Who is sponsoring NCT05124314?

NCT05124314 is sponsored by Clinical Hospital Merkur.

What condition does NCT05124314 study?

NCT05124314 studies Abortion, Missed.

What drugs are being tested in NCT05124314?

Interventions: Mifepristone, Oral, 200 Mg, Misoprostol Pill.

What is the status of NCT05124314?

NCT05124314 is currently UNKNOWN.

Last reviewed 2021-11-16 · How we verify

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

NCT05124314 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Clinical Hospital Merkur
Phase	Phase 4
Status	UNKNOWN
Enrolment	220
Start date	2021-10-27
Completion	2023-10

Conditions

Abortion, Missed

Interventions

Mifepristone, Oral, 200 Mg
Misoprostol Pill

Primary outcomes

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.

Countries

Croatia