Comparing Two Medical Treatments for Early Pregnancy Failure.

• Status: Terminated
• Trial end date: 2020-03-16
• Target enrollment: 0
• Participant gender: Female

Summary

This study aims to compare whether a combination of two drugs (Mifepristone and misoprostol) are superior compared to using only one of these drugs (Misoprostol) as medical treatment for a miscarriage. Women in whom early pregnancy failure, 6-14 weeks postmenstrual, is ultrasonographically confirmed qualify for this study.

It is expected that the combination of Mifepristone and Misoprostol is more effective in reaching complete evacuation, and therefore can prevent more invasive treatment such as curettage.

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

Details

• Lead Sponsor: Radboud University
• Collaborators: Canisius-Wilhelmina Hospital; Innovatiefonds Zorgverzekeraars
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

Early pregnancy failure, 6-14 weeks postmenstrual with

• a crown-rump length ≥ 6mm and no cardiac activity OR

• a crown-rump length <6mm and no fetal growth at least one week later OR

• a gestational sac with absent embryonic pole for at least one week.

• At least one week after diagnosis OR a discrepancy of at least one week between crown-rump length and calendar gestational age

• Intra-uterine pregnancy

• Women aged above 16 years

• Hemodynamic stable patient

• No signs of infection

• No signs of incomplete abortion

• No contraindications for mifepristone or misoprostol

Exclusion Criteria:

• Patient does not meet inclusion criteria, discovered after randomization

• Inability to give informed consent

• Known clotting disorder or use of anticoagulants

• Known risk factors for, or presence of, a cardiovascular disease

• Language barrier