Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml

• ClinicalTrials.gov Identifier: NCT00451308
• Recruitment Status: Completed
• First Posted: March 23, 2007
• Last Update Posted: August 2, 2013
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: March 22, 2007
• First Posted Date: March 23, 2007
• Last Update Posted Date: August 2, 2013
• Study Start Date: November 2006
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 15, 2008): Rate of vaginal delivery within 24 hours [ Time Frame: within 24 hours ]
• Original Primary Outcome Measures (submitted: March 22, 2007): Rate of vaginal delivery within 24 hours

Current Secondary Outcome Measures (submitted: May 15, 2008)

• Cervical dilation after Foley balloon catheter expulsion [ Time Frame: within 24hours ]
• Time to catheter expulsion [ Time Frame: hours ]
• Duration of the first stage of labor [ Time Frame: hours ]
• Time interval from induction to active labor [ Time Frame: hours ]
• Induction to delivery interval [ Time Frame: hours ]
• Presence of abnormal vaginal bleeding [ Time Frame: hours ]
• Peak oxytocin requirement during induction and labor augmentation [ Time Frame: hours ]
• Epidural utilization, diagnosis of chorioamnionitis [ Time Frame: hours ]
• Meconium stained amniotic fluid, placental abruption [ Time Frame: hours ]
• Cesarean delivery rate, operative vaginal delivery rate [ Time Frame: hours ]
• Indication for operative vaginal or cesarean delivery [ Time Frame: hours ]
• Rate of cervical laceration [ Time Frame: hours ]
• Birthweight [ Time Frame: hours ]
• 5 minute Apgar score [ Time Frame: hours ]
• Umbilical cord arterial blood pH analysis [ Time Frame: hours ]

Original Secondary Outcome Measures (submitted: March 22, 2007)

• Cervical dilation after Foley balloon catheter expulsion
• Time to catheter expulsion
• Duration of the first stage of labor
• Time interval from induction to active labor
• Induction to delivery interval
• Presence of abnormal vaginal bleeding
• Peak oxytocin requirement during induction and labor augmentation
• Epidural utilization, diagnosis of chorioamnionitis
• Meconium stained amniotic fluid, placental abruption
• Cesarean delivery rate, operative vaginal delivery rate
• Indication for operative vaginal or cesarean delivery
• Rate of cervical laceration
• Birthweight
• 5 minute Apgar score
• Umbilical cord arterial blood pH analysis

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml
• Official Title: Induction of Labor With a Foley Catheter Balloon: A Randomized Trial Comparing Inflation With 30ml and 60ml
• Brief Summary: The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley balloon catheter placement is a common method used for labor induction in women with an unfavorable cervical assessment. There are several studies using various volumes of Foley balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no studies replicating the findings of the largest study comparing 2 different volumes in the balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml in a Foley balloon catheter for women undergoing induction of labor with an unfavorable cervix. The investigators will observe the following outcomes: rate of delivery within 24 hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.
• Detailed Description: All potential candidates will be approached for the study and undergo written consent if willing to participate. Each candidate will be randomized to 30ml or 60 ml Foley balloon catheter volume. A random number generator will be used and within a sealed envelope will be placed the assignment. Nulliparous and multiparous patients will be randomized separately. The patient will be positioned for a standard cervical exam - either for digital or speculum exam, depending on the individual patient preference and provider choice. For digital exam, a sterile Foley balloon catheter will be digitally placed in the endocervical canal, into the extraamniotic space (between the fetal head, external to the unruptured amniotic sac, above the internal os of the cervix). For speculum exam, the cervix is wiped three times with a Betadine cleansing solution, and a sterile Foley balloon catheter bulb will be placed under direct visualization into the endocervical canal, into the extraamniotic space. Once the balloon is in place the provider inserts 30ml of sterile saline. The provider then leaves the room. The patient's nurse opens the envelope and if the patient is allocated to the 60ml volume group, the nurse adds an additional 30ml of sterile saline. If the patient is in the 30ml group, the RN staff will simulate placement of additional saline into the foley balloon without actually placing any additional saline in order to also blind the patients to their assigned group. The MD/CNM providers will then return to the room, blinded to the inflation of the Foley balloon, and the balloon catheter will be placed under tension by taping the external end to the patient's inner thigh. Oxytocin will be started within 30 minutes of the Foley balloon catheter placement, using the standard intravenous oxytocin protocol. Additional manual traction on the Foley balloon catheter will be performed every 30 minutes until Foley balloon catheter expulsion. A sterile cervical exam will be performed after spontaneous Foley catheter expulsion to evaluate post-balloon cervical dilation. No further procedures or tests specific to this study will be required beyond this point; only data collection on the above study outcomes during the remaining course of the patient's labor will be recorded.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Induction of Labor

Intervention

• Procedure: Induction of labor with foley balloon - 60cc of saline
  60 cc of fluid
• Procedure: Induction of labor with foley balloon with 30cc
  30cc of saline in foley

Study Arms

• Experimental: 1
  Foley balloon wih 60cc fluid
  Intervention: Procedure: Induction of labor with foley balloon - 60cc of saline
• Active Comparator: 2
  Foley balloon with 30cc
  Intervention: Procedure: Induction of labor with foley balloon with 30cc

• Publications *: Delaney S, Shaffer BL, Cheng YW, Vargas J, Sparks TN, Paul K, Caughey AB. Labor induction with a Foley balloon inflated to 30 mL compared with 60 mL: a randomized controlled trial. Obstet Gynecol. 2010 Jun;115(6):1239-1245. doi: 10.1097/AOG.0b013e3181dec6d0.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 28, 2009): 192
• Original Enrollment (submitted: March 22, 2007): 200
• Actual Study Completion Date: July 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Reproductive aged women, pregnant, term gestation (>37 weeks), undergoing induction of labor, cervical exam acceptable as a candidate for Foley balloon catheter placement (Bishop score <5), cephalic fetal presentation.

Exclusion Criteria:

• Regular contractions on admission, rupture of membranes, previous uterine scar, low-lying placenta (measured <3cm to internal os), Bishop score > 5, contraindication to attempt at vaginal birth, non-English/Spanish speaking, unable to give consent.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00451308
• Other Study ID Numbers: H4114729401-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Aaron B Caughey, MD,PhD; University of California, San Francisco

• PRS Account: University of California, San Francisco
• Verification Date: July 2013