NCT05124314

Comparison of Two Different Drug Regimens for Medical Treatment of Early Pregnancy Loss

Comparison of Efficacy and Safety of Sequential Use of Mifepristone and Misoprostol vs Misoprostol Alone in Women With Early Pregnancy Loss: Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Clinical Hospital Merkur · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abortion, Missed

Interventions

Type	Name	Description
DRUG	Mifepristone, Oral, 200 Mg	Adding 600 mg of oral Mifepristone to the regular treatment with vaginal Misoprostol 800 mcg
DRUG	Misoprostol Pill	Regular treatment with vaginal Misoprostol 800 mcg

Timeline

• Start date: 2021-10-27
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2021-11-17
• Last updated: 2021-11-17

Locations

1 site across 1 country: Croatia