Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• Closed cervical os and no vaginal bleeding

• Live fetus at time of presentation for service

• No contraindications to medical abortion and study procedures, according to provider

• Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent

• Willing to follow study procedures

Exclusion Criteria:

• Known previous transmural uterine incision

• > 5 parity

• Signs and symptoms of infection

• Any contraindications to vaginal delivery, including placenta previa

• Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)