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

Phase 4

Completed

• Conditions: early pregnancy failure; miscarriage; 10000211

• Registration Number: NL-OMON48955
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-03-10
• Results First Posted: 2021-01-06
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 352

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
crown­rump length and calendar gestational age
• Intra­uterine 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.
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are patient satisfaction, side effects, complications<br /><br>and costs. </p><br>