Length of Cook Catheter Placement and Induction of Labor

Length of Cook Catheter Placement and Induction of Labor: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Induction of Labor
• Intervention / Treatment: Device: Foley catheter length

Detailed Description

Upon presentation to labor and delivery the participant will have a cook catheter inserted digitally or by direct visualization with a speculum. The uterine component of the balloon will be inflated to maximum 60mL. The catheter will be taped to the inner thigh with gentle traction. In both groups participants will be started on hospital-based oxytocin protocol. This protocol beings with 2 milliunits/min of oxytocin, increasing by 2 milliunits every 15 minutes until regular uterine contractions occur. The maximum dose of oxytocin is considered to be 30 milliunits. The cook catheter will then be removed at 6 vs. 12 hours based on randomization. At that point health care providers will manage active labor. Health care providers many perform amniotomy at any point during the induction process with recommendation for amniotomy with cervix more than 4cm dilated. Labor interventions are at the discretion of the healthcare provider. The participants will have continuous fetal monitoring throughout their induction, labor and delivery. Need for operative delivery or cesarean section will be at the discretion of the health provider.

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: Women undergoing cervical ripening for labor induction at term (37-41 6/7 weeks) with a singleton gestation in cephalic presentation. Women will need to have a bishop score <6 or cervical dilation <2cm with intact membranes to be included.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6 hour foley; 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; see arm description
No Intervention: 12 hour foley; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Delivery	Time to delivery	Assessed following delivery (delivery day, day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean Delivery Rate	Cesarean delivery rate	Assessed following delivery (delivery day, day 0)
Time to Active Labor	Time to reaching active labor (defined as 5cm)	Assessed following delivery (delivery day, day 0)
Delivery Within 12 Hours	The number of women in each group who deliver within 12 hours	Assessed following delivery (delivery day, day 0)
Delivery Within 24 Hours	The number of women in each group who deliver within 24 hours	Assessed following delivery (delivery day, day 0)
Maternal Length of Stay	Length of hospital stay from start of induction to postpartum discharge	Assessed at end of study period (week 4)
Indication for Cesarean Delivery	Number of Patient with Indication for Cesarean Delivery	Assessed following delivery (delivery day, day 0)
Maternal Complications	Estimated blood loss, blood transfusion, higher order laceration, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, maternal death	Assessed at end of study period (week 4)
Neonatal Complications	culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia	Assessed at end of study period (week 4)
NICU Admission	Number of infants admitted to NICU	Assessed at end of study period (week 4)
NICU Admission >48 Hours	Number of infants admitted to NICU for >48 hours	Assessed at end of study period (week 4)
Neonatal Length of Stay	Days of hospital stay	Assessed at end of study period (week 4)

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Sarah E Little, MD, Brigham and Women's Hospital, Harvard Medical School, Boston MA

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Maternal outcomes; Neonatal Outcomes
• Other Study ID Numbers: 54321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Research only shared within study staff

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No