NL-OMON48955
Completed
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- early pregnancy failure
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 352
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility 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 \<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
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
Outcomes
Primary Outcomes
Not specified
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