Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss
- Conditions
- Abortion, Missed
- Interventions
- Drug: Mifepristone, Oral, 200 Mg
- Registration Number
- NCT05124314
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 220
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mifepristone and Misoprostol Misoprostol Pill 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). Misoprostol Misoprostol Pill Medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost). Mifepristone and Misoprostol Mifepristone, Oral, 200 Mg 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).
- Primary Outcome Measures
Name Time Method Number of participants with complete evacuation of uterus 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
Name Time Method Complications Up to three weeks after randomization Frequency of complications (by type)
Duration of vaginal bleeding Up to three weeks after randomization Duration of vaginal bleeding as reported in the patient's diary
Total misoprostol dose used Up to three weeks after randomization Total dose of misoprostol used during treatment
Patient quality of life 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
Side effects Up to three weeks after randomization Type and degree of side effects experienced as reported in the patient's diary
Hemoglobin change At randomization and three weeks after randomization Hemoglobin change from randomization until three weeks after treatment
Indication for surgical treatment Three weeks after randomization Type and incidence of indications for surgical evacuation of uterus in case of unsuccessful medical treatment
Patient satisfaction 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
Trial Locations
- Locations (1)
Clinical Hospital Merkur
ðŸ‡ðŸ‡·Zagreb, Grad Zagreb, Croatia