A Comparison of Sublingual and Buccal Misoprostol Regimens After Mifepristone for Mid-trimester Abortion

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary goal of this study is to directly compare repeat doses of sublingual and buccal routes of 400 mcg misoprostol following mifepristone for second trimester abortion in order to determine if sublingual route confers an advantage with respect to efficacy and median time to complete abortion.

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

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Clinic No. 2 of Tashkent Medical Academy; Kathmandu Medical College and Teaching Hospital; La Rabta Maternity Hospital; Republican Institute of RH, Perinatology, and Ob/Gyn
• Treatments: Mifepristone; Misoprostol

Criteria

Inclusion Criteria:

• Meet criteria to obtain abortion

• Present with closed cervical os and no vaginal bleeding

• Live fetus at time of presentation for service

• Have no contraindications to study procedures, according to provider

• Be able to consent to procedure, either by reading consent document or by having consent document read to her

• Be willing to follow study procedures

Exclusion Criteria:

• Known previous transmural uterine incision

• Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol

• Any contraindications to vaginal delivery

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