Clinical trial NCT05124314: Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Abortion, Missed
Keywords: Missed miscarriage
Mifepristone
Misoprostol
Medical management
Lead sponsor: Clinical Hospital Merkur
Sponsor class: OTHER
Collaborators: name: University of Zagreb School of Medicine
First posted: 2021-11-17
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with complete evacuation of uterus
timeFrame: Three weeks after randomization
Secondary outcomes:
measure: Total misoprostol dose used
timeFrame: Up to three weeks after randomization
measure: Complications
timeFrame: Up to three weeks after randomization
measure: Side effects
timeFrame: Up to three weeks after randomization
measure: Duration of vaginal bleeding
timeFrame: Up to three weeks after randomization
measure: Hemoglobin change
timeFrame: At randomization and three weeks after randomization
measure: Patient quality of life
timeFrame: At randomization, 24 hours after taking first misoprostol dose and three weeks after randomization
measure: Patient satisfaction
timeFrame: Three weeks after randomization
measure: Indication for surgical treatment
timeFrame: Three weeks after randomization
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Merkur
state: Grad Zagreb
Study officials:
affiliation: Clinical Hospital Merkur
name: Mate Milas, MD
role: PRINCIPAL_INVESTIGATOR
References: