Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
NCT ID: NCT03138252
Last Updated: 2022-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
2014-11-30
2017-07-31
Brief Summary
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Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cervical Ripening Balloon Alone
Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
Cervical Ripening Balloon + Oxytocin
Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.
Oxytocin
Interventions
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Oxytocin
Eligibility Criteria
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Inclusion Criteria
* Gestational age \> 34 + 0/7 weeks
* Prior spontaneous vaginal delivery
* Clinical or U/S EFW of \<4500 grams
* Singleton gestation
* Cervical dilation \<2 cm
Exclusion Criteria
* Placenta within 2 cm of cervical os
* Placental abruption, chorioamninoitis, or systemic infection prior to induction
* Rupture of membranes prior to induction -\>1 prior C/S
18 Years
FEMALE
Yes
Sponsors
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University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Locations
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Alison Bauer
Cleveland, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CRB + Oxytocin
Identifier Type: -
Identifier Source: org_study_id
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