Non-surgical Alternatives to Treatment of Failed Medical Abortion

Overview

The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.

Full Title of Study: “Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 16, 2019

Detailed Description

This is a multi-site double-blind, randomized controlled trial to assess treatment with a repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up after medical abortion. The sample will be stratified in two cohorts: women with ongoing pregnancies <= 56 days of gestation and women with ongoing pregnancies 57-77 days of gestation. Eligible women who agree to participate in the study will be randomly assigned to either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2 for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol 24-48 hours later and another 800 mcg dose repeated in 3-12 hours. The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.

Interventions

  • Drug: Mifepristone
    • 200mg oral mifepristone
  • Drug: Misoprostol
    • 800mcg buccal misoprostol
  • Drug: Placebo mifepristone
    • Matching placebo pill of 200mg mifepristone
  • Drug: Placebo misoprostol
    • Matching placebo pills of 800mcg misoprostol

Arms, Groups and Cohorts

  • Experimental: Mifepristone-misoprostol
    • Women randomized to receive 200 mg mifepristone to take on Day 1, 800 mcg buccal misoprostol to take 24-48 hours after later, and four placebo misoprostol pills to take a further 3-12 hours later.
  • Experimental: Misoprostol-misoprostol
    • Women randomized to receive a placebo mifepristone pill to take on Day 1 and two doses of 800 mcg buccal misoprostol, the first of which should be taken 24-48 hours after the placebo and the second of which should be taken 3-12 hours after the first misoprostol dose.

Clinical Trial Outcome Measures

Primary Measures

  • The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason.
    • Time Frame: One week after taking first study medication

Secondary Measures

  • The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention
    • Time Frame: One week after taking first study medication
  • The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire
    • Time Frame: One week after taking first study medication

Participating in This Clinical Trial

Inclusion Criteria

  • Have ultrasound evidence of an ongoing pregnancy (embryo with cardiac activity) <= 77 days gestational age at follow-up after using a mifepristone-misoprostol regimen for termination of pregnancy – Agree to comply with study procedures – Able to consent to study participation Exclusion Criteria:

  • Have an ongoing pregnancy but did not take an initial course of mifepristone and misoprostol at the study site – Are < 18 years old in US and Canadian sites – Present with other medical abortion outcomes including persistent non-viable pregnancies or empty sac – Are unable to provide contact information for follow-up purposes

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Gynuity Health Projects
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ilana Dzuba, MHS, Principal Investigator, Gynuity Health Projects
    • Tara Shochet, PhD, MPH, Principal Investigator, Gynuity Health Projects

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