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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
see arm description
Brigham and Women's Hospital
Boston, Massachusetts, United States
Time to Delivery
Time to delivery
Time frame: Assessed following delivery (delivery day, day 0)
Cesarean Delivery Rate
Cesarean delivery rate
Time frame: Assessed following delivery (delivery day, day 0)
Time to Active Labor
Time to reaching active labor (defined as 5cm)
Time frame: Assessed following delivery (delivery day, day 0)
Delivery Within 12 Hours
The number of women in each group who deliver within 12 hours
Time frame: Assessed following delivery (delivery day, day 0)
Delivery Within 24 Hours
The number of women in each group who deliver within 24 hours
Time frame: Assessed following delivery (delivery day, day 0)
Maternal Length of Stay
Length of hospital stay from start of induction to postpartum discharge
Time frame: Assessed at end of study period (week 4)
Indication for Cesarean Delivery
Number of Patient with Indication for Cesarean Delivery
Time frame: 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
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Time frame: 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
Time frame: Assessed at end of study period (week 4)
NICU Admission
Number of infants admitted to NICU
Time frame: Assessed at end of study period (week 4)
NICU Admission >48 Hours
Number of infants admitted to NICU for \>48 hours
Time frame: Assessed at end of study period (week 4)
Neonatal Length of Stay
Days of hospital stay
Time frame: Assessed at end of study period (week 4)