Incomplete Abortion
Conditions
Keywords
incomplete abortion, spontaneous miscarriage
Brief summary
This study aims to compare the efficacy, side effects profile and acceptability of a single dose of 600mcg misoprostol taken orally compared to standard surgical treatment as per local protocols for the treatment of incomplete abortion.
Interventions
DRUG600 mcg misoprostol
single dose of misoprostol taken orally
PROCEDURESurgical treatment
Either dilation and curettage or manual vacuum aspiration, as per local protocol
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* past or present history of vaginal bleeding during pregnancy * open cervical os * evidence of incomplete abortion with substantial debris in the uterus (if using ultrasound) * surgical evacuation of the uterus would be advised as course of action if misoprostol was not available * generally in good health * woman lives or works within one hour of study site * woman willing to provide contact information for follow up purposes * informed consent given
Exclusion criteria
* contraindications to study drug * uterine size larger than 12 weeks LMP * signs of severe infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason | one week after initial treatment |
Secondary
| Measure | Time frame |
|---|---|
| side effects | measured at follow up visit one week after initial treatment |
| acceptability | measured at follow up visit one week after initial treatment |
Countries
Ecuador, Venezuela
Outcome results
None listed