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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00451308
First received: March 22, 2007
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Induction of Labor
Procedure: Induction of labor with foley balloon - 60cc of saline
Procedure: Induction of labor with foley balloon with 30cc
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Induction of Labor With a Foley Catheter Balloon: A Randomized Trial Comparing Inflation With 30ml and 60ml

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Rate of vaginal delivery within 24 hours [ Time Frame: within 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cervical dilation after Foley balloon catheter expulsion [ Time Frame: within 24hours ] [ Designated as safety issue: No ]
  • Time to catheter expulsion [ Time Frame: hours ] [ Designated as safety issue: No ]
  • Duration of the first stage of labor [ Time Frame: hours ] [ Designated as safety issue: No ]
  • Time interval from induction to active labor [ Time Frame: hours ] [ Designated as safety issue: No ]
  • Induction to delivery interval [ Time Frame: hours ] [ Designated as safety issue: No ]
  • Presence of abnormal vaginal bleeding [ Time Frame: hours ] [ Designated as safety issue: Yes ]
  • Peak oxytocin requirement during induction and labor augmentation [ Time Frame: hours ] [ Designated as safety issue: No ]
  • Epidural utilization, diagnosis of chorioamnionitis [ Time Frame: hours ] [ Designated as safety issue: No ]
  • Meconium stained amniotic fluid, placental abruption [ Time Frame: hours ] [ Designated as safety issue: Yes ]
  • Cesarean delivery rate, operative vaginal delivery rate [ Time Frame: hours ] [ Designated as safety issue: No ]
  • Indication for operative vaginal or cesarean delivery [ Time Frame: hours ] [ Designated as safety issue: No ]
  • Rate of cervical laceration [ Time Frame: hours ] [ Designated as safety issue: Yes ]
  • Birthweight [ Time Frame: hours ] [ Designated as safety issue: No ]
  • 5 minute Apgar score [ Time Frame: hours ] [ Designated as safety issue: Yes ]
  • Umbilical cord arterial blood pH analysis [ Time Frame: hours ] [ Designated as safety issue: Yes ]

Enrollment: 192
Study Start Date: November 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Foley balloon wih 60cc fluid
Procedure: Induction of labor with foley balloon - 60cc of saline
60 cc of fluid
Active Comparator: 2
Foley balloon with 30cc
Procedure: Induction of labor with foley balloon with 30cc
30cc of saline in foley

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451308

Locations
United States, California
University of California, San Francisco Department of Obstetrics, Gynecology and Reproductive Sciences
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Aaron B Caughey, MD,PhD University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00451308     History of Changes
Other Study ID Numbers: H4114729401-01
Study First Received: March 22, 2007
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Induction of labor
vaginal delivery
cesarean section
foley balloon cathether
method of labor induction
perinatal outcomes

ClinicalTrials.gov processed this record on September 16, 2014