Clinical trial NCT04233008: Length of Cook Catheter Placement and Induction of Labor
Official title: Length of Cook Catheter Placement and Induction of Labor: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induction of Labor
Keywords: Maternal outcomes
Neonatal Outcomes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 178
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to Delivery
timeFrame: Assessed following delivery (delivery day, day 0)
Secondary outcomes:
measure: Cesarean Delivery Rate
timeFrame: Assessed following delivery (delivery day, day 0)
measure: Time to Active Labor
timeFrame: Assessed following delivery (delivery day, day 0)
measure: Delivery Within 12 Hours
timeFrame: Assessed following delivery (delivery day, day 0)
measure: Delivery Within 24 Hours
timeFrame: Assessed following delivery (delivery day, day 0)
measure: Maternal Length of Stay
timeFrame: Assessed at end of study period (week 4)
measure: Indication for Cesarean Delivery
timeFrame: Assessed following delivery (delivery day, day 0)
measure: Maternal Complications
timeFrame: Assessed at end of study period (week 4)
measure: Neonatal Complications
timeFrame: Assessed at end of study period (week 4)
measure: NICU Admission
timeFrame: Assessed at end of study period (week 4)
measure: NICU Admission >48 Hours
timeFrame: Assessed at end of study period (week 4)
measure: Neonatal Length of Stay
timeFrame: Assessed at end of study period (week 4)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital, Harvard Medical School, Boston MA
name: Sarah E Little, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Battarbee AN, Palatnik A, Peress DA, Grobman WA. Association of Early Amniotomy After Foley Balloon Catheter Ripening and Duration of Nulliparous Labor Induction. Obstet Gynecol. 2016 Sep;128(3):592-597. doi: 10.1097/AOG.0000000000001563.
citation: Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. doi: 10.1002/14651858.CD001233.
citation: Cromi A, Ghezzi F, Agosti M, Serati M, Uccella S, Arlant V, Bolis P. Is transcervical Foley catheter actually slower than prostaglandins in ripening the cervix? A randomized study. Am J Obstet Gynecol. 2011 Apr;204(4):338.e1-7. doi: 10.1016/j.ajog.2010.11.029. Epub 2011 Jan 26.
citation: Hamilton BE, Martin JA, Osterman MJ, Curtin SC, Matthews TJ. Births: Final Data for 2014. Natl Vital Stat Rep. 2015 Dec;64(12):1-64.
citation: Levine LD, Downes KL, Elovitz MA, Parry S, Sammel MD, Srinivas SK. Mechanical and Pharmacologic Methods of Labor Induction: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1357-1364. doi: 10.1097/AOG.0000000000001778.
citation: Lassey SC, Haber HR, Kanbergs A, Robinson JN, Little SE. Six versus twelve hours of single-balloon catheter placement with oxytocin administration for labor induction: a randomized controlled trial. Am J Obstet Gynecol. 2021 Jun;224(6):611.e1-611.e8. doi: 10.1016/j.ajog.2021.03.021. Epub 2021 Mar 23.