Length of Cook Catheter Placement and Induction of Labor

NCT04233008 | Completed Results DMC FDA Device

• 1 other identifier: 54321
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to compare cook catheter placement for 6 vs. 12 hours to see if there is faster time to delivery for people admitted to labor and delivery undergoing induction of labor.

Conditions

Induction of Labor

Keywords

Maternal outcomes; Neonatal Outcomes

Outcome Measures

Primary Outcomes (1)

• Time to Delivery

  Time to delivery

  Assessed following delivery (delivery day, day 0)

Secondary Outcomes (11)

• Cesarean Delivery Rate

  Assessed following delivery (delivery day, day 0)

• Time to Active Labor

  Assessed following delivery (delivery day, day 0)

• Delivery Within 12 Hours

  Assessed following delivery (delivery day, day 0)

• Delivery Within 24 Hours

  Assessed following delivery (delivery day, day 0)

• Maternal Length of Stay

  Assessed at end of study period (week 4)

Study Arms (2)

6 hour foley

EXPERIMENTAL

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.

Device: Foley catheter length

12 hour foley

NO INTERVENTION

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.

Interventions

Foley catheter length DEVICE

see arm description

6 hour foley

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Non English speaking
• Contraindications to vaginal delivery
• Prior cesarean section

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02116, United States

Location

Related Publications (6)

• 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.

  PMID: 27500341 BACKGROUND

• 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.

  PMID: 11687101 BACKGROUND

• 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.

  PMID: 21272849 BACKGROUND

• 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.

  PMID: 26727629 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

• 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.

  PMID: 33771496 DERIVED

Results Point of Contact

• Title: Sarah Little
• Organization: Brigham and Women's Hospital

selittle@bwh.harvard.edu

617-732-5452

Study Officials

• Sarah E Little, MD

  Brigham and Women's Hospital, Harvard Medical School, Boston MA

  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: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: January 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 24, 2022
• Results First Posted: June 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)