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

July 13, 2016 updated by: Gynuity Health Projects

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

320

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

  • Armenia
      • Yerevan, Armenia
        • Recruiting
        • b. Republican Institute of Reproductive Health, Perinatology, Obstetrics and Gynecology (RIRHPOG)
        • Contact:
        • Principal Investigator:
          • Ruzanna Abrahamyan, MD
  • Nepal
      • Kathmandu, Nepal
        • Recruiting
        • Kathmandu Medical College
        • Contact:
        • Principal Investigator:
          • Chanda Karki, MD
  • Tunisia
      • Tunis, Tunisia
        • Recruiting
        • La Rabta Maternity Hospital
        • Contact:
        • Principal Investigator:
          • Ezzedine Sfar, MD
  • Uzbekistan
      • Tashkent, Uzbekistan
        • Recruiting
        • Clinic No. 2, Tashkent Medical Academy
        • Contact:

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:

  • 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)

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: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Sublingual misoprostol
200mg mifepristone + 400mcg sublingual misoprostol q3h
Drug: Mifepristone
200mg oral mifepristone to both study arms
Other Names:
  • Mifeprex
  • Mifegyne
  • miropristone
Drug: Sublingual misoprostol
doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone
Other Names:
  • cytotec
ACTIVE_COMPARATOR: Buccal misoprostol
200mg mifepristone + 400mcg buccal misoprostol q3h
Drug: Mifepristone
200mg oral mifepristone to both study arms
Other Names:
  • Mifeprex
  • Mifegyne
  • miropristone
Drug: Buccal misoprostol
doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone
Other Names:
  • cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours following the start of misoprostol
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.
48hours following the start of misoprostol

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
from first drug dose to complete expulsion as documented on study forms, up to 72 hours

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Collaborators

Kathmandu Medical College and Teaching Hospital
La Rabta Maternity Hospital
Republican Institute of RH, Perinatology, and Ob/Gyn
Clinic No. 2 of Tashkent Medical Academy

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

May 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

February 10, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (ESTIMATE)

March 15, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1013

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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