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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05124314
Other study ID # 2021-0001
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 27, 2021
Est. completion date October 2023

Study information

Verified date November 2021
Source Clinical Hospital Merkur
Contact Mate Milas, MD
Phone +385992060290
Email milas.mate@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date October 2023
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Croatia Clinical Hospital Merkur Zagreb Grad Zagreb

Sponsors (2)

Lead Sponsor Collaborator
Clinical Hospital Merkur University of Zagreb School of Medicine

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Total misoprostol dose used Total dose of misoprostol used during treatment Up to three weeks after randomization
Secondary Complications Frequency of complications (by type) Up to three weeks after randomization
Secondary Side effects Type and degree of side effects experienced as reported in the patient's diary Up to three weeks after randomization
Secondary Duration of vaginal bleeding Duration of vaginal bleeding as reported in the patient's diary Up to three weeks after randomization
Secondary Hemoglobin change Hemoglobin change from randomization until three weeks after treatment At randomization and three weeks after randomization
Secondary Patient quality of life 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
Secondary Patient satisfaction 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
Secondary Indication for surgical treatment Type and incidence of indications for surgical evacuation of uterus in case of unsuccessful medical treatment Three weeks after randomization
See also
  Status Clinical Trial Phase
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Active, not recruiting NCT03736681 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage Phase 1
Completed NCT03636451 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage.o Phase 3
Recruiting NCT02917785 - Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion N/A
Completed NCT04906278 - Amniotomy for Second-trimester Pregnancy Termination N/A
Completed NCT03148314 - Vaginal Misoprostol In Management Of First Trimester Missed Abortion. Phase 2
Not yet recruiting NCT03799081 - Use of Fetoscopy in Missed Abortion N/A
Completed NCT00784797 - Misopristol Versus Pitocin for Second Trimester Abortion Phase 4
Completed NCT03767179 - Research of Serum Procalcitonin, ESR, CRP And Leukocyte Levels in Fertile Missed Abortion Cases
Completed NCT02515604 - Comparison of Single and Repeated Dose of Vaginal Misoprostol for the Treatment of Early Pregnancy Failure Phase 4
Completed NCT00410345 - Cervical Rippening With Antiprogesterone in Midtrimester Abortions Phase 4