Status:
COMPLETED
Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Lead Sponsor:
Gynuity Health Projects
Conditions:
Incomplete Abortion
Eligibility:
FEMALE
Phase:
NA
Brief Summary
In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provid...
Eligibility Criteria
Inclusion
- Uterine size no larger than 12 weeks LMP at time of presentation for care.
- Past or present history of vaginal bleeding during pregnancy.
- Open cervical os.
- If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
- All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
- General good health.
- Willing to provide contact information for purposes of follow-up.
- Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).
Exclusion
- Contraindications to study drug
- Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever \> 38 degrees C , 3) uterine tenderness
- Hemodynamic disturbances (pulse \>110/min and systolic bp \<100)
- Have an IUD in place; (the IUD may be removed making the woman eligible)
- Suspected ectopic pregnancy
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00466999
Start Date
February 1 2007
End Date
November 1 2009
Last Update
March 30 2012
Active Locations (6)
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1
Dandé District Hospital/Ziniaré District Hospital
Dande/Ziniare, Burkina Faso
2
El-Galaa Teaching Hospital
Cairo, Egypt
3
Shatby Maternity Hospital/Alexandria University
Shatby, Alexandria, Egypt
4
Cheikh Zayed Hospital
Nouakchott, Mauritania