Status:
COMPLETED
Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment
Lead Sponsor:
Gynuity Health Projects
Conditions:
Incomplete Abortion
Eligibility:
FEMALE
14+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- contraindications to study drug
- uterine size larger than 12 weeks LMP
- signs of severe infection
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT00674232
Start Date
May 1 2006
End Date
October 1 2007
Last Update
May 7 2008
Active Locations (3)
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1
Hospital del Dia, CEMOPLAF
Quito, Ecuador
2
Hospital Gineco-obstetrico Isidro Ayora
Quito, Ecuador
3
Hospital Maternidad Concepcion Palacios
Caracas, Venezuela