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Clinical Trials/NL-OMON48955
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

Radboud Universitair Medisch Centrum0 sites352 target enrollmentTBD

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

Registry
who.int
Start Date
TBD
End Date
March 10, 2020
Last Updated
2 years ago
Study Type
Interventional

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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