The Obstetric Cook Double Balloon Catheter in Combination With Oral Misoprostol for Induction of Labor
NCT ID: NCT01866488
Last Updated: 2016-08-30
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
PHASE2
200 participants
INTERVENTIONAL
2013-04-30
2016-10-31
Brief Summary
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The hypothesis is that there is a higher vaginal delivery rate in the patient whom receive both the Obstetric Cook Catheter and the oral misoprostol.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cook Catheter, Oral Misoprostol
Cook Catheter is placed and a 50mcg misoprostol tablet is given orally. A repeat dose is administered in 3 hours.
Misoprostol
Cook Catheter, Oral Placebo
Cook Catheter is placed and a placebo tablet is given orally. A repeat dose is administered in 3 hours.
Placebo
Interventions
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Misoprostol
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Cephalic (head-first) presentation
3. Reassuring fetal health assessment
4. Gestational age between 23 and 42 weeks
5. Maternal age 18 and above
6. Bishop score less than 8 in primigravidae
7. Bishop score less than 6 in multigravidae
Exclusion Criteria
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
18 Years
50 Years
FEMALE
No
Sponsors
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University of Arizona
OTHER
Responsible Party
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Meg Hill
Fellow, Maternal Fetal Medicine
Principal Investigators
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Meg Hill, MBBS
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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University of Arizona
Tucson, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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References
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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
Other Identifiers
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12-1027-01
Identifier Type: -
Identifier Source: org_study_id
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