Foley Catheter for Induction of Labor

• Sponsor: Marie Forgie (Other)
• Overall Status: Completed
• CT.gov ID: NCT02044458
• Collaborator: Aurora Health Care (Other)
• Enrollment: 134
• Location: 1
• Arms: 2
• Duration (Months): 32
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Foley Catheterization; Induction of Labor; 5 French Stylette	Device: Stylette	N/A

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

• Study Type: Interventional
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Control Trial of Foley Catheter Placement for Induction of Labor: Stylette Versus no Stylette
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stylette Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.	Device: Stylette; use of stylette for successful insertion of foley catheter for induction of labor; Other Names: 5 French stylette Rigid catheter guide Urethral manipulator (TVT procedure)
No Intervention: No Stylette No Stylette: 22 French Foley catheter placed without stylette or guide.

Outcome Measures

Primary Outcome Measures

1. Duration of Insertion Between Foley Catheter Groups With and Without a Stylette. [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).

Secondary Outcome Measures

1. Pain Assessed by Visual Analog Scale (VAS) [Followed throughout patient's hospital stay, approximately 10 days]

   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.

Other Outcome Measures

1. Failure Rates of the Placement of a Foley Catheter [Followed throughout patient's hospital stay, approximately 10 days]

   To compare the failure rate of the placement of a Foley catheter for the induction of labor in women randomly allocated to rigid stylette or no stylette

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Singleton fetus

• Cephalic presentation

• Indicated or Post-Estimated Date of Confinement

• Induction of labor with a Bishop score < 5

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aurora Sinia Medical Center	Milwaukee	Wisconsin	United States	53215

Sponsors and Collaborators

• Marie Forgie
• Aurora Health Care

Investigators

• Principal Investigator: Danish S Siddiqui, MD, Aurora Health Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marie Forgie, DO, Clinical Adjunct Professor- Department of Obstetrics and Gynecology, University of Wisconsin School of Medicine and Public Health, Aurora Sinai Medical Center, Department of Obstetrics and Gynecology, Women's Health Center, Aurora Health Care
• ClinicalTrials.gov Identifier: NCT02044458
• Other Study ID Numbers: #13-46E :Foley Catheter
• First Posted: Jan 24, 2014
• Last Update Posted: May 14, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Marie Forgie, DO, Clinical Adjunct Professor- Department of Obstetrics and Gynecology, University of Wisconsin School of Medicine and Public Health, Aurora Sinai Medical Center, Department of Obstetrics and Gynecology, Women's Health Center, Aurora Health Care: Foley Catheterization; Induction of Labor; 5 French Stylette

Study Results

Participant Flow

Arm/Group Title	Stylette	No Stylette
Arm/Group Description	Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette: 22 French Foley catheter placed without stylette or guide.
Period Title: Overall Study
STARTED	65	69
COMPLETED	62	61
NOT COMPLETED	3	8

Baseline Characteristics

Arm/Group Title	Stylette	No Stylette	Total
Arm/Group Description	Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette: 22 French Foley catheter placed without stylette or guide.	Total of all reporting groups
Overall Participants	62	61	123
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26.9 (5.56)	26.9 (6.98)	26.9 (6.28)
Sex: Female, Male (Count of Participants)
Female	62 100%	61 100%	123 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
White non-Hispanic	15 24.2%	8 13.1%	23 18.7%
African-American non-Hispanic	38 61.3%	41 67.2%	79 64.2%
Hispanic/Latina	6 9.7%	10 16.4%	16 13%
Other	3 4.8%	2 3.3%	5 4.1%
Region of Enrollment (participants) [Number]
United States	62 100%	61 100%	123 100%

Outcome Measures

1. Primary Outcome

Title	Duration of Insertion Between Foley Catheter Groups With and Without a Stylette.
Description	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).
Time Frame	Followed throughout patient's hospital stay, approximately 10 days

Outcome Measure Data

Analysis Population Description

The insertion time of two failed attempts with no stylette were not recorded.

Arm/Group Title	Stylette	No Stylette
Arm/Group Description	Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette: 22 French Foley catheter placed without stylette or guide.
Measure Participants	62	59
Successful insertion attempts	1.72	1.88
Failed insertion attempts	6.55	5.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stylette
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.70
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Pain Assessed by Visual Analog Scale (VAS)
Description	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.
Time Frame	Followed throughout patient's hospital stay, approximately 10 days

Outcome Measure Data

Analysis Population Description

The pain level of one successful attempt with stylette was not recorded.

Arm/Group Title	Stylette	No Stylette
Arm/Group Description	Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette: 22 French Foley catheter placed without stylette or guide.
Measure Participants	61	61
Mean (95% Confidence Interval) [units on a scale]	4.90	4.43

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stylette
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.38
	Comments
	Method	t-test, 2 sided
	Comments

3. Other Pre-specified Outcome

Title	Failure Rates of the Placement of a Foley Catheter
Description	To compare the failure rate of the placement of a Foley catheter for the induction of labor in women randomly allocated to rigid stylette or no stylette
Time Frame	Followed throughout patient's hospital stay, approximately 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stylette	No Stylette
Arm/Group Description	Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor	No Stylette: 22 French Foley catheter placed without stylette or guide.
Measure Participants	62	61
Number [failed attempt]	7	9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Stylette
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.57
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	Study Duration; June 2013-December 2014 (1 year, 6 months)
Adverse Event Reporting Description	Serious and other adverse events were collected and assessed, but none were observed.
Arm/Group Title	Stylette		No Stylette
Arm/Group Description	Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter. Stylette: use of stylette for successful insertion of foley catheter for induction of labor		No Stylette: 22 French Foley catheter placed without stylette or guide.
All Cause Mortality
	Stylette		No Stylette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Stylette		No Stylette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/69 (0%)
Other (Not Including Serious) Adverse Events
	Stylette		No Stylette
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/69 (0%)

Limitations/Caveats

Did not enroll enough subjects to achieve sufficient power for every test performed or to study outcomes with low event rates. Insertion time and failure may be influenced by providers comfort with insertion technique. Women were from a single site.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.