Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening.
NCT ID: NCT01170819
Last Updated: 2011-12-13
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
PHASE4
210 participants
INTERVENTIONAL
2010-06-30
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dinoprostone Vaginal Insert
Dinoprostone 10 mg controlled-release vaginal insert
Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.
Double Balloon Catheter
Double balloon catheter
The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred.
Interventions
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Double balloon catheter
The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred.
Dinoprostone 10 mg controlled-release vaginal insert
Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* gestational age greater than 34 weeks
* cephalic presentation
* intact membranes
* Bishop score of ≤4
* reactive fetal heart rate (FHR) pattern on admission
Exclusion Criteria
* any contraindication to receiving prostaglandins, including history of asthma, glaucoma, or cardiac or cardiovascular disease
* previous cesarean section or other uterine incision
18 Years
FEMALE
No
Sponsors
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Università degli Studi dell'Insubria
OTHER
Responsible Party
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Antonella Cromi
PhD
Locations
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Del Ponte Hospital
Varese, , Italy
Countries
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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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1229
Identifier Type: -
Identifier Source: org_study_id