Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation
NCT ID: NCT00695331
Last Updated: 2008-07-10
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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UNKNOWN
PHASE4
143 participants
INTERVENTIONAL
2008-02-29
2009-01-31
Brief Summary
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Detailed Description
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In our previous trial, it has been proven that the method of titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix. Because administering Misoprostol solution is easy and cost saving, it is worth to develop this novel method in labor augmentation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Titrated Oral Misoprostol Solution
Misoprostol
Titrated Misoprostol Solution
2
Intravenous Oxytocin
Oxytocin
Titrated Intravenous Oxytocin
Interventions
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Misoprostol
Titrated Misoprostol Solution
Oxytocin
Titrated Intravenous Oxytocin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Live singleton
* Cephalic presentation
* A reassuring fetal heart rate pattern
* Bishop score greater than 6
* Inadequate uterine contraction (less than or equal to 2 per 10 minutes)
Exclusion Criteria
* Parity more than five
* Uterine scar
* Suspected placental abruption with abnormal fetal heart rate
* Vaginal bleeding other than "bloody show"
* Significant maternal cardiac, renal, or hepatic disease
* hypersensitivity to oxytocin, misoprostol or prostaglandin analogues
18 Years
45 Years
FEMALE
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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China Medical University Beigang Hospital
Principal Investigators
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Shi-Yann Cheng, MD
Role: STUDY_CHAIR
China Medical University Beigang Hospital
Locations
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Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ming Ho, MD
Role: primary
Shi-Yann Cheng, MD
Role: backup
References
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Cheng SY, Ming H, Lee JC. Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial. Obstet Gynecol. 2008 Jan;111(1):119-25. doi: 10.1097/01.AOG.0000297313.68644.71.
Ho M, Cheng SY, Li TC. Titrated oral misoprostol solution compared with intravenous oxytocin for labor augmentation: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):612-618. doi: 10.1097/AOG.0b013e3181ed36cc.
Related Links
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China Medical University Hospital
Other Identifiers
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DMR96-IRB-176
Identifier Type: -
Identifier Source: secondary_id
CMUBH R96007
Identifier Type: -
Identifier Source: org_study_id