Length of Cook Catheter Placement and Induction of Labor

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Induction of Labor

Intervention / Treatment
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* Device: Foley catheter length


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6 hour foley<br>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<br>* see arm description<br>|
| No Intervention: 12 hour foley<br>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?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal outcomes, Neonatal Outcomes