Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

June 8, 2018 updated by: Gynuity Health Projects
This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This open-label feasibility study seeks to examine the potential of 400μg sublingual misoprostol for the treatment of incomplete abortion provided at tertiary hospitals.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

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

  • Myanmar
      • Yangon, Myanmar
        • Central Woman's Hospital
      • Yangon, Myanmar
        • Thingyan Sanpya 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

12 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Confirmed incomplete abortion
  2. No known contraindications to the study drug
  3. Uterine size no larger than 12 weeks at time of presentation for care

  4. No signs of severe infection, defined as at least two of the following:

    • foul smelling discharge,
    • fever > 38 degrees C, 100 degrees Fahrenheit
    • uterine tenderness.
  5. No hemodynamic disturbances (pulse >110/min and systolic bp <100)
  6. General good health
  7. Agree to comply with study procedures including return for follow up visit
  8. Live or work within one hour from a study site
  9. Willing and able to sign consent forms

Exclusion Criteria:

1. Inability to provide informed consent

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Miso
Misoprostol 400 s/l
Drug: Misoprostol
400 mcg sublingual misoprostol
Other Names:
  • cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of women with complete uterine evacuation with study medication alone.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of women experiencing side effects
Time Frame: 7-14 days
occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.
7-14 days
Level of self-reported acceptability of treatment
Time Frame: 7-14 days
Woman's satisfaction with the treatment, woman's likelihood to use the treatment in the future, woman's likelihood of recommending the treatment to a friend, providers' satisfaction with the treatment, likelihood provider would recommend the treatment in a similar situation.
7-14 days

Collaborators and Investigators

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

Sponsor

Gynuity Health Projects

Collaborators

Department of Medical Research, Lower Myanmar

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 (Actual)

March 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 8, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001 (Other Grant/Funding Number: Waste Connections INC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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