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Clinical Trials/EUCTR2016-005097-35-GB
EUCTR2016-005097-35-GB
Active, not recruiting
Phase 1

A randomised placebo-controlled trial of mifepristone and misoprostol versus misoprostol alone in the medical management of missed miscarriage - MifeMiso

niversity of Birmingham0 sites710 target enrollmentOctober 9, 2018
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ConditionsMissed miscarriage up to 13+6 weeks gestation.Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
DrugsMifegyne 200mg Tablets

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Missed miscarriage up to 13+6 weeks gestation.
Sponsor
niversity of Birmingham
Enrollment
710
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 9, 2018
End Date
TBD
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Women diagnosed with missed miscarriage by pelvic ultrasound scan in the first 13\+6 weeks of pregnancy.
  • •2\. Age 16 years and over.
  • •3\. Willing and able to give informed consent.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 20
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 690
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 0

Exclusion Criteria

  • •1\. Women opting for alternative methods of miscarriage management (expectant or surgical)
  • •2\. Diagnosis of incomplete miscarriage.
  • •3\. Life threatening bleeding.
  • •4\. Contraindications to mifepristone or misoprostol use for example chronic adrenal failure, known hypersensitivity to either drug, haemorrhagic disorders and anticoagulant therapy, prosthetic heart valve or history of endocarditis, existing cardiovascular disease, severe asthma uncontrolled by therapy or inherited porphyria.
  • •5\. Participation in any other blinded, placebo\-controlled trials of investigational medicinal products in pregnancy.
  • •6\. Previous participation in the MifeMiso trial
  • •7\. Woman not able to attend for day 6\-7 ultrasound scan

Outcomes

Primary Outcomes

Not specified

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