Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss
NCT ID: NCT05124314
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
220 participants
INTERVENTIONAL
2021-10-27
2023-10-31
Brief Summary
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The investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.
Detailed Description
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Primary objective: To test the hypothesis that the sequential combination of mifepristone and misoprostol is superior to misoprostol alone for the complete evacuation of uterus in patients diagnosed with early pregnancy loss.
Secondary objectives: To test the hypothesis that the addition of mifepristone reduces the need for further doses of misoprostol, duration of bleeding, complication rate and side effect frequency. The investigators will also evaluate if the addition of mifepristone improves patient satisfaction and quality of life.
Women with a diagnosis of early pregnancy loss that opt for medical treatment and sign an informed consent will be included. The participants will be randomized to two groups. First group will receive oral mifepristone (600 mg) and the second group will not. The remaining course of treatment will be the same for both groups including giving misoprostol (800 mcg vaginally) 48 hours after receiving mifepristone for the first group or immediately for the second group. 24 hours after receiving first dose of misoprostol, one more dose of misoprostol (also 800 mcg vaginally) will be given if no pregnancy tissue is lost.
Three weeks after medical treatment, primary and secondary outcomes will be assessed. In case of unsuccessful treatment (incomplete evacuation of uterus), surgical evacuation will be performed.
220 women will be randomized in a 1:1 ratio.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mifepristone and Misoprostol
Patients receive oral mifepristone (600 mg) 48 hours before medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).
Mifepristone, Oral, 200 Mg
Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg
Misoprostol Pill
Regular treatment with vaginal Misoprostol 800 mcg
Misoprostol
Medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).
Misoprostol Pill
Regular treatment with vaginal Misoprostol 800 mcg
Interventions
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Mifepristone, Oral, 200 Mg
Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg
Misoprostol Pill
Regular treatment with vaginal Misoprostol 800 mcg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18 years and older
* Intra-uterine pregnancy
* Hemodynamically stable patient
* No signs of infection
* No signs of incomplete miscarriage
* Willing and able to give informed consent
Exclusion Criteria
* Diagnosis of incomplete miscarriage
* Life threatening bleeding
* Hemodynamically unstable patient
* 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
* Previous participation in this trial
* Unable to give informed consent
18 Years
FEMALE
No
Sponsors
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University of Zagreb School of Medicine
UNKNOWN
Clinical Hospital Merkur
OTHER
Responsible Party
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Mate Milas
Principal Investigator
Principal Investigators
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Mate Milas, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Hospital Merkur
Locations
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Clinical Hospital Merkur
Zagreb, City of Zagreb, Croatia
Countries
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Central Contacts
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Facility Contacts
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Mate Milas, MD
Role: primary
Other Identifiers
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2021-0001
Identifier Type: -
Identifier Source: org_study_id