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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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05124314
Study type Interventional
Source Clinical Hospital Merkur
Contact Mate Milas, MD
Phone +385992060290
Email [email protected]
Status Recruiting
Phase Phase 4
Start date October 27, 2021
Completion date October 2023

See also
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Active, not recruiting NCT03736681 - Effect of Paracervical Block Volume on Pain Control for Dilation and Curettage Phase 1
Not yet recruiting NCT04906278 - Amniotomy for Second-trimester Pregnancy Termination N/A
Recruiting NCT02917785 - Testing the Efficiency of Karman Curette in the Treatment of Misoprostol Failure in Women With Missed Abortion N/A
Not yet recruiting 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