Non-surgical Alternatives to Treatment of Failed Medical Abortion

Gynuity Health Projects

Status and phase: Terminated; Phase 4

Conditions: Abortion Failure

Treatments: Drug: Mifepristone; Drug: Placebo mifepristone; Drug: Misoprostol; Drug: Placebo misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02704481

1035

Details and patient eligibility

About

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 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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

Mifepristone-misoprostol

Experimental group

Description:

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.

Treatment:

Drug: Placebo misoprostol

Drug: Misoprostol

Drug: Mifepristone

Misoprostol-misoprostol

Experimental group

Description:

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.

Treatment:

Drug: Misoprostol

Drug: Placebo mifepristone