Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a randomized double blind placebo-controlled comparison (Triple M trial)

Mifepristone and misoprostol versus misoprostol alone for uterine evacuation after early pregnancy failure: a randomized double blind placebo-controlled comparison (Triple M trial) - Triple M trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48955

Enrollment

464

Registered

2018-01-16

Start date

2018-06-27

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

early pregnancy failure miscarriage

Interventions

After randomization at day 1 : Mifepristone 600mg in the intervention group placebo in the control group followed by the standard treatment with misoprostol : two doses of 400ug orally at day 3 a

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria

Exclusion criteria: Patient does not meet inclusion criteria, discovered after randomization. Inability to give informed consent. Contra-indication for the use of Mifepristone or Misoprostol. Interaction between study-medication and other medicine. Language barrier. Known clotting disorder or use of anticoagulants Known risk factors for, or presence of, a cardiovascular disease

Design outcomes

Primary

Measure	Time frame
The primary outcome will be complete evacuation of the products of conception from the uterus, which is determined by routinely ultrasonography fifteen to twenty days after treatment. Treatment is considered as succesfull when this ultrasonography shows a total endometrial thickness (TED) of 15mm) an expectant management is advised for another four weeks. Ultrasonography will again be performed six weeks after treatment to evaluate endometrial thickness. If this ultrasound shows a total endometrial thickness of	—

Measure

Time frame

The primary outcome will be complete evacuation of the products of conception from the uterus, which is determined by routinely ultrasonography fifteen to twenty days after treatment. Treatment is considered as succesfull when this ultrasonography shows a total endometrial thickness (TED) of 15mm) an expectant management is advised for another four weeks. Ultrasonography will again be performed six weeks after treatment to evaluate endometrial thickness. If this ultrasound shows a total endometrial thickness of

—

Secondary

Measure	Time frame
The secondary objectives are patient satisfaction, side effects, complications and costs.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)