Missed MiscarriagePhase 3MifeMisoNCT03065660
Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage
A Phase 3 study testing Mifepristone, Oral, 200 Mg in people with Missed Miscarriage, run by University of Birmingham at 28 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Missed Miscarriage
- What is being tested?
- Mifepristone, Oral, 200 Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 711 participants
- Where
- 28 sitesUnited Kingdom
- Study dates
- 20 Sep 2017to 9 Jan 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy that choose to have medical management of miscarriage.
- Age 16 years and over
- Willing and able to give informed consent.
Who cannot join
- Women opting for alternative methods of miscarriage management (expectant or surgical)
- Diagnosis of incomplete miscarriage.
- Life threatening bleeding.
- Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria.
- Participation in any other blinded, placebo-controlled trials of investigational medicinal products in pregnancy.
- Previous participation in the MifeMiso trial
- Woman not able to attend for day 6-7 ultrasound scan
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
United Kingdom28 sites
Birmingham Heartlands Hospital
Birmingham
Birmingham Women's Hospital
Birmingham
Southmead Hospital
Bristol
St Michael's Hospital
Bristol
Burnley General Hospital
Burnley
University Hospital Coventry
Coventry
Royal Infirmary of Edinburgh
Edinburgh
Epsom Hospital
Epsom
St Helier Hospital
Epsom
Glasgow Royal Infirmary
Glasgow
Queen Elizabeth University Hospital
Glasgow
Liverpool Women's Hospital
Liverpool
Chelsea and Westminster Hospital
London
Kings College Hospital
London
Newham University Hospital
London
Royal London Hospital
London
St Thomas' Hospital
London
University College Hospital London
London
West Middlesex Hospital
London
Whipps Cross University Hospital
London
Royal Victoria Infirmary
Newcastle
Queen's Medical Centre
Nottingham
Queen Alexandra Hospital
Portsmouth
Princess Anne Hospital
Southampton
Sunderland Royal Hospital
Sunderland
Princess of Wales Hospital
Swansea
Singleton Hospital
Swansea
Princess Royal Hospital
Telford
About this study
Official title: A Randomised Placebo-controlled Trial of Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage
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.
Read the detailed description
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:
- To evaluate if the addition of mifepristone reduces the need for further doses of misoprostol.
- To evaluate if the addition of mifepristone improves other clinical outcomes including surgical intervention up to and including 7 days post-randomisation and after 7 days post-randomisation, duration of bleeding, infection, negative pregnancy test at 21 days post-randomisation, time from randomisation to discharge from EPU care, side effects and complications.
- To evaluate if the addition of mifepristone improves patient satisfaction
- To assess the cost-effectiveness of the combination of mifepristone and misoprostol in the medical management of missed miscarriage.
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.
- Conditions
- Missed Miscarriage
- Being tested
- Mifepristone, Oral, 200 Mg, Placebo Oral Tablet
- Keywords
- Missed miscarriage, Mifepristone, Misoprostol, Medical management
- Medical subject headings
- Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone, Oral, 200 MgDrug
Also called Mifegyne
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.
Placebo Oral TabletDrug
The placebo will be an oral tablet in the same form as the IMP, and identical in appearance.
| Study group | Role | What they receive |
|---|---|---|
| Mifepristone | Active comparator | A single dose of oral mifepristone 200mg, followed by a single dose of vaginal, oral or sublingual misoprostol 800mcg 2 days later Receives: Drug: Mifepristone, Oral, 200 Mg |
| Placebo | Placebo comparator | Oral placebo tablet followed by a single dose of vaginal, oral or sublingual misoprostol 800mcg 2 days later. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 7 days after randomisation
Secondary outcomes (16)
Surgical intervention to resolve the miscarriage (collected up to discharge from EPU care)
Surgical intervention to resolve the miscarriage
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study start20 Sep 2017
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised, parallel group, double-blind, placebo-controlled multicentre study, with health economic and mixed-methods evaluation.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Birmingham Women's NHS Foundation Trust, Royal Infirmary of Edinburgh, Royal Victoria Infirmary, City Hospitals Sunderland NHS Foundation Trust, Liverpool Women's NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Barts & The London NHS Trust, Queen's Medical Center, Heart of England NHS Trust, University Hospitals Coventry and Warwickshire NHS Trust, Oxford University Hospitals NHS Trust, St Mary's Hospital, London, University College London Hospitals, University Hospital Southampton NHS Foundation Trust, King's College Hospital NHS Trust, University of Edinburgh, University of Nottingham, Queen Mary University of London, University of Warwick, University of Southampton
- Responsible party
- Sponsor
- Investigators
- Arri Coomarasamy, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065660
- Sponsor's protocol ID
- RG_16-076
- Other IDs
- 15/160/02, 2016-005097-35, 2016
- Acronym
- MifeMiso
- Status last verified
- Apr 2020
- First submitted
- 10 Feb 2017
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo-controlled Trial of Mifepristone and Misoprostol Versus Misoprostol Alone in the Medical Management of Missed Miscarriage
- ClinicalTrials.gov ID
- NCT03065660
- Acronym / sponsor ID
- MifeMiso / RG_16-076
- Conditions
- Missed Miscarriage
- Keywords
- Missed miscarriage, Mifepristone, Misoprostol, Medical management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Birmingham Women's NHS Foundation Trust, Royal Infirmary of Edinburgh, Royal Victoria Infirmary, City Hospitals Sunderland NHS Foundation Trust, Liverpool Women's NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Barts & The London NHS Trust, Queen's Medical Center, Heart of England NHS Trust, University Hospitals Coventry and Warwickshire NHS Trust, Oxford University Hospitals NHS Trust, St Mary's Hospital, London, University College London Hospitals, University Hospital Southampton NHS Foundation Trust, King's College Hospital NHS Trust, University of Edinburgh, University of Nottingham, Queen Mary University of London, University of Warwick, University of Southampton
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- To evaluate if the addition of mifepristone reduces the need for further doses of misoprostol.
- To evaluate if the addition of mifepristone improves other clinical outcomes including surgical intervention up to and including 7 days post-randomisation and after 7 days post-randomisation, duration of bleeding, infection, negative pregnancy test at 21 days post-randomisation, time from randomisation to discharge from EPU care, side effects and complications.
- To evaluate if the addition of mifepristone improves patient satisfaction
- To assess the cost-effectiveness of the combination of mifepristone and misoprostol in the medical management of missed miscarriage.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A randomised, parallel group, double-blind, placebo-controlled multicentre study, with health economic and mixed-methods evaluation.
| Arm | Type | Receives |
|---|---|---|
| Mifepristone | Active comparator | Drug: Mifepristone, Oral, 200 MgA single dose of oral mifepristone 200mg, followed by a single dose of vaginal, oral or sublingual misoprostol 800mcg 2 days later |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletOral placebo tablet followed by a single dose of vaginal, oral or sublingual misoprostol 800mcg 2 days later. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy that choose to have medical management of miscarriage.
- Age 16 years and over
- Willing and able to give informed consent.
Key exclusion criteria (7 listed)
- Women opting for alternative methods of miscarriage management (expectant or surgical)
- Diagnosis of incomplete miscarriage.
- Life threatening bleeding.
- Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria.
- Participation in any other blinded, placebo-controlled trials of investigational medicinal products in pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone, Oral, 200 MgAlso: MifegyneThe Investigational Medicinal Product (IMP) is a single dose of 200mg mifepristone to be taken orally after confirmation of missed miscarriage by pelvic ultrasound scan. | Drug | Mifepristone |
| Placebo Oral TabletThe placebo will be an oral tablet in the same form as the IMP, and identical in appearance. | Drug | Placebo |
Primary outcome
Failure to spontaneously pass the gestational sac within 7 days after randomisation
Time frame: 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.
16 secondary outcomes
Surgical intervention to resolve the miscarriage (collected up to discharge from EPU care)
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
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
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
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
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).
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
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)
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)
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)
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.
Time frame: 21 days (± 2 days) after randomisation.
Time from randomisation to discharge from EPU care (described using summary statistics only)
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)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
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)
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)
Time frame: From randomisation until discharge from EPU care; assessed up to approximately 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arri Coomarasamy principal investigator
University of Birmingham
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mifepristone, Oral, 200 Mg in people with Missed Miscarriage, run by University of Birmingham at 28 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure to spontaneously pass the gestational sac within 7 days after randomisation (time frame: Within 7 days after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.