Tension Versus Tension- Free Foley Balloon for Cervical Ripening

NCT05404776 | Completed Results

• 1 other identifier: 21-0327
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

Foley balloons are commonly used as a mechanical method of cervical ripening for induction of labor. Foley balloons may be placed either under tension or without tension (tension-free). The purpose of our study is to examine time to delivery in nulliparous women undergoing induction of labor who have a Foley balloon placed as a mechanical cervical dilator, assigned to either tension or without tension. The goal is to determine if there is a potential added benefit to placing the Foley balloon on tension as compared to no tension. Our hypothesis is that Foley balloon under tension for cervical ripening results in shorter time to vaginal delivery compared to Foley balloon placed without tension.

Conditions

Induced Vaginal Delivery

Keywords

Induced Vaginal Delivery; Cervical Ripening; Mechanical Cervical Ripening

Outcome Measures

Primary Outcomes (1)

• Time to Vaginal Delivery

  Time to vaginal delivery measured from time of initial Foley balloon placement to delivery

  Foley bulb placement to vaginal delivery, up to 24 Hours

Secondary Outcomes (3)

• Number of Participants That Requested Analgesia Following Placement of the Foley Balloon

  Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours)

• Number of Participants That Had a Primary Cesarean Delivery

  Placement of Foley balloon until cesarean delivery, up to 24 Hours

• Number of Participants With Chorioamnionitis

  Placement of Foley balloon until delivery, up to 24 Hours

Other Outcomes (1)

• Number of Participants With Postpartum Hemorrhage

  Placement of Foley balloon until 24 hours postpartum

Study Arms (2)

Without tension (tension free)

EXPERIMENTAL

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.

Other: Placement of Foley balloon for cervical ripening without tension.

Tension

ACTIVE COMPARATOR

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.

Other: Placement of Foley balloon for cervical ripening with tension.

Interventions

Placement of Foley balloon for cervical ripening with tension. OTHER

A Foley balloon will be placed for cervical ripening with tension.

Tension

Placement of Foley balloon for cervical ripening without tension. OTHER

A Foley balloon will be placed for cervical ripening without tension.

Without tension (tension free)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Term induction of labor
• 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

You may not qualify if:

• Patient unwilling or unable to provide verbal consent
• 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

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (14)

• 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.

  PMID: 33030881 BACKGROUND

• 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.

  PMID: 28651258 BACKGROUND

• 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.

  PMID: 27018464 BACKGROUND

• 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.

  PMID: 27640940 BACKGROUND

• 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.

  PMID: 27922285 BACKGROUND

• 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.

  PMID: 30089070 BACKGROUND

• 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.

  PMID: 33278290 BACKGROUND

• 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.

  PMID: 27824758 BACKGROUND

• 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.

  PMID: 26244535 BACKGROUND

• 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.

  PMID: 6018096 BACKGROUND

• 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.

  PMID: 22419277 BACKGROUND

• 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.

  PMID: 28486381 BACKGROUND

• 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.

  PMID: 18515515 BACKGROUND

• 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.

  PMID: 38422505 DERIVED

MeSH Terms

Interventions

Cervical Ripening

Intervention Hierarchy (Ancestors)

Labor, Obstetric; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Meagan Benson, DO
• Organization: University of Texas Medical Branch

meaganbenson88@gmail.com

409-772-0982

Study Officials

• Meagan V Benson, DO

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 3, 2022
• Study Start: June 3, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: August 6, 2025
• Results First Posted: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)