NCT03212352

Comparing Two Medical Treatments for Early Pregnancy Failure.

Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Conditions

• Early Pregnancy Failure

Interventions

Type	Name	Description
DRUG	Mifepristone	Adding 600 mg of Mifepristone to the regular treatment with Misoprostol 800 mcg.
DRUG	Misoprostol	Regular treatment with Misoprostol 800 mcg.

Timeline

• Start date: 2018-06-27
• Primary completion: 2020-01-23
• Completion: 2020-03-16
• First posted: 2017-07-11
• Last updated: 2020-05-01

Locations

13 sites across 1 country: Netherlands