Incomplete Abortion
Conditions
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.
Interventions
DRUGMisoprostol
400 mcg sublingual misoprostol
Sponsors
Department of Medical Research, Lower Myanmar
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of women with complete uterine evacuation with study medication alone. | 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of women experiencing side effects | 7-14 days | occurrence of side effects, if any, including fever, chills, nausea, vomiting, headache, diarrhea, and pain. |
| 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. |
Countries
Burma
Outcome results
None listed