Length of Cook Catheter Placement and Induction of Labor
NCT ID: NCT04233008
Last Updated: 2022-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
178 participants
INTERVENTIONAL
2019-01-01
2020-07-01
Brief Summary
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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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6 hour foley
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 6 hours, determined by randomization. At that point health care providers will manage active labor.
Foley catheter length
see arm description
12 hour foley
The participant will have a cook catheter inserted digitally or by direct visualization with a speculum with the uterine component of the balloon inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. Participants will be started on hospital-based oxytocin protocol. The cook catheter will then be removed at 12 hours, determined by randomization. At that point health care providers will manage active labor.
No interventions assigned to this group
Interventions
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Foley catheter length
see arm description
Eligibility Criteria
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Exclusion Criteria
* Contraindications to vaginal delivery
* Prior cesarean section
18 Years
50 Years
FEMALE
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Sarah E Little
Director of Clinical Research
Principal Investigators
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Sarah E Little, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, Harvard Medical School, Boston MA
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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References
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Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.
Cromi A, Ghezzi F, Agosti M, Serati M, Uccella S, Arlant V, Bolis P. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011 Apr;204(4):338.e1-7. doi: 10.1016/j.ajog.2010.11.029. Epub 2011 Jan 26.
Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.
Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
Lassey SC, Haber HR, Kanbergs A, Robinson JN, Little SE. Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2021 Jun;224(6):611.e1-611.e8. doi: 10.1016/j.ajog.2021.03.021. Epub 2021 Mar 23.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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54321
Identifier Type: -
Identifier Source: org_study_id
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