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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05124314
Recruitment Status : Recruiting
First Posted : November 17, 2021
Last Update Posted : November 17, 2021
Sponsor:
Collaborator:
University of Zagreb School of Medicine
Information provided by (Responsible Party):
Mate Milas, Clinical Hospital Merkur

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Abortion, Missed Drug: Mifepristone, Oral, 200 Mg Drug: Misoprostol Pill Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, parallel group, single center study. Before receiving vaginal misoprostol (800 mcg, repeated after 24 hours if no pregnancy tissue is lost), patients will be randomized to either oral mifepristone (600 mg) or nothing.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Sequential Use of Mifepristone and Misoprostol vs Misoprostol Alone in Women With Early Pregnancy Loss: Randomized Controlled Trial
Actual Study Start Date : October 27, 2021
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

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 Name: Mifegyne

Drug: Misoprostol Pill
Regular treatment with vaginal Misoprostol 800 mcg
Other Name: 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 Name: Mispregnol




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total misoprostol dose used [ Time Frame: Up to three weeks after randomization ]
    Total dose of misoprostol used during treatment

  2. Complications [ Time Frame: Up to three weeks after randomization ]
    Frequency of complications (by type)

  3. Side effects [ Time Frame: Up to three weeks after randomization ]
    Type and degree of side effects experienced as reported in the patient's diary

  4. Duration of vaginal bleeding [ Time Frame: Up to three weeks after randomization ]
    Duration of vaginal bleeding as reported in the patient's diary

  5. Hemoglobin change [ Time Frame: At randomization and three weeks after randomization ]
    Hemoglobin change from randomization until three weeks after treatment

  6. 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

  7. 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

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05124314


Contacts
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Contact: Mate Milas, MD +385992060290 milas.mate@gmail.com

Locations
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Croatia
Clinical Hospital Merkur Recruiting
Zagreb, Grad Zagreb, Croatia, 10000
Contact: Mate Milas, MD    +385992060290    milas.mate@gmail.com   
Principal Investigator: Mate Milas, MD         
Sponsors and Collaborators
Clinical Hospital Merkur
University of Zagreb School of Medicine
Investigators
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Principal Investigator: Mate Milas, MD Clinical Hospital Merkur
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Responsible Party: Mate Milas, Principal Investigator, Clinical Hospital Merkur
ClinicalTrials.gov Identifier: NCT05124314    
Other Study ID Numbers: 2021-0001
First Posted: November 17, 2021    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mate Milas, Clinical Hospital Merkur:
Missed miscarriage
Mifepristone
Misoprostol
Medical management
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Missed
Pregnancy Complications
Misoprostol
Mifepristone
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents