Study of Sublingual Versus Oral Misoprostol Administration Following Mifepristone 200 mg for Abortion up to 63 Days Gestation
NCT ID: NCT00286208
Last Updated: 2014-02-19
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
1443 participants
INTERVENTIONAL
2005-08-31
2008-01-31
Brief Summary
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The goal of this study is to provide answers to the following four questions:
1. Is a regimen of medical abortion with mifepristone using sublingual misoprostol at least as effective as using oral misoprostol up to 63 days since the last menstrual period (LMP)?
2. Are the side effects with sublingual use tolerable for women?
3. Is sublingual administration of misoprostol acceptable to women?
4. Is one of the regimens (sublingual or oral) superior in terms of efficacy, safety (side-effects) or acceptability?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sublingual Misoprostol
400 mcg of sublingual misoprostol
Mifepristone, misoprostol
Oral Misoprostol
Misoprostol administered orally
Mifepristone, misoprostol
Interventions
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Mifepristone, misoprostol
Eligibility Criteria
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Inclusion Criteria
* Possibility of final gestational age of less than or equal to 63 days
* General good health
* Willing to provide contact information for purposes of follow-up
Exclusion Criteria
* Women presenting for medical abortion who do not consent to participate
FEMALE
Yes
Sponsors
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Gynuity Health Projects
OTHER
Responsible Party
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Principal Investigators
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Sheila Raghavan, M.Sc.
Role: STUDY_DIRECTOR
Gynuity Health Projects
Beverly Winikoff, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Gynuity Health Projects
Rasha Dabash, MPH
Role: STUDY_DIRECTOR
Gynuity Health Projects
Selma Hajri, MD
Role: PRINCIPAL_INVESTIGATOR
Reproductive Health Consultant
Ayse Akin, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Baskent University
Ilana Dzuba, MHS
Role: STUDY_DIRECTOR
Gynuity Health Projects
Locations
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State University of Medicine and Pharmacy
Chisinau, , Moldova
Centre de Planification Familiale de l'Ariana
Aryanah, , Tunisia
Centre de Planification Familiale la Bardo
Tunis, , Tunisia
Maternité de La Rabta
Tunis, , Tunisia
Private clinic
Tunis, , Tunisia
Dr. Zekai Tahir Burak Women's Health Training and Research Hospital
Ankara, , Turkey (Türkiye)
MoH Ankara Etlik Maternity and Gyneacological Training Hospital
Ankara, , Turkey (Türkiye)
Haydarpaşa Numune Training and Research Hospital Family Planning Clinic
Istanbul, , Turkey (Türkiye)
Ege Maternity and Gyneacological Training and Research Hospital
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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1.1.5
Identifier Type: -
Identifier Source: org_study_id
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