Brigham and Women's Hospital
Boston, Massachusetts, 02116, United States
NCT Number: NCT04233008
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.
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Boston, Massachusetts, 02116, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
see arm description
Time frame: Assessed following delivery (delivery day, day 0)
Time to delivery
Time frame: Assessed following delivery (delivery day, day 0)
Cesarean delivery rate
Time frame: Assessed following delivery (delivery day, day 0)
Time to reaching active labor (defined as 5cm)
Time frame: Assessed following delivery (delivery day, day 0)
The number of women in each group who deliver within 12 hours
Time frame: Assessed following delivery (delivery day, day 0)
The number of women in each group who deliver within 24 hours
Time frame: Assessed at end of study period (week 4)
Length of hospital stay from start of induction to postpartum discharge
Time frame: Assessed following delivery (delivery day, day 0)
Number of Patient with Indication for Cesarean Delivery
Time frame: 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
Time frame: 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
Time frame: Assessed at end of study period (week 4)
Number of infants admitted to NICU
Time frame: Assessed at end of study period (week 4)
Number of infants admitted to NICU for >48 hours
Time frame: Assessed at end of study period (week 4)
Days of hospital stay
Brigham and Women's Hospital
Other
Length of Cook Catheter Placement and Induction of Labor: a Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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