Status:
COMPLETED
Misoprostol for the Treatment of Incomplete Abortion
Lead Sponsor:
Gynuity Health Projects
Collaborating Sponsors:
Befelatanana Maternity Centre
Municipal Clinical Hospital No. 1
Conditions:
Abortion, Incomplete
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion. Women diagnosed with incomplete abortion will be randomized to receive o...
Eligibility Criteria
Inclusion
- If no ultrasound used:
- Past or present history of vaginal bleeding during pregnancy; and
- Open cervical os.
- If ultrasound used:
- Past or present history of vaginal bleeding during pregnancy; and
- 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.
- Willing to provide contact information for purposes of follow-up.
- In Tanzania: 18 years of age or over or parental permission
- In Mozambique: 21 years of age or over or parental permission
- In Moldova: 18 years of age or over
- In Madagascar: 18 years of age or parental permission
- In Vietnam: reproductive age
Exclusion
- Contraindications to the study drug;
- Uterine size larger than 12 weeks L.M.P. at time of presentation for care.
- Signs of severe infection, defined as at least one of the following of:
- foul smelling discharge,
- fever \> 39 degrees C ,
- pulse \>110/min;
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT00670761
Start Date
July 1 2004
End Date
December 1 2010
Last Update
July 27 2016
Active Locations (6)
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1
Hôpital de District Sanitaire Dandé
Bobo-Dioulasso, Burkina Faso
2
Hôpital de District Sanitaire de Ziniaré
Ouagadougou, Burkina Faso
3
Befelatanana Maternity Centre
Antananarivo, Madagascar
4
Municipal Clinical Hospital
Chishinau, Moldova