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

Overview

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.

Full Title of Study: “A Randomized Controlled Trial to Compare Sublingual and Buccal Misoprostol Regimens After Mifepristone for Termination of Pregnancy 13 – 21 Weeks From Last Menstrual Period (LMP)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2016

Detailed Description

Eligible women 13-21 weeks gestation who give informed consent will be randomized to receive buccal or sublingual misoprostol. Participants will take 200mg mifepristone and return to the hospital 24 hours later to begin induction with misoprostol. 400mcg misoprostol will be given every 3 hours until the expulsion of the fetus and placenta.

Interventions

  • Drug: Mifepristone
    • 200mg oral mifepristone to both study arms
  • Drug: Buccal misoprostol
    • doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone
  • Drug: Sublingual misoprostol
    • doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone

Arms, Groups and Cohorts

  • Active Comparator: Sublingual misoprostol
    • 200mg mifepristone + 400mcg sublingual misoprostol q3h
  • Active Comparator: Buccal misoprostol
    • 200mg mifepristone + 400mcg buccal misoprostol q3h

Clinical Trial Outcome Measures

Primary Measures

  • Rate of successful abortion by 24 hours
    • Time Frame: 24 hours following the start of misoprostol
    • Defined as complete evacuation of uterus at 24 hours following start of misoprostol, using study drugs without recourse to any additional intervention.
  • Rate of successful abortion by 48 hours
    • Time Frame: 48hours following the start of misoprostol
    • Defined as complete evacuation of uterus at 48 hours following start of misoprostol, using study drugs without recourse to any additional intervention.

Secondary Measures

  • Median time from first dose of misoprostol to complete expulsion of complete expulsion (provider diagnosis of complete expulsion of fetus and placenta).
    • Time Frame: 48 hours
  • Percentage of patients requiring provision of additional interventions.
    • Time Frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
  • Total number of doses of misoprostol.
    • Time Frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
  • Rates of heavy bleeding, uterine rupture, or infection requiring additional treatment
    • Time Frame: 1 month
  • Pain scale (1-7) as reported by women on questionnaire
    • Time Frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours
  • Women’s acceptability of the assigned method based on 5 point acceptability scale in questionnaire
    • Time Frame: from first drug dose to complete expulsion as documented on study forms, up to 72 hours

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Gynuity Health Projects
  • Collaborator
    • La Rabta Maternity Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Beverly Winikoff, MD, MPH, Principal Investigator, Gynuity Health Projects

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