Length of Cook Catheter Placement and Induction of Labor

Induction of Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04233008
• Other study ID #: 54321
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: May 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Device:
• Foley catheter length
see arm description

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2001;(4):CD001233. Review. Update in: Cochrane Database Syst Rev. 2012;3:CD001233. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Delivery	Time to delivery	Assessed following delivery (delivery day, day 0)
Secondary	Cesarean Delivery Rate	Cesarean delivery rate	Assessed following delivery (delivery day, day 0)
Secondary	Time to Active Labor	Time to reaching active labor (defined as 5cm)	Assessed following delivery (delivery day, day 0)
Secondary	Delivery Within 12 Hours	The number of women in each group who deliver within 12 hours	Assessed following delivery (delivery day, day 0)
Secondary	Delivery Within 24 Hours	The number of women in each group who deliver within 24 hours	Assessed following delivery (delivery day, day 0)
Secondary	Maternal Length of Stay	Length of hospital stay from start of induction to postpartum discharge	Assessed at end of study period (week 4)
Secondary	Indication for Cesarean Delivery	Number of Patient with Indication for Cesarean Delivery	Assessed following delivery (delivery day, day 0)
Secondary	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)
Secondary	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)
Secondary	NICU Admission	Number of infants admitted to NICU	Assessed at end of study period (week 4)
Secondary	NICU Admission >48 Hours	Number of infants admitted to NICU for >48 hours	Assessed at end of study period (week 4)
Secondary	Neonatal Length of Stay	Days of hospital stay	Assessed at end of study period (week 4)