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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
220
Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg
Regular treatment with vaginal Misoprostol 800 mcg
Clinical Hospital Merkur
Zagreb, City of Zagreb, Croatia
RECRUITINGNumber 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.
Time frame: Three weeks after randomization
Total misoprostol dose used
Total dose of misoprostol used during treatment
Time frame: Up to three weeks after randomization
Complications
Frequency of complications (by type)
Time frame: Up to three weeks after randomization
Side effects
Type and degree of side effects experienced as reported in the patient's diary
Time frame: Up to three weeks after randomization
Duration of vaginal bleeding
Duration of vaginal bleeding as reported in the patient's diary
Time frame: Up to three weeks after randomization
Hemoglobin change
Hemoglobin change from randomization until three weeks after treatment
Time frame: At randomization and three weeks after randomization
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
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Time frame: At randomization, 24 hours after taking first misoprostol dose and three weeks after randomization
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
Time frame: Three weeks after randomization
Indication for surgical treatment
Type and incidence of indications for surgical evacuation of uterus in case of unsuccessful medical treatment
Time frame: Three weeks after randomization