- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00451308
Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml
July 31, 2013 updated by: University of California, San Francisco
Induction of Labor With a Foley Catheter Balloon: A Randomized Trial Comparing Inflation With 30ml and 60ml
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
192
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco Department of Obstetrics, Gynecology and Reproductive Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Foley balloon wih 60cc fluid
|
60 cc of fluid
|
Active Comparator: 2
Foley balloon with 30cc
|
30cc of saline in foley
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of vaginal delivery within 24 hours
Time Frame: within 24 hours
|
within 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cervical dilation after Foley balloon catheter expulsion
Time Frame: within 24hours
|
within 24hours
|
Time to catheter expulsion
Time Frame: hours
|
hours
|
Duration of the first stage of labor
Time Frame: hours
|
hours
|
Time interval from induction to active labor
Time Frame: hours
|
hours
|
Induction to delivery interval
Time Frame: hours
|
hours
|
Presence of abnormal vaginal bleeding
Time Frame: hours
|
hours
|
Peak oxytocin requirement during induction and labor augmentation
Time Frame: hours
|
hours
|
Epidural utilization, diagnosis of chorioamnionitis
Time Frame: hours
|
hours
|
Meconium stained amniotic fluid, placental abruption
Time Frame: hours
|
hours
|
Cesarean delivery rate, operative vaginal delivery rate
Time Frame: hours
|
hours
|
Indication for operative vaginal or cesarean delivery
Time Frame: hours
|
hours
|
Rate of cervical laceration
Time Frame: hours
|
hours
|
Birthweight
Time Frame: hours
|
hours
|
5 minute Apgar score
Time Frame: hours
|
hours
|
Umbilical cord arterial blood pH analysis
Time Frame: hours
|
hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aaron B Caughey, MD,PhD, University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
March 22, 2007
First Submitted That Met QC Criteria
March 22, 2007
First Posted (Estimate)
March 23, 2007
Study Record Updates
Last Update Posted (Estimate)
August 2, 2013
Last Update Submitted That Met QC Criteria
July 31, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H4114729401-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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