Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss

November 16, 2021 updated by: Mate Milas, Clinical Hospital Merkur

Comparison of Efficacy and Safety of Sequential Use of Mifepristone and Misoprostol vs Misoprostol Alone in Women With Early Pregnancy Loss: Randomized Controlled Trial

The purpose of this study is to compare the safety and efficacy of a combination of two drugs (mifepristone and misoprostol) to only one of these drugs (misoprostol) in medical management of missed miscarriage up to 13+6 weeks of pregnancy (early pregnancy loss).

The investigators aim to enroll 220 patients within two years which would be enough to determine the difference between these two treatments with confidence.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aim: To investigate the safety and efficacy of combination of mifepristone and misoprostol versus misoprostol alone in medical management of early pregnancy loss.

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Croatia
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Recruiting
        • Clinical Hospital Merkur
        • Contact:
        • Principal Investigator:
          • Mate Milas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women diagnosed with missed miscarriage in the first 13+6 weeks of pregnancy opting for medical management
  • 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:

  • Women opting for alternative methods of miscarriage management (expectant or surgical)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: Mifepristone, Oral, 200 Mg
Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg
Other Names:
  • Mifegyne
Drug: Misoprostol Pill
Regular treatment with vaginal Misoprostol 800 mcg
Other Names:
  • Mispregnol
Active Comparator: Misoprostol
Medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).
Drug: Misoprostol Pill
Regular treatment with vaginal Misoprostol 800 mcg
Other Names:
  • Mispregnol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with complete evacuation of uterus
Time Frame: Three weeks after randomization
Complete evacuation of uterus will be assessed by clinical and ultrasound examination three weeks after treatment. There should be no vaginal bleeding and no suspicion of retained products of conception on ultrasound scan (endometrial thickness <= 15 mm) to declare the treatment successful.
Three weeks after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total misoprostol dose used
Time Frame: Up to three weeks after randomization
Total dose of misoprostol used during treatment
Up to three weeks after randomization
Complications
Time Frame: Up to three weeks after randomization
Frequency of complications (by type)
Up to three weeks after randomization
Side effects
Time Frame: Up to three weeks after randomization
Type and degree of side effects experienced as reported in the patient's diary
Up to three weeks after randomization
Duration of vaginal bleeding
Time Frame: Up to three weeks after randomization
Duration of vaginal bleeding as reported in the patient's diary
Up to three weeks after randomization
Hemoglobin change
Time Frame: At randomization and three weeks after randomization
Hemoglobin change from randomization until three weeks after treatment
At randomization and three weeks after randomization
Patient quality of life
Time Frame: At randomization, 24 hours after taking first misoprostol dose and three weeks after randomization
Overall health status measured using EuroQol-5 dimensions-5 levels questionnaire's (EQ-5D-5L) VAS (visual analog scale) score ranging from 0 to 100 where 0 represents worst health the participant can imagine and 100 represents the best health the participant can imagine
At randomization, 24 hours after taking first misoprostol dose and three weeks after randomization
Patient satisfaction
Time Frame: Three weeks after randomization
Overall patient satisfaction with the treatment measured using validated paper-based Client Satisfaction Questionnaire (CSQ-8) score ranging from 4 to 32, where higher number represents higher satisfaction
Three weeks after randomization
Indication for surgical treatment
Time Frame: Three weeks after randomization
Type and incidence of indications for surgical evacuation of uterus in case of unsuccessful medical treatment
Three weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Hospital Merkur

Collaborators

University of Zagreb School of Medicine

Investigators

  • Principal Investigator: Mate Milas, MD, Clinical Hospital Merkur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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