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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinical Hospital Merkur
• Collaborator: University of Zagreb School of Medicine
• Treatments: Mifepristone; Misoprostol

Criteria

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