The comparison of two drug treatments for miscarriage

Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a pilot study - M&M trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001554-10-NL

Enrollment

Unknown

Registered

2016-06-01

Start date

2016-06-21

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women aged above 18 years with early pregnancy failure, 6-14 weeks postmenstrual. MedDRA version: 19.0 Level: LLT Classification code 10068522 Term: Non-surgical treatment System Organ Class: 100000004865 MedDRA version: 19.0 Level: LLT Classification code 10027650 Term: Miscarriage of pregnancy System Organ Class: 100000004868

Interventions

Trade Name: Mifegyne Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Early pregnancy failure, 6-14 weeks postmenstrual with a o Crown-rump length = 6mm and no cardiac activity OR o Gestational sac without embryonic pole, confirmed by a second ultrasound at least one week later • 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 18 years • Hemodynamic stable patient • No signs of infection • No signs of incomplete abortion • No contraindications for mifepristone or misoprostol • No high risk of thrombosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient does not meet inclusion criteria, discovered after randomization

Design outcomes

Primary

Measure	Time frame
Main Objective: Th??is study will compare sequential mifepristone and misoprostol (“M&M”) treatment versus misoprostol treatment alone, which is currently the standard medical treatment in the Netherlands.;Secondary Objective: The secondary objectives are patient satisfaction, side effects and complications.;Primary end point(s): The primary outcome will be complete evacuation of the products of conception from the uterus, which is determined by routinely ultrasonography six to nine days after treatment.;Timepoint(s) of evaluation of this end point: One week after treatment.	—

Measure

Time frame

Main Objective: Th??is study will compare sequential mifepristone and misoprostol (“M&M”) treatment versus misoprostol treatment alone, which is currently the standard medical treatment in the Netherlands.;Secondary Objective: The secondary objectives are patient satisfaction, side effects and complications.;Primary end point(s): The primary outcome will be complete evacuation of the products of conception from the uterus, which is determined by routinely ultrasonography six to nine days after treatment.;Timepoint(s) of evaluation of this end point: One week after treatment.

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary objectives are patient satisfaction, side effects and complications.;Timepoint(s) of evaluation of this end point: Six weeks after treatment.	—

Countries

Netherlands

Contacts

Public ContactAfdeling Gynaecologie

Radboudumc

menm.trial@gmail.com+310243614788

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026