Comparing Two Medical Treatments for Early Pregnancy Failure. (Triple M)

Radboud University Medical Center

Status and phase: Terminated; Phase 4

Conditions: Early Pregnancy Failure

Treatments: Drug: Mifepristone; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03212352

62449

Details and patient eligibility

About

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.

Full 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

Enrollment: 342 patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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
  • No contraindications for mifepristone or misoprostol

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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342 participants in 2 patient groups, including a placebo group

Misoprostol

Placebo Comparator group

Description:

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.

Treatment:

Drug: Misoprostol

Misoprostol and Mifepristone

Experimental group

Description:

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).

Treatment:

Drug: Misoprostol

Drug: Mifepristone