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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.
This is a pragmatic cluster randomized clinical trial. The target population is nulliparous women who present for induction of labor at term. If there is a decision by the obstetric team to place a transcervical Foley dilator for cervical ripening in a prospective subject meeting inclusion criteria for the study, the obstetric provider will follow the weekly randomization sequence for study group (No Tension) or the control group (Tension) based on the assigned cluster for the entire unit for that week. Both study groups will receive standardized labor management as Foley balloon placed with tension and without tension are both considered standard of care at our institution.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of Foley balloon for cervical ripening with tension. | Other | A Foley balloon will be placed for cervical ripening with tension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Requested Analgesia Following Placement of the Foley Balloon | Request for IV pain medications or epidural following placement of 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postpartum Hemorrhage | Number of participants with postpartum hemorrhage | Placement of Foley balloon until 24 hours postpartum |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meagan V Benson, DO | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33030881 | Background | 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. | |
| 28651258 | 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. |
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Study records will be kept confidential as required by law. No IPD will be shared outside of UTMB. Identifiers will not be disclosed outside of the University of Texas Medical Branch (UTMB). The data collected will be kept on a password-secured UTMB computer. An encrypted USB flash drive will be used to transfer data. During analysis of the data, all identifiers will be deleted.
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The intervention is assigned at the cluster (weekly) level; the total number of participants enrolled will be reported as a single total and not separated by clusters.
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| ID | Title | Description |
|---|---|---|
| FG000 | Without Tension (Tension Free) | A Foley balloon is introduced into the cervix either manually or under direct visualization, but the foley will not be taped or under tension. Placement of Foley balloon for cervical ripening without tension. A Foley balloon will be placed for cervical ripening without tension. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Vaginal Delivery | Time to vaginal delivery measured from time of initial Foley balloon placement to delivery | Posted | Median | Full Range | minutes | Foley bulb placement to vaginal delivery, up to 24 Hours |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Meagan Benson, DO | University of Texas Medical Branch | 409-772-0982 | meaganbenson88@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2023 | Jun 23, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020070 | Cervical Ripening |
| ID | Term |
|---|---|
| D007743 | Labor, Obstetric |
| D011247 | Pregnancy |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
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| Placement of Foley balloon for cervical ripening without tension. | Other | A Foley balloon will be placed for cervical ripening without tension. |
|
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 | Number of participants with chorioamnionitis | Placement of Foley balloon until delivery, up to 24 Hours |
| 27018464 | 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. |
| 27640940 | 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. |
| 27922285 | 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. |
| 30089070 | 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. |
| 33278290 | 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. |
| 27824758 | 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. |
| 26244535 | 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. |
| 6018096 | 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. |
| 22419277 | 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. |
| 28486381 | 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. |
| 18515515 | 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. |
| 38422505 | Derived | 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. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants That Requested Analgesia Following Placement of the Foley Balloon | Request for IV pain medications or epidural following placement of Foley balloon | Posted | Count of Participants | Participants | Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours) |
|
|
|
| Secondary | Number of Participants That Had a Primary Cesarean Delivery | Number of participants that had a primary cesarean delivery | Posted | Count of Participants | Participants | Placement of Foley balloon until cesarean delivery, up to 24 Hours |
|
|
|
| Secondary | Number of Participants With Chorioamnionitis | Number of participants with chorioamnionitis | Posted | Count of Participants | Participants | Placement of Foley balloon until delivery, up to 24 Hours |
|
|
|
| Other Pre-specified | Number of Participants With Postpartum Hemorrhage | Number of participants with postpartum hemorrhage | Outcome measure not assessed | Posted | Placement of Foley balloon until 24 hours postpartum |
|
|
| 0 |
| 141 |
| 0 |
| 141 |
| 0 |
| 141 |
| EG001 | 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. | 0 | 138 | 0 | 138 | 0 | 138 |
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| D012101 |
| Reproductive and Urinary Physiological Phenomena |