NCT04233008

Length of Cook Catheter Placement and Induction of Labor

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Induction of Labor

Interventions

Type	Name	Description
DEVICE	Foley catheter length	see arm description

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2020-01-18
• Last updated: 2022-06-24
• Results posted: 2022-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study