Induced Vaginal DeliveryNCT05404776
Tension Versus Tension- Free Foley Balloon for Cervical Ripening
A study testing Placement of Foley balloon for cervical ripening with tension. and Placement of Foley balloon for cervical ripening without tension. in people with Induced Vaginal Delivery, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Induced Vaginal Delivery
- What is being tested?
- Placement of Foley balloon for cervical ripening with tension. and Placement of Foley balloon for cervical ripening without tension.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2022to 21 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Malpresentation
- Magnesium infusion for preeclampsia with severe features
- Prelabor rupture of membranes
- Fetal growth restriction
- Non-reassuring fetal heart rate tracing prior to inclusion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Tension Versus Tension-Free Foley Balloon for Cervical Ripening in Nulliparous Women Undergoing Induction of Labor: A Cluster Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Induced Vaginal Delivery
- Being tested
- Placement of Foley balloon for cervical ripening with tension., Placement of Foley balloon for cervical ripening without tension.
- Keywords
- Induced Vaginal Delivery, Cervical Ripening, Mechanical Cervical Ripening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of Foley balloon for cervical ripening with tension.Other
A Foley balloon will be placed for cervical ripening with tension.
Placement of Foley balloon for cervical ripening without tension.Other
A Foley balloon will be placed for cervical ripening without tension.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placement of Foley balloon for cervical ripening with tension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Vaginal Delivery
Time to vaginal delivery measured from time of initial Foley balloon placement to delivery
Measured: 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
Request for IV pain medications or epidural following placement of Foley balloon
Measured: Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours)
Number of Participants That Had a Primary Cesarean Delivery
Number of participants that had a primary cesarean delivery
Measured: Placement of Foley balloon until cesarean delivery, up to 24 Hours
Number of Participants With Chorioamnionitis
Number of participants with chorioamnionitis
Measured: Placement of Foley balloon until delivery, up to 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start3 Jun 2022
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Induced Vaginal DeliveryStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meagan V Benson, DO, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404776
- Sponsor's protocol ID
- 21-0327
- Status last verified
- Jul 2025
- First submitted
- 24 May 2022
- Last updated
- 6 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 33030881Connolly 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.
PubMed 28651258Connolly 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.
PubMed 27018464Fruhman 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.
PubMed 27640940El 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.
PubMed 27922285Grobman 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.
PubMed 30089070Kuhlmann 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.
PubMed 33278290Levine 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.
PubMed 27824758McMaster 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.
PubMed 26244535Embrey 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.
PubMed 6018096Jozwiak 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.
PubMed 22419277Schoen 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.
PubMed 28486381Pettker 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.
PubMed 18515515Benson 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.
PubMed 38422505
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tension Versus Tension-Free Foley Balloon for Cervical Ripening in Nulliparous Women Undergoing Induction of Labor: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05404776
- Acronym / sponsor ID
- 21-0327
- Conditions
- Induced Vaginal Delivery
- Keywords
- Induced Vaginal Delivery, Cervical Ripening, Mechanical Cervical Ripening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Posted 6 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without tension (tension free) | Experimental | Other: Placement of Foley balloon for cervical ripening without tension.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 | Other: Placement of Foley balloon for cervical ripening with 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Term induction of labor
- Nulliparous
- Vertex
- Singleton
- Plan for Foley balloon placement by the managing obstetrics team
Key exclusion criteria (11 listed)
- Patient unwilling or unable to provide verbal consent
- Fetal demise or major congenital anomaly
- Preterm (<37 0/7weeks)
- Multiple gestation
- Previous uterine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placement of Foley balloon for cervical ripening with tension.A Foley balloon will be placed for cervical ripening with tension. | Other | Tension |
| Placement of Foley balloon for cervical ripening without tension.A Foley balloon will be placed for cervical ripening without tension. | Other | Without tension (tension free) |
Primary outcome
Time to Vaginal Delivery
Time frame: Foley bulb placement to vaginal delivery, up to 24 Hours
Time to vaginal delivery measured from time of initial Foley balloon placement to delivery
3 secondary outcomes
Number of Participants That Requested Analgesia Following Placement of the Foley Balloon
Time frame: Placement of Foley balloon until removal of Foley balloon in minutes (up to 12 hours)
Number of Participants That Had a Primary Cesarean Delivery
Time frame: Placement of Foley balloon until cesarean delivery, up to 24 Hours
Number of Participants With Chorioamnionitis
Time frame: Placement of Foley balloon until delivery, up to 24 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33030881Adhikari 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.
- Background: PubMed 28651258Connolly 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.
- Background: PubMed 27018464Connolly 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.
- Background: PubMed 27640940Fruhman 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.
- Background: PubMed 27922285El 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.
- Background: PubMed 30089070Grobman 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.
- Background: PubMed 33278290Kuhlmann 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.
- Background: PubMed 27824758Levine 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.
- Background: PubMed 26244535McMaster 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.
- Background: PubMed 6018096Embrey 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.
- Background: PubMed 22419277Jozwiak 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.
- Background: PubMed 28486381Schoen 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meagan V Benson, DO principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of Foley balloon for cervical ripening with tension. and Placement of Foley balloon for cervical ripening without tension. in people with Induced Vaginal Delivery, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Vaginal Delivery (time frame: Foley bulb placement to vaginal delivery, up to 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404776, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.