Status:
UNKNOWN
The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor
Lead Sponsor:
University of Arizona
Conditions:
Labor Induction
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
Brief Summary
The current study is a randomized, controlled, double-blinded trial of Obstetric Cook Catheter combined with oral misoprostol for induction of labor in pregnant patients. The primary outcome to be stu...
Eligibility Criteria
Inclusion
- Single, live fetus
- Cephalic (head-first) presentation
- Reassuring fetal health assessment
- Gestational age between 23 and 42 weeks
- Maternal age 18 and above
- Bishop score less than 8 in primigravidae
- Bishop score less than 6 in multigravidae
Exclusion
- 1\. Fetal demise 2. Fetal malpresentation 3. Estimated fetal weight less than 500 grams or more than 4000 grams 4. Placenta previa 5. Non-reassuring fetal health assessment 6. Active maternal asthma exacerbation requiring additional medications from the usual medication requirements.
- 7\. History of cesarean section 8. Rupture of amniotic membrane 9. Latex allergy 10. Spontaneous labor 11. Other contraindication to vaginal delivery 12. Allergy to misoprostol of cook catheter
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01866488
Start Date
April 1 2013
End Date
October 1 2016
Last Update
August 30 2016
Active Locations (1)
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1
University of Arizona
Tucson, Arizona, United States, 85718