Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Not Applicable

Completed

• Conditions: Incomplete Abortion
• Interventions: Drug: Misoprostol

• Registration Number: NCT02707653
• Lead Sponsor: Gynuity Health Projects

Brief Summary

This study will investigate the use of misoprostol for first-line treatment of incomplete abortion at tertiary hospitals in Myanmar.

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 Timeline

• Study First Submitted: 2016-02-19
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-08
• Last Update Posted: 2018-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Miso	Misoprostol	Misoprostol 400 s/l

Primary Outcome Measures

Name	Time	Method
Percentage of women with complete uterine evacuation with study medication alone.	14 days

Secondary Outcome Measures

Name	Time	Method
Level of self-reported acceptability of treatment	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.
Percentage of women experiencing side effects	7-14 days	occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.

Trial Locations

Locations (2)

Thingyan Sanpya Hospital; 🇲🇲 Yangon, Myanmar

Central Woman's Hospital; 🇲🇲 Yangon, Myanmar