Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

• ClinicalTrials.gov Identifier: NCT02344459
• Recruitment Status: Completed
• First Posted: January 26, 2015
• Last Update Posted: January 26, 2015
• Sponsor: University of Washington
• Information provided by (Responsible Party): Kara Hoppe, University of Washington

Study Description

Brief Summary:

The purpose of this study is to perform a randomized controlled trial to compare the efficacy of 80mL double balloon catheter versus a 30mL single catheter balloon for pre-induction cervical ripening by evaluating the change in Bishop score.

Condition or disease	Intervention/treatment	Phase
Pre-induction Cervical Ripening	Device: mechanical pre-induction cervical ripening	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial: Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening
• Study Start Date: January 2010
• Actual Primary Completion Date: November 2013
• Actual Study Completion Date: November 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 80mL double balloon catheter (Cook catheter®)	Device: mechanical pre-induction cervical ripening; The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.
Active Comparator: 30mL single Foley balloon catheter	Device: mechanical pre-induction cervical ripening; The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.

Outcome Measures

Primary Outcome Measures :

1. Bishop score greater than or equal to 6 at time of balloon catheter removal [ Time Frame: until catheter removal (12 hours maximum) ]

Secondary Outcome Measures :

1. induction to delivery time [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
2. vaginal delivery time less than 24 hours from initiation of induction [ Time Frame: 24 hours ]
3. mode of delivery [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
4. Time to catheter expulsion [ Time Frame: Up to 12 hours ]
5. Type of catheter expulsion [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
   spontaneous vs. provider
6. Epidural utilization [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
7. Meconium stained amniotic fluid [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
8. 5 minute Apgar score [ Time Frame: The participants infant will be monitored from immediately to 5 minutes after birth ]
9. Medication required to augment labor [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
   prostaglandins, oxytocin
10. Artificial rupture of membranes required to augment labor [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
11. Cesarean section indications [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
12. Neonatal intensive care unit admissions [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
13. Chorioamnionitis [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]
14. birthweight [ Time Frame: The participant will be monitored from time of admission until delivery, an expected average of 24-48 hours of the infant (on average 24-48 hours) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Bishop score of 5 or less
• Singleton
• Cephalic presentation
• Fewer than 4 contractions in 10 minutes
• Reactive fetal monitoring

Exclusion Criteria:

• Non-vertex presentation
• Placenta previa
• Vasa previa
• Unexplained vaginal bleeding
• Active herpes simplex virus infection
• Non-English speaking
• Previous attempt at an induction of labor in the current pregnancy
• Prolapsed umbilical cord
• More than one prior cesarean delivery or history of classical cesarean delivery
• Patients receiving or planning to undergo exogenous prostaglandin administration as the primary induction agent

Contacts and Locations

Sponsors and Collaborators

University of Washington

Investigators

• Principal Investigator: Kara K Hoppe, DO; University of Washington

More Information

• Responsible Party: Kara Hoppe, Maternal Fetal Medicine Fellow, University of Washington
• ClinicalTrials.gov Identifier: NCT02344459
• Other Study ID Numbers: 36685-D
• First Posted: January 26, 2015
• Last Update Posted: January 26, 2015
• Last Verified: January 2015