Non-surgical Alternatives to Treatment of Failed Medical Abortion

Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial

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.

Study Overview

• Status: Terminated
• Conditions: Abortion Failure
• Intervention / Treatment: Drug: Mifepristone; Drug: Misoprostol; Drug: Placebo misoprostol; Drug: Placebo mifepristone

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Concord, California, United States, 94520
      • Planned Parenthood of Northern California
    • San Diego, California, United States, 92108
      • Planned Parenthood of the Pacific Southwest
  • Colorado
    • Denver, Colorado, United States, 80207
      • Planned Parenthood of the Rocky Mountains
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • Presidential Women's Center
  • Illinois
    • Chicago, Illinois, United States, 60603
      • Planned Parenthood of Illinois
    • Chicago, Illinois, United States, 60661
      • Family Planning Associates Medical Group, Ltd.
  • Iowa
    • Des Moines, Iowa, United States, 50305
      • Planned Parenthood of the Heartland
    • Iowa City, Iowa, United States, 52245
      • Emma Goldman Clinic
  • Maine
    • Topsham, Maine, United States, 04086
      • Planned Parenthood of Northern New England
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Planned Parenthood League of Massachusetts
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Planned Parenthood of Mid and South Michigan
    • Westland, Michigan, United States, 48185
      • Northland Family Planning Clinic Inc.
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Planned Parenthood of Central and Greater Northern New Jersey
  • New York
    • Bronx, New York, United States, 10458
      • Montefiore Family Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Mifepristone; 200mg oral mifepristone; Other Names: Mifeprex; Drug: Misoprostol; 800mcg buccal misoprostol; Other Names: Cytotec; Drug: Placebo misoprostol; Matching placebo pills of 800mcg misoprostol
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.	Drug: Misoprostol; 800mcg buccal misoprostol; Other Names: Cytotec; Drug: Placebo mifepristone; Matching placebo pill of 200mg mifepristone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	One week after taking first study medication

Secondary Outcome Measures

Outcome Measure	Time Frame
The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention	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	One week after taking first study medication

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Investigators: Principal Investigator: Ilana Dzuba, MHS, Gynuity Health Projects

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 16, 2019
• Study Completion (Actual): January 16, 2019

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: medical abortion; mifepristone; misoprostol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Misoprostol; Mifepristone
• Other Study ID Numbers: 1035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No