Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks)

May 12, 2014 updated by: Gynuity Health Projects

Medical Abortion With Mifepristone + Misoprostol (13 - 22 Weeks): A Double-blind Randomized-controlled Trial

A double-blind randomized controlled trial to compare a shorter interval between the administration of mifepristone and misoprostol (simultaneous administration compared to 24hours from administration of mifepristone to receipt of the first dose of misoprostol) for termination of pregnancy up to 13-22 weeks of gestation. The investigators hypothesize that a shortened interval may achieve comparable efficacy in terminating pregnancy, whilst reducing the duration of the procedure and in turn, the duration of hospitalization.

Study Overview

Study Type

Interventional

Enrollment (Actual)

504

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hanoi, Vietnam
        • National Ob-Gyn Hospital
      • Ho Chi Minh City, Vietnam
        • Hung Vuong Hospital
    • Binh Duong Province
      • Ho Chi Minh City, Binh Duong Province, Vietnam
        • Binh duong Obstetrics and Newborn Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Closed cervical os and no vaginal bleeding
  • Live fetus at time of presentation for service
  • No contraindications to medical abortion and study procedures, according to provider
  • Able to consent to participate in the study, either by reading consent document or by having consent document read to her and sign informed consent
  • Willing to follow study procedures

Exclusion Criteria:

  • Known previous transmural uterine incision
  • > 5 parity
  • Signs and symptoms of infection
  • Any contraindications to vaginal delivery, including placenta previa
  • Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mifepristone at home 24 hours before miso dosing starts

All women will receive study packet one containing mifepristone to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing a placebo. Simultaneously, they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.

Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled.

200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
EXPERIMENTAL: Mifepristone and first dose of misoprostol simultaneously.

Will receive study packet one containing placebo to swallow at home on study day 1. They will be told to return to the hospital for induction and will be scheduled to return to the hospital 24 hours later. Upon their return, they will be hospitalized and receive another study packet containing mifepristone. Simultaneously they will receive one dose of 400 mcg buccal misoprostol. Women will remain hospitalized and receive repeated doses of 400 mcg buccal misoprostol every three hours.

Participants will receive up to eight doses of misoprostol (e.g. 3200 mcg misoprostol) over 24 hours. Misoprostol dosing will stop when both the fetus and placenta are expelled. The procedure will be considered complete once both the fetus and placenta are expelled.

200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of women who have had a complete uterine evacuation within 24 hours using study drug without recourse to any additional intervention.
Time Frame: Within 1 week
Defined as complete evacuation of fetus and placenta using study drug without recourse to any additional intervention.
Within 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction to abortion interval
Time Frame: Within 1 week
Defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus and placenta.
Within 1 week
Women's acceptability of the assigned method.
Time Frame: Within 1 week
Within 1 week
Rate of fetal expulsion
Time Frame: Within 1 week
Defined as fetal expulsion with study drug alone.
Within 1 week
Provision of additional interventions
Time Frame: Within 1 week
For example: Uterine massage, Manual removal, Sponge forceps, D&C or D&E, Repeat medical abortion drugs
Within 1 week
Time interval from the mifepristone dose to abortion
Time Frame: Within 1 week
Defined as length of time from initiation of mifepristone to complete abortion achieved.
Within 1 week
Total dose of misoprostol administered
Time Frame: Within 1 week
Within 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nguyen thi Ngoc, MD, Hung Vuong Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 11, 2013

First Posted (ESTIMATE)

January 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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