Treatment of Incomplete Abortion With 600 Mcg Oral Misoprostol Compared to Standard Surgical Treatment
NCT ID: NCT00674232
Last Updated: 2008-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
311 participants
INTERVENTIONAL
2006-05-31
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Misoprostol
Group 1 randomized to take single dose of 600 mcg oral misoprostol
600 mcg misoprostol
single dose of misoprostol taken orally
Surgical treatment
Group 2 randomized to receive standard surgical treatment as per local protocol (D\&C or MVA)
Surgical treatment
Either dilation and curettage or manual vacuum aspiration, as per local protocol
Interventions
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600 mcg misoprostol
single dose of misoprostol taken orally
Surgical treatment
Either dilation and curettage or manual vacuum aspiration, as per local protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* uterine size larger than 12 weeks LMP
* signs of severe infection
14 Years
FEMALE
Yes
Sponsors
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Gynuity Health Projects
OTHER
Responsible Party
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Gynuity Health Projects
Principal Investigators
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Melanie Peña, MPH, MA
Role: STUDY_DIRECTOR
Gynuity Health Projects
Jill Durocher
Role: STUDY_DIRECTOR
Gynuity Health Projects
Locations
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Hospital del Dia, CEMOPLAF
Quito, , Ecuador
Hospital Gineco-obstetrico Isidro Ayora
Quito, , Ecuador
Hospital Maternidad Concepcion Palacios
Caracas, , Venezuela
Countries
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References
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Montesinos R, Durocher J, Leon W, Arellano M, Pena M, Pinto E, Winikoff B. Oral misoprostol for the management of incomplete abortion in Ecuador. Int J Gynaecol Obstet. 2011 Nov;115(2):135-9. doi: 10.1016/j.ijgo.2011.06.015. Epub 2011 Aug 26.
Related Links
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Related Info
Other Identifiers
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2.2.0
Identifier Type: -
Identifier Source: org_study_id