Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Gynuity Health Projects75 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Incomplete Abortion

Interventions

MisoprostolDRUG

400 mcg sublingual misoprostol

Eligibility

Sex: FEMALEMin age: 12 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Central Woman's Hospital

Yangon, Burma

Thingyan Sanpya Hospital

Yangon, Burma

Outcomes

Primary Outcomes

Percentage of women with complete uterine evacuation with study medication alone.

Time frame: 14 days

Secondary Outcomes

Percentage of women experiencing side effects

occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain.

Time frame: 7-14 days

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.

Time frame: 7-14 days

Data from ClinicalTrials.gov

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