Foley Catheter for Induction of Labor
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2013 |
| End Date: | December 2015 |
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
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.
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.
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.
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.
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
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