Length of Cook Catheter Placement and Induction of Labor
- Conditions
- Induction of Labor
- Interventions
- Device: Foley catheter length
- Registration Number
- NCT04233008
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 178
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.
- Non English speaking
- Contraindications to vaginal delivery
- Prior cesarean section
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 hour foley Foley catheter length 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.
- Primary Outcome Measures
Name Time Method Time to Delivery Assessed following delivery (delivery day, day 0) Time to delivery
- Secondary Outcome Measures
Name Time Method Time to Active Labor Assessed following delivery (delivery day, day 0) Time to reaching active labor (defined as 5cm)
Delivery Within 12 Hours Assessed following delivery (delivery day, day 0) The number of women in each group who deliver within 12 hours
Delivery Within 24 Hours Assessed following delivery (delivery day, day 0) The number of women in each group who deliver within 24 hours
Indication for Cesarean Delivery Assessed following delivery (delivery day, day 0) Number of Patient with Indication for Cesarean Delivery
NICU Admission Assessed at end of study period (week 4) Number of infants admitted to NICU
Cesarean Delivery Rate Assessed following delivery (delivery day, day 0) Cesarean delivery rate
NICU Admission >48 Hours Assessed at end of study period (week 4) Number of infants admitted to NICU for \>48 hours
Neonatal Length of Stay Assessed at end of study period (week 4) Days of hospital stay
Maternal Length of Stay Assessed at end of study period (week 4) Length of hospital stay from start of induction to postpartum discharge
Neonatal Complications Assessed at end of study period (week 4) culture-proven neonatal sepsis, neonatal blood transfusion, hypoxic-ischemic encephalopathy, intraventricular hemorrhage grade 3 or 4, or therapeutic hypothermia
Maternal Complications Assessed at end of study period (week 4) Estimated blood loss, blood transfusion, higher order laceration, endometritis, wound infection, venous thromboembolism, hysterectomy, ICU admission, maternal death
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States