Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)
Overview
- Phase
- Phase 4
- Intervention
- Misoprostol
- Conditions
- Early Pregnancy Failure
- Sponsor
- Radboud University Medical Center
- Enrollment
- 342
- Locations
- 13
- Primary Endpoint
- Complete evacuation
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.
It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.
Detailed Description
This study will test the hypothesis that, in early pregnancy failure, the sequential combination of mifepristone with misoprostol is superior to the use of misoprostol alone in terms of complete evacuation of products of conception (primary outcome), patient satisfaction, complications, side effects and costs (secondary outcomes). The trial will be performed multi-centred (hospitals), prospectively, two-armed, randomized, double-blinded and placebo-controlled. Women with ultrasonographically confirmed early pregnancy failure (6-14 weeks postmenstrual), managed expectantly for at least one week, can be included. Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients will be randomized to oral mifepristone (600mg) or oral placebo (identical in appearance). The investigators aim to randomize 460 women in a 1:1 ratio, stratified by centre. After six weeks, the primary endpoint, complete or incomplete evacuation, will be determined
Investigators
Eligibility Criteria
Inclusion Criteria
- •Early pregnancy failure, 6-14 weeks postmenstrual with
- •a crown-rump length ≥ 6mm and no cardiac activity OR
- •a crown-rump length \<6mm and no fetal growth at least one week later OR
- •a gestational sac with absent embryonic pole for at least one week.
- •At least one week after diagnosis OR a discrepancy of at least one week between crown-rump length and calendar gestational age
- •Intra-uterine pregnancy
- •Women aged above 16 years
- •Hemodynamic stable patient
- •No signs of infection
- •No signs of incomplete abortion
Exclusion Criteria
- •Patient does not meet inclusion criteria, discovered after randomization
- •Inability to give informed consent
- •Known clotting disorder or use of anticoagulants
- •Known risk factors for, or presence of, a cardiovascular disease
- •Language barrier
Arms & Interventions
Misoprostol
Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive an oral placebo.
Intervention: Misoprostol
Misoprostol and Mifepristone
Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive oral mifepristone (600mg).
Intervention: Mifepristone
Misoprostol and Mifepristone
Before medical treatment with misoprostol (two doses 400mcg (four hours apart), repeated after 24 hours if no tissue is lost), patients receive oral mifepristone (600mg).
Intervention: Misoprostol
Outcomes
Primary Outcomes
Complete evacuation
Time Frame: six weeks after initial treatment
Whether or not complete evacuation (total endometrial thickness \<15 mm) has been acquired will be assessed through ultrasonography.
Secondary Outcomes
- Overall quality of health, as experienced by the patient.(At baseline, day four, and two and six weeks after initial treatment.)
- patient satisfaction(At baseline, day four, two and six weeks after treatment)
- costs(up to six weeks after treatment)
- side effects(six weeks after treatment)
- complications(six weeks after treatment)