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

Last updated: November 5, 2011
Sponsor: Gynuity Health Projects
Overall Status: Terminated

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00957346
1.3.2
  • Female
  • Accepts Healthy Volunteers

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

Eligibility Criteria

Inclusion

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 havingconsent document read to her

  • Be willing to follow study procedures

Exclusion

Exclusion Criteria:

  • Known previous transmural uterine incision

  • Known allergy to mifepristone or misoprostol/prostaglandin or other contraindicationsto 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 10minutes or less)

Study Design

Total Participants: 20
Study Start date:
February 01, 2011
Estimated Completion Date:
January 31, 2012

Connect with a study center

  • University of Puerto Rico, University District Hospital Medical Science Campus

    San Juan, 00936-5067
    Puerto Rico

    Site Not Available

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