Sublingual Misoprostol for the Treatment of Incomplete Abortion: Operations Research

Gynuity Health Projects

Status: Completed

Conditions: Incomplete Abortion

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02707653

2001

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: Female

Ages: 12 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Miso

Other group

Description:

Misoprostol 400 s/l

Treatment:

Drug: Misoprostol