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

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

Tracking Information
First Submitted Date  ICMJE March 22, 2007
First Posted Date  ICMJE March 23, 2007
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE November 2006
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
Rate of vaginal delivery within 24 hours [ Time Frame: within 24 hours ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2007)
Rate of vaginal delivery within 24 hours
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Induction of Labor
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 28, 2009)
192
Original Enrollment  ICMJE
 (submitted: March 22, 2007)
200
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00451308
Other Study ID Numbers  ICMJE H4114729401-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of California, San Francisco
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aaron B Caughey, MD,PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP