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

NCT05124314 | Unknown Phase 4

• 1 other identifier: 2021-0001
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion, Missed

Keywords

Missed miscarriage; Mifepristone; Misoprostol; Medical management

Outcome Measures

Primary Outcomes (1)

• Number of participants with complete evacuation of uterus

  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 Outcomes (8)

• Total misoprostol dose used

  Up to three weeks after randomization

• Complications

  Up to three weeks after randomization

• Side effects

  Up to three weeks after randomization

• Duration of vaginal bleeding

  Up to three weeks after randomization

• Hemoglobin change

  At randomization and three weeks after randomization

Study Arms (2)

Mifepristone and Misoprostol

EXPERIMENTAL

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; Drug: Misoprostol Pill

Misoprostol

ACTIVE COMPARATOR

Medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost).

Drug: Misoprostol Pill

Interventions

Mifepristone, Oral, 200 Mg DRUG

Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg

Also known as: Mifegyne

Mifepristone and Misoprostol

Misoprostol Pill DRUG

Regular treatment with vaginal Misoprostol 800 mcg

Also known as: Mispregnol

Mifepristone and Misoprostol; Misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Merkur: lead
• University of Zagreb School of Medicine: collaborator

Study Sites (1)

Clinical Hospital Merkur

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Abortion, Missed; Abortion, Incomplete

Interventions

Mifepristone; Misoprostol

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mate Milas, MD

  Clinical Hospital Merkur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mate Milas, MD

CONTACT

+385992060290; milas.mate@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 17, 2021
• Study Start: October 27, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)