Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14 - 21 Weeks LMP): A Randomized-controlled Double-blinded Trial

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound)

• Meet legal 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, including placenta previa

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