Early Pregnancy Failure Clinical Trial
Official title:
Mifepristone and Misoprostol Versus Misoprostol Alone for Uterine Evacuation After Early Pregnancy Failure: a Randomized Double Blind Placebo-controlled Comparison (Triple M Trial)
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.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03178682 -
Ultrasound Predictors of Early Pregnancy Failure in Patients With Recurrent Pregnancy Loss
|
N/A | |
| Terminated |
NCT00468299 -
MiMi: A Randomized Trial of Mifepristone and Misoprostol for Treatment of Early Pregnancy Failure
|
N/A | |
| Completed |
NCT00782860 -
Early Pregnancy Failure: Factors Affecting Successful Medical Termination Treatment
|
N/A |