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| Name | Class |
|---|---|
| University of Zagreb | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mifepristone and Misoprostol | Experimental | 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 | Active Comparator | Medical treatment with vaginal misoprostol (800 mcg repeated after 24 hours if no pregnancy tissue is lost). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone, Oral, 200 Mg | Drug | Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total misoprostol dose used | Total dose of misoprostol used during treatment | Up to three weeks after randomization |
| Complications | Frequency of complications (by type) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mate Milas, MD | Contact | +385992060290 | milas.mate@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mate Milas, MD | Clinical Hospital Merkur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital Merkur | Recruiting | Zagreb | City of Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D000030 | Abortion, Missed |
| D000027 | Abortion, Incomplete |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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.
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| Misoprostol Pill | Drug | Regular treatment with vaginal Misoprostol 800 mcg |
|
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| Up to three weeks after randomization |
| Side effects | Type and degree of side effects experienced as reported in the patient's diary | Up to three weeks after randomization |
| Duration of vaginal bleeding | Duration of vaginal bleeding as reported in the patient's diary | Up to three weeks after randomization |
| Hemoglobin change | Hemoglobin change from randomization until three weeks after treatment | 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 | 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 | Three weeks after randomization |
| Indication for surgical treatment | Type and incidence of indications for surgical evacuation of uterus in case of unsuccessful medical treatment | Three weeks after randomization |
| D011083 |
| Polycyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |