Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Incomplete Abortion Clinical Trial

Official title:

Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707653
• Other study ID #: 2001
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2016

Study information

• Verified date: June 2018
• Source: Gynuity Health Projects
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 12 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Incomplete
• Incomplete Abortion

Intervention

Drug:
• Misoprostol
400 mcg sublingual misoprostol

Locations

Country	Name	City	State
Myanmar	Central Woman's Hospital	Yangon
Myanmar	Thingyan Sanpya Hospital	Yangon

Sponsors (2)

Lead Sponsor	Collaborator
Gynuity Health Projects	Department of Medical Research, Lower Myanmar

Country where clinical trial is conducted

Myanmar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of women with complete uterine evacuation with study medication alone.		14 days
Secondary	Percentage of women experiencing side effects	occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.	7-14 days
Secondary	Level of self-reported acceptability of treatment	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