Status:
UNKNOWN
Efficacy and Safety Study of Titrated Oral Misoprostol Solution for Labor Augmentation
Lead Sponsor:
China Medical University Hospital
Conditions:
Labor
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the efficacy and safety of titrated oral misoprostol solution with intravenous oxytocin for labor augmentation in women without adequate uterine contractions.
Detailed Description
Numerous labor course necessitate augmentation when uterine contractions are inadequate. When the cervix is favorable, labor augmentation attempts are more likely to be successful. Augmentation is the...
Eligibility Criteria
Inclusion
- Pregnancy between 36 and 42 weeks of gestation
- 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
- Nonreassuring fetal heart rate pattern
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT00695331
Start Date
February 1 2008
End Date
January 1 2009
Last Update
July 10 2008
Active Locations (1)
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1
Labor Unit, Department of Obstetric and Gynecology, China Medical Univertiy Hospital
Taichung, Taiwan, 404