Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)

Gynuity Health Projects

Status and phase

Terminated

Phase 3

Conditions

Abortion, Induced

Treatments

Drug: Mifepristone+misoprostol

Drug: Placebo+Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT00957346

1.3.2

Details and patient eligibility

About

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 20 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.

Enrollment

20 estimated patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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)