Tension Versus Tension- Free Foley Balloon for Cervical Ripening
NCT ID: NCT05404776
Last Updated: 2025-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
279 participants
INTERVENTIONAL
2022-06-03
2023-06-21
Brief Summary
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Detailed Description
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The Tension standard of care (control group) will undergo induction of labor by placement of a transcervical Foley balloon, which is standard of care at our institution. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
The No Tension standard of care (study group) will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Subjects in the control and study group will then undergo standard intrapartum care. The total participation time in the study will be considered terminated following delivery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Without tension (tension free)
The study group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be left free of tension and will hang freely.
Placement of Foley balloon for cervical ripening without tension.
A Foley balloon will be placed for cervical ripening without tension.
Tension
The control group will undergo induction of labor by placement of a transcervical Foley balloon. The balloon tubing will be pulled to create tension and will then be taped to the patient's inner thigh.
Placement of Foley balloon for cervical ripening with tension.
A Foley balloon will be placed for cervical ripening with tension.
Interventions
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Placement of Foley balloon for cervical ripening with tension.
A Foley balloon will be placed for cervical ripening with tension.
Placement of Foley balloon for cervical ripening without tension.
A Foley balloon will be placed for cervical ripening without tension.
Eligibility Criteria
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Inclusion Criteria
* Nulliparous
* Vertex
* Singleton
* Plan for Foley balloon placement by the managing obstetrics team
* Cervical exam less than 3 cm dilated and less than or equal to 60% effaced
Exclusion Criteria
* Fetal demise or major congenital anomaly
* Preterm (\<37 0/7weeks)
* Multiple gestation
* Previous uterine surgery
* Abnormal placentation
* Malpresentation
* Magnesium infusion for preeclampsia with severe features
* Prelabor rupture of membranes
* Fetal growth restriction
* Non-reassuring fetal heart rate tracing prior to inclusion
18 Years
50 Years
FEMALE
Yes
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Meagan V Benson, DO
Role: PRINCIPAL_INVESTIGATOR
University of Texas
Locations
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University of Texas Medical Branch
Galveston, Texas, United States
Countries
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References
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Adhikari EH, Nelson DB, McIntire DD, Leveno KJ. Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial. Obstet Gynecol. 2020 Nov;136(5):953-961. doi: 10.1097/AOG.0000000000004123.
Connolly KA, Kohari KS, Factor SH, Rekawek P, Miller MR, Smilen BS, Stone JL, Bianco AT. A Randomized Trial of Foley Balloon Induction of Labor Trial in Multiparas (FIAT-M). Am J Perinatol. 2017 Sep;34(11):1108-1114. doi: 10.1055/s-0037-1603994. Epub 2017 Jun 26. No abstract available.
Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.
Fruhman G, Gavard JA, Amon E, Flick KV, Miller C, Gross GA. Tension compared to no tension on a Foley transcervical catheter for cervical ripening: a randomized controlled trial. Am J Obstet Gynecol. 2017 Jan;216(1):67.e1-67.e9. doi: 10.1016/j.ajog.2016.09.082. Epub 2016 Sep 15.
El Khouly NI. A prospective randomized trial comparing Foley catheter, oxytocin, and combination Foley catheter-oxytocin for labour induction with unfavourable cervix. J Obstet Gynaecol. 2017 Apr;37(3):309-314. doi: 10.1080/01443615.2016.1239075. Epub 2016 Dec 6.
Grobman WA, Rice MM, Reddy UM, Tita ATN, Silver RM, Mallett G, Hill K, Thom EA, El-Sayed YY, Perez-Delboy A, Rouse DJ, Saade GR, Boggess KA, Chauhan SP, Iams JD, Chien EK, Casey BM, Gibbs RS, Srinivas SK, Swamy GK, Simhan HN, Macones GA; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Labor Induction versus Expectant Management in Low-Risk Nulliparous Women. N Engl J Med. 2018 Aug 9;379(6):513-523. doi: 10.1056/NEJMoa1800566.
Kuhlmann MJ, Spencer N, Garcia-Jasso C, Singh P, Abdelwahab M, Vaughn M, Marshall K, Prasad N, Soulsby-Monroy R, Saade GR, Saad AF. Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):139-145. doi: 10.1097/AOG.0000000000004182.
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.
McMaster K, Sanchez-Ramos L, Kaunitz AM. Evaluation of a Transcervical Foley Catheter as a Source of Infection: A Systematic Review and Meta-analysis. Obstet Gynecol. 2015 Sep;126(3):539-551. doi: 10.1097/AOG.0000000000001002.
Embrey MP, Mollison BG. The unfavourable cervix and induction of labour using a cervical balloon. J Obstet Gynaecol Br Commonw. 1967 Feb;74(1):44-8. doi: 10.1111/j.1471-0528.1967.tb03931.x. No abstract available.
Jozwiak M, Bloemenkamp KW, Kelly AJ, Mol BW, Irion O, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2012 Mar 14;(3):CD001233. doi: 10.1002/14651858.CD001233.pub2.
Schoen CN, Grant G, Berghella V, Hoffman MK, Sciscione A. Intracervical Foley Catheter With and Without Oxytocin for Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jun;129(6):1046-1053. doi: 10.1097/AOG.0000000000002032.
Pettker CM, Pocock SB, Smok DP, Lee SM, Devine PC. Transcervical Foley catheter with and without oxytocin for cervical ripening: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1320-6. doi: 10.1097/AOG.0b013e31817615a0.
Benson M, Younes L, Watson A, Saade GR, Saad AF. Applying Tension to the Transcervical Foley Balloon and Delivery Times in Term Nulliparous Women Undergoing Induction of Labor: A Randomized Controlled Trial. Obstet Gynecol. 2024 May 1;143(5):670-676. doi: 10.1097/AOG.0000000000005546. Epub 2024 Feb 29.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21-0327
Identifier Type: -
Identifier Source: org_study_id
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