Foley CatheterizationNCT02044458
Foley Catheter for Induction of Labor
A study testing Stylette in people with Foley Catheterization and Induction of Labor, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Study Design: Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Detailed Description The utilization of a Foley catheter for induction of labor is well established. There are two techniques readily used for placing a Foley catheter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Foley Catheterization, Induction of Labor, 5 French Stylette
- What is being tested?
- Stylette
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton fetus
- Cephalic presentation
- Indicated or Post-Estimated Date of Confinement
- Induction of labor with a Bishop score < 5
Who cannot join
- Low lying placenta
- Undiagnosed vaginal bleeding
- History of induction or pre-induction agent during the same pregnancy
- Signs or symptoms of infection (i.e. Maternal fever)
- Rupture of membranes
- Multiple gestation
- Women with an urgent or emergent clinical situation in which the medical staff caring for the patient determines that obtaining consent would interfere with the patient's clinical care
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora Sinia Medical Center
Milwaukee, Wisconsin, 53215
About this study
Official title: A Randomized Control Trial of Foley Catheter Placement for Induction of Labor: Stylette Versus no Stylette
Study Design:
Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Read more
Detailed Description
The utilization of a Foley catheter for induction of labor is well established. There are two techniques readily used for placing a Foley catheter. The most common method is under direct visualization of the cervix during a sterile speculum examination and the other method is to place a catheter during a digital cervical examination.
Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The Foley catheter plus rigid stylette technique seems to be an efficient and safe method for labor induction. However, to our knowledge there is no study that assesses the difference between the standard digital placement of a Foley catheter versus the digital placement of a Foley catheter with stylette.
Read the detailed description
Outcomes:
Primary Outcome Measures:
- The duration of insertion between the Foley catheter groups with and without a stylette.
Secondary Outcome Measures:
- Pain assessed by visual analogue scale (VAS), in women randomly allocated to rigid stylette or no rigid stylette placement of a Foley catheter for induction of labor.
Tertiary Outcome Measure:
- Compare the failure rate of the placement of a Foley catheter for induction of labor in women randomly allocated to rigid stylette or no rigid stylette
Design and Methods:
The decision to proceed with induction of labor with Foley catheter will be made by the attending obstetrician caring for the patient. Women requiring induction of labor will be consented to be in the study when the need for induction is confirmed. After obtaining informed consent, the nurse involved in the patient care will be notified of the patient's participation in the study. Random assignment to either a Foley bulb with 5 French stylette versus without will be achieved by the resident physician selecting the next sealed, opaque envelopes containing the assignment information. The envelopes only show the randomization number on the outside. Envelopes will be kept on the Labor and Delivery ward. It will be impossible for the performing physician or the patient to be blinded to the condition of the study due to the instruments needed for the different techniques. The performing physician will be decided prior to the envelop selection and will be the same resident physician who obtained the patient's Bishop Score. A 22 French Foley catheter will be used in both groups of the study. A 5 French stylette (also known as a rigid catheter guide or urethral manipulator used in the TVT procedure) will be used in the group assigned to the stylette.
Pre-induction cervical examination and assessment of Bishop score to be done by an OB/GYN resident physician (PGY 2-4) on the labor and delivery ward. Insertion technique for the Foley bulb with or without the 5 French stylette will be started in the same way. The patient will be placed in the dorsal lithotomy position. The labor bed will be disassembled in the normal fashion as is done for laboring patients with the foot of the bed removed. The patient's feet will then be placed in foot rests. The OB/GYN resident (PGY 2-4) will then perform a vaginal examination to identify the internal os. The Foley catheter, with or without stylette, will then be guided over the examiner's hand and into the endocervix. When the Foley balloon is past the internal os, the balloon will be inflated with 50cc normal saline. The Foley catheter will be placed on gentle traction and taped to the right medial thigh of the patient. Gentle traction will be reapplied every 30-60 minutes with reapplication of the tape to the right medial thigh by the Registered Nurse. This will be continued until expulsion of the Foley balloon or at a maximum duration of 12-24 hours. After expulsion of the Foley balloon, induction of labor will be further carried out with oxytocin infusion and/or with artificial rupture of membranes.. If the Foley catheter is removed at 24 hours status post insertion, the procedure will counted as a failed induction of labor with the Foley catheter and other methods of induction will be continued (i.e. Misoprostol, Artificial rupture or membranes, Oxytocin, etc.).
The time will begin at the start of the vaginal examination for placement of the Foley catheter and end after the balloon has been filled completely with saline.
Timeframe: Participants will be enrolled from April 2013 to January 2014 or until we have successfully enrolled 128 (64 per group) participants in the study. Data will be collected throughout the duration of the study to allow for all information from the hospital stay to be entered in the patient's medical record. Data analysis will occur from January 2014 to February 2014. Data presentation could occur up to 2 years after the complete of the study.
Data Collection:
The following variables will be recorded: Age; Race (0=NA; 1=Caucasian; 2=African American/Black; 3=Hispanic; 4=Asian 5=Other); BMI; Gravidity and Parity; Gestational Age; Reason for Indication for Induction (0=NA; 1=Post-term pregnancy; 2=Spontaneous Rupture of the Membranes; 3=Maternal disease; 4=Fetal indications; 5=Psychosocial parameters; 6= In vitro fertilization; 7=Advanced maternal age; 8 Maternal Request; 9=Other); History of Previous Cesarean Deliveries; Diabetes mellitus (0=NA; 1=Type I; 2=Type II; 3=Prediabetes; 4=GDM); Hypertensive disorders (0=NA; 1=Chronic HTN; 2= Gestational HTN; 3=Mild Preeclampsia; 4=Severe Preeclampsia; 5=Eclampsia); Renal Disease (0=No; 1=Yes); Other Comorbidities (0=No; 1=Yes); Documented Chorioamnionitis (0=No; 1=Yes); Epidural (0=No; 1=Yes); Inadvertent Rupture of Membranes (0=No; 1=Yes); Type of Delivery; Pain Assessment (0-10); Patient Satisfaction; Type of Delivery.
Points of time recorded will be: Time of insertion (Placement of Foley catheter); Time of expulsion of catheter; Time taken to place catheter; Time oxytocin started; Time oxytocin ended; Duration of treatment (Insertion to expulsion); Duration of induction (induction to delivery); Duration of oxytocin.
All variables will be recorded on an Excel spreadsheet by the resident physician or study coordinator. See attached example.
- Conditions
- Foley Catheterization, Induction of Labor, 5 French Stylette
- Being tested
- Stylette
- Keywords
- Foley Catheterization, Induction of Labor, 5 French Stylette
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StyletteDevice
Also called 5 French stylette, Rigid catheter guide, Urethral manipulator (TVT procedure)
use of stylette for successful insertion of foley catheter for induction of labor
| Study group | Role | What they receive |
|---|---|---|
| Stylette | Active comparator | Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Receives: Device: Stylette |
| No Stylette | No intervention | No Stylette: 22 French Foley catheter placed without stylette or guide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.
Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).
Measured: Followed throughout patient's hospital stay, approximately 10 days
Secondary outcomes (1)
Pain Assessed by Visual Analog Scale (VAS)
To compare the pain assessed by visual analogue scale(VAS), in women randomly allocated to ridged stylette or no ridged stylette. Patient-assessed pain level was determined by verbally asking patients to assess their pain (on a scale from 0-10 [no pain-worst pain]) following taping of the catheter tail. Pain was only assessed once.
Measured: Followed throughout patient's hospital stay, approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Foley CatheterizationStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danish S Siddiqui, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044458
- Sponsor's protocol ID
- #13-46E :Foley Catheter
- Status last verified
- Mar 2024
- First submitted
- 9 Jul 2013
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Foley Catheter Placement for Induction of Labor: Stylette Versus no Stylette
- ClinicalTrials.gov ID
- NCT02044458
- Acronym / sponsor ID
- #13-46E :Foley Catheter
- Conditions
- Foley Catheterization, Induction of Labor, 5 French Stylette
- Keywords
- Foley Catheterization, Induction of Labor, 5 French Stylette
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Posted 26 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design:
Allocation: 2 arms Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Detailed Description
The utilization of a Foley catheter for induction of labor is well established. There are two techniques readily used for placing a Foley catheter. The most common method is under direct visualization of the cervix during a sterile speculum examination and the other method is to place a catheter during a digital cervical examination.
Studies have reported the use of a rigid stylette (a thin wire inserted into a catheter to maintain rigidity) to guide the insertion of the Foley catheter decreases failure rate. The Foley catheter plus rigid stylette technique seems to be an efficient and safe method for labor induction. However, to our knowledge there is no study that assesses the difference between the standard digital placement of a Foley catheter versus the digital placement of a Foley catheter with stylette.
Detailed description
Outcomes:
Primary Outcome Measures:
- The duration of insertion between the Foley catheter groups with and without a stylette.
Secondary Outcome Measures:
- Pain assessed by visual analogue scale (VAS), in women randomly allocated to rigid stylette or no rigid stylette placement of a Foley catheter for induction of labor.
Tertiary Outcome Measure:
- Compare the failure rate of the placement of a Foley catheter for induction of labor in women randomly allocated to rigid stylette or no rigid stylette
Design and Methods:
The decision to proceed with induction of labor with Foley catheter will be made by the attending obstetrician caring for the patient. Women requiring induction of labor will be consented to be in the study when the need for induction is confirmed. After obtaining informed consent, the nurse involved in the patient care will be notified of the patient's participation in the study. Random assignment to either a Foley bulb with 5 French stylette versus without will be achieved by the resident physician selecting the next sealed, opaque envelopes containing the assignment information. The envelopes only show the randomization number on the outside. Envelopes will be kept on the Labor and Delivery ward. It will be impossible for the performing physician or the patient to be blinded to the condition of the study due to the instruments needed for the different techniques. The performing physician will be decided prior to the envelop selection and will be the same resident physician who obtained the patient's Bishop Score. A 22 French Foley catheter will be used in both groups of the study. A 5 French stylette (also known as a rigid catheter guide or urethral manipulator used in the TVT procedure) will be used in the group assigned to the stylette.
Pre-induction cervical examination and assessment of Bishop score to be done by an OB/GYN resident physician (PGY 2-4) on the labor and delivery ward. Insertion technique for the Foley bulb with or without the 5 French stylette will be started in the same way. The patient will be placed in the dorsal lithotomy position. The labor bed will be disassembled in the normal fashion as is done for laboring patients with the foot of the bed removed. The patient's feet will then be placed in foot rests. The OB/GYN resident (PGY 2-4) will then perform a vaginal examination to identify the internal os. The Foley catheter, with or without stylette, will then be guided over the examiner's hand and into the endocervix. When the Foley balloon is past the internal os, the balloon will be inflated with 50cc normal saline. The Foley catheter will be placed on gentle traction and taped to the right medial thigh of the patient. Gentle traction will be reapplied every 30-60 minutes with reapplication of the tape to the right medial thigh by the Registered Nurse. This will be continued until expulsion of the Foley balloon or at a maximum duration of 12-24 hours. After expulsion of the Foley balloon, induction of labor will be further carried out with oxytocin infusion and/or with artificial rupture of membranes.. If the Foley catheter is removed at 24 hours status post insertion, the procedure will counted as a failed induction of labor with the Foley catheter and other methods of induction will be continued (i.e. Misoprostol, Artificial rupture or membranes, Oxytocin, etc.).
The time will begin at the start of the vaginal examination for placement of the Foley catheter and end after the balloon has been filled completely with saline.
Timeframe: Participants will be enrolled from April 2013 to January 2014 or until we have successfully enrolled 128 (64 per group) participants in the study. Data will be collected throughout the duration of the study to allow for all information from the hospital stay to be entered in the patient's medical record. Data analysis will occur from January 2014 to February 2014. Data presentation could occur up to 2 years after the complete of the study.
Data Collection:
The following variables will be recorded: Age; Race (0=NA; 1=Caucasian; 2=African American/Black; 3=Hispanic; 4=Asian 5=Other); BMI; Gravidity and Parity; Gestational Age; Reason for Indication for Induction (0=NA; 1=Post-term pregnancy; 2=Spontaneous Rupture of the Membranes; 3=Maternal disease; 4=Fetal indications; 5=Psychosocial parameters; 6= In vitro fertilization; 7=Advanced maternal age; 8 Maternal Request; 9=Other); History of Previous Cesarean Deliveries; Diabetes mellitus (0=NA; 1=Type I; 2=Type II; 3=Prediabetes; 4=GDM); Hypertensive disorders (0=NA; 1=Chronic HTN; 2= Gestational HTN; 3=Mild Preeclampsia; 4=Severe Preeclampsia; 5=Eclampsia); Renal Disease (0=No; 1=Yes); Other Comorbidities (0=No; 1=Yes); Documented Chorioamnionitis (0=No; 1=Yes); Epidural (0=No; 1=Yes); Inadvertent Rupture of Membranes (0=No; 1=Yes); Type of Delivery; Pain Assessment (0-10); Patient Satisfaction; Type of Delivery.
Points of time recorded will be: Time of insertion (Placement of Foley catheter); Time of expulsion of catheter; Time taken to place catheter; Time oxytocin started; Time oxytocin ended; Duration of treatment (Insertion to expulsion); Duration of induction (induction to delivery); Duration of oxytocin.
All variables will be recorded on an Excel spreadsheet by the resident physician or study coordinator. See attached example.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stylette | Active comparator | Device: StyletteStylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. |
| No Stylette | No intervention | –No Stylette: 22 French Foley catheter placed without stylette or guide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Singleton fetus
- Cephalic presentation
- Indicated or Post-Estimated Date of Confinement
- Induction of labor with a Bishop score < 5
Key exclusion criteria (7 listed)
- Low lying placenta
- Undiagnosed vaginal bleeding
- History of induction or pre-induction agent during the same pregnancy
- Signs or symptoms of infection (i.e. Maternal fever)
- Rupture of membranes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StyletteAlso: 5 French stylette, Rigid catheter guide, Urethral manipulator (TVT procedure)use of stylette for successful insertion of foley catheter for induction of labor | Device | Stylette |
Primary outcome
Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.
Time frame: Followed throughout patient's hospital stay, approximately 10 days
Difference in insertion times between women randomly allocated to ridged stylette or no ridged stylette. Patient's may have experienced multiple insertions only if a patient failed initial randomized insertion method. Subsequent treatment methods were used when a patient failed and time was summarized as length of time of attempt. Failure was defined as either inadvertent amniotomy, excessive time in placement (subjectively determined by the provider using the catheter), or excessive patient pain (subjectively defined by the provider but based on patient response).
1 secondary outcome
Pain Assessed by Visual Analog Scale (VAS)
Time frame: Followed throughout patient's hospital stay, approximately 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danish S Siddiqui, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stylette in people with Foley Catheterization and Induction of Labor, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Insertion Between Foley Catheter Groups With and Without a Stylette. (time frame: Followed throughout patient's hospital stay, approximately 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02044458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.