A trial to test if using a combination of drugs (mifepristone followed by misoprostol) is better than giving misoprostol alone to more quickly resolve a miscarriage.
- Conditions
- Missed miscarriage up to 13+6 weeks gestation.Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2016-005097-35-GB
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 710
1. Women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13+6 weeks of pregnancy.
2. Age 16 years and over.
3. Willing and able to give informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 690
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Women opting for alternative methods of miscarriage management (expectant or surgical)
2. Diagnosis of incomplete miscarriage.
3. Life threatening bleeding.
4. 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.
5. Participation in any other blinded, placebo-controlled trials of investigational medicinal products in pregnancy.
6. Previous participation in the MifeMiso trial
7. Woman not able to attend for day 6-7 ultrasound scan
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method