History of Changes for Study: NCT00451308
Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml
Latest version (submitted July 31, 2013) on
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Study Record Versions
Version A B Submitted Date Changes
1 March 22, 2007 None (earliest Version on record)
2 May 15, 2008 Arms and Interventions, Study Design, Study Status, Outcome Measures, Study Description and Sponsor/Collaborators
3 December 28, 2009 Recruitment Status, Study Status, Contacts/Locations, Study Design and Study Description
4 July 31, 2013 Sponsor/Collaborators and Study Status
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Study NCT00451308
Submitted Date:  March 22, 2007 (v1)

Open or close this module Study Identification
Unique Protocol ID: H4114729401-01
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2006
Overall Status: Recruiting
Study Start: November 2006
Primary Completion:
Study Completion: July 2008 [Anticipated]
First Submitted: March 22, 2007
First Submitted that
Met QC Criteria:
March 22, 2007
First Posted: March 23, 2007 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 22, 2007
Last Update Posted: March 23, 2007 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of California, San Francisco
Responsible Party:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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 baloon. We 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. We 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.
Open or close this module Conditions
Conditions: Induction of Labor
Keywords: Induction of labor
vaginal delivery
cesarean section
foley balloon cathether
method of labor induction
perinatal outcomes
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 4
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 200
Open or close this module Arms and Interventions
Intervention Details:
Device: Floey Baloon Catheter, Inflated with 30ml or 60ml
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Rate of vaginal delivery within 24 hours
Secondary Outcome Measures:
1. Cervical dilation after Foley balloon catheter expulsion
2. Time to catheter expulsion
3. Duration of the first stage of labor
4. Time interval from induction to active labor
5. Induction to delivery interval
6. Presence of abnormal vaginal bleeding
7. Peak oxytocin requirement during induction and labor augmentation
8. Epidural utilization, diagnosis of chorioamnionitis
9. Meconium stained amniotic fluid, placental abruption
10. Cesarean delivery rate, operative vaginal delivery rate
11. Indication for operative vaginal or cesarean delivery
12. Rate of cervical laceration
13. Birthweight
14. 5 minute Apgar score
15. Umbilical cord arterial blood pH analysis
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No

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.
Open or close this module Contacts/Locations
Central Contact Person: Aarron B Caughey, MD,PhD
Telephone: 415-514-9322
Central Contact Backup: Shani Delaney, MD
Telephone: 415-476-5192
Study Officials: Aaron B Caughey, MD,PhD
Principal Investigator
University of California, San Francisco
Locations: United States, California
University of California, San Francisco Department of Obstetrics, Gynecology and Reproductive Sciences
San Francisco, California, United States, 94143
Contact:Principal Investigator: Aaron B Caughey, MD, PhD
Contact:Sub-Investigator: Shani Delaney, MD
Contact:Sub-Investigator: Brian L Shaffer, MD
Contact:Sub-Investigator: Juan E Vargas, MD
Contact:Sub-Investigator: Yvonne W Cheng, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Available IPD/Information:

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