Abortion, Missed
Conditions
Keywords
Missed miscarriage, Mifepristone, Misoprostol, Medical management
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.
Interventions
Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg
DRUGMisoprostol Pill
Regular treatment with vaginal Misoprostol 800 mcg
Sponsors
University of Zagreb School of Medicine
Clinical Hospital Merkur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complications | Up to three weeks after randomization | Frequency of complications (by type) |
| Side effects | Up to three weeks after randomization | Type and degree of side effects experienced as reported in the patient's diary |
| 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 |
| 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 |
| Indication for surgical treatment | Three weeks after randomization | Type and incidence of indications for surgical evacuation of uterus in case of unsuccessful medical treatment |
| Hemoglobin change | At randomization and three weeks after randomization | Hemoglobin change from randomization until three weeks after treatment |
Countries
Croatia
Contacts
Primary ContactMate Milas, MD
Outcome results
None listed