibiotic treatment (collected up to discharge from EPU care)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Negative pregnancy test result 21 days (± 2 days) after randomisation.
Negative pregnancy test result 21 days (± 2 days) after randomisation.
Time frame: 21 days (± 2 days) after randomisation.
Time from randomisation to discharge from EPU care (described using summary statistics only)
Time from randomisation to discharge from EPU care.
Time frame: Time from randomisation to discharge from EPU care; assessed up to approximately 8 weeks
Blood transfusion required (collected up to discharge from EPU care)
Blood transfusion required (collected up to discharge from EPU care)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Side effects (collected up to discharge from EPU care)
Side effects (collected up to discharge from EPU care)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Death (collected up to discharge from EPU care)
Death (collected up to discharge from EPU care)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Any serious complications (collected up to discharge from EPU care)
Any serious complications (collected up to discharge from EPU care)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Outpatient or emergency visits
Number of outpatient or emergency visits
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Inpatient admissions (nights in hospital)
Number of inpatient admissions (nights in hospital)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Plan to share: No
Ran from Sep 2017 to primary completion in Jan 2020, 27 months.
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Studies of the drug tested here: Mifepristone