M&M Trial
Completed
- Conditions
- early pregnancy failure, miscarriage, missed abortion, medical treatment, mifepriston, misoprostol, miskraam, niet-vitale zwangerschap, medicamenteuze behandeling
- Registration Number
- NL-OMON21883
- Lead Sponsor
- Radboudumc791 Verloskunde & Gynaecologie StafafdelingPostbus 9101, 6500 HB Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Early pregnancy failure, 6-14 weeks postmenstrual
o Crown-rump length ≥ 6mm and no cardiac activity OR
Exclusion Criteria
Interaction between study-medication and other medicine
o Medicinal products and other forms that are CYP3A4 substrates: ketoconazole, itraconazole, erythromycin, rifampicin, dexamethasone, St. John's Wort, certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) and grapefruit juice
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete (success) or incomplete (failure) evacuation will be determined using transvaginal ultrasonography six to nine days after medical treatment. An endometrial thickness <15mm (maximum anterior-posterior diameter) and no evidence of retained products of conception using only the allocated therapy is considered as complete evacuation.
- Secondary Outcome Measures
Name Time Method Patient satisfaction with treatment will be measured using a standard, validated questionnaire; the Client Satisfaction Questionnaire (CSQ-8) will be filled in four weeks after treatment.<br /><br>Quality of life will be measured at baseline, two days and four weeks after treatment using standard, validated questionnaires such as EuroQOL and Short Form 36. <br><br /><br /><br>Patients will receive a registration form to document possible side effects. The treating gynaecologist will document these side effects and complications using the case report form (CRF).