Outpatient Labor Induction With the Transcervical Foley Balloon
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | March 2014 |
| Contact: | Patrick M Mullin, MD |
| Email: | pmullin@usc.edu |
Outpatient Labor Induction With the Transcervical Foley Balloon: A Randomized Trial Comparing Outpatient Immediate Removal Foley Versus Standard Inpatient Foley Induction
This study represents the first randomized trial comparing traditional inpatient induction
with a transcervical foley catheter versus outpatient induction with immediate removal of a
transcervical foley catheter. The immediate removal technique allows the induction process
to begin in the hospital setting, but allows the patient to go home without a foreign body
in situ. The investigators hypothesize the outpatient group will spend less time
hospitalized prior to discharge. Additionally, the investigators will explore the vaginal
delivery rates and maternal/neonatal safety profiles between groups.
with a transcervical foley catheter versus outpatient induction with immediate removal of a
transcervical foley catheter. The immediate removal technique allows the induction process
to begin in the hospital setting, but allows the patient to go home without a foreign body
in situ. The investigators hypothesize the outpatient group will spend less time
hospitalized prior to discharge. Additionally, the investigators will explore the vaginal
delivery rates and maternal/neonatal safety profiles between groups.
This is a randomized controlled trial.
Patients who are candidates for labor induction and meet inclusion criteria will be
identified in the obstetrics clinic when they are being scheduled for induction of labor, or
at a later clinic date. If they agree to participate, patients will be randomized and
enrolled in the study at that time. Those who consent will be randomized into Group A
(Experimental Group) and Group B (Control Group). No stratification criteria will be used.
Patients randomized to the control group will undergo induction of labor using the standard
foley bulb and Pitocin method. Participants will be placed in the dorsal lithotomy position,
an 18 French Foley catheter will be placed transcervically and its balloon filled with 60mL
of sterile saline. One of two methods will be used to place the transcervical foley based on
provider preference and determination of which method will offer the greatest chance for
successful placement. Method A is placement of the foley "blindly" by palpation of the
cervix. Method B utilizes direct visualization with sterile speculum placement. Method will
be documented in the data collection forms. The catheter will be left in place and IV
oxytocin will be started per protocol. The foley catheter will be removed after 12 hours if
not spontaneously extruded.
Patients randomized to the experimental group will undergo outpatient induction of labor.
Either of the above two described methods will be used to place an 18 French Foley catheter
transcervically and its balloon filled with 60mL of sterile saline. The catheter will be
deflated and removed within 10 minutes of placement. The patient will then undergo a
non-stress test (NST). If the patient has a reactive NST with no late or variable
decelerations or uterine tachysystole, the patient will be discharged home with clear return
precautions and instructions to return to the triage area in 24 hours. When the patient
returns to the hospital, a sterile vaginal exam will be done and Bishop score documented.
The patient will then be admitted to L&D for inpatient continuation of induction with IV
oxytocin per protocol.
In accordance with the Friedman curve and current LAC+USC practice, primigravid participants
will be given 20 hours of maximum Pitocin (22 mU/ min) to achieve active labor and
multigravid participants will be given 14 hours before a failed induction is diagnosed.
Cesarean delivery will be recommended for arrest of dilation, arrest of descent, or any
obstetric indication as decided by the on-duty house staff. Finally, at patient request,
intravenous or regional anesthesia will be made available at any time during the labor and
delivery process.
Patients who are candidates for labor induction and meet inclusion criteria will be
identified in the obstetrics clinic when they are being scheduled for induction of labor, or
at a later clinic date. If they agree to participate, patients will be randomized and
enrolled in the study at that time. Those who consent will be randomized into Group A
(Experimental Group) and Group B (Control Group). No stratification criteria will be used.
Patients randomized to the control group will undergo induction of labor using the standard
foley bulb and Pitocin method. Participants will be placed in the dorsal lithotomy position,
an 18 French Foley catheter will be placed transcervically and its balloon filled with 60mL
of sterile saline. One of two methods will be used to place the transcervical foley based on
provider preference and determination of which method will offer the greatest chance for
successful placement. Method A is placement of the foley "blindly" by palpation of the
cervix. Method B utilizes direct visualization with sterile speculum placement. Method will
be documented in the data collection forms. The catheter will be left in place and IV
oxytocin will be started per protocol. The foley catheter will be removed after 12 hours if
not spontaneously extruded.
Patients randomized to the experimental group will undergo outpatient induction of labor.
Either of the above two described methods will be used to place an 18 French Foley catheter
transcervically and its balloon filled with 60mL of sterile saline. The catheter will be
deflated and removed within 10 minutes of placement. The patient will then undergo a
non-stress test (NST). If the patient has a reactive NST with no late or variable
decelerations or uterine tachysystole, the patient will be discharged home with clear return
precautions and instructions to return to the triage area in 24 hours. When the patient
returns to the hospital, a sterile vaginal exam will be done and Bishop score documented.
The patient will then be admitted to L&D for inpatient continuation of induction with IV
oxytocin per protocol.
In accordance with the Friedman curve and current LAC+USC practice, primigravid participants
will be given 20 hours of maximum Pitocin (22 mU/ min) to achieve active labor and
multigravid participants will be given 14 hours before a failed induction is diagnosed.
Cesarean delivery will be recommended for arrest of dilation, arrest of descent, or any
obstetric indication as decided by the on-duty house staff. Finally, at patient request,
intravenous or regional anesthesia will be made available at any time during the labor and
delivery process.
Inclusion Criteria:
- Viable Intrauterine Pregnancy
- Greater than or equal to 37 weeks gestation on date of induction
- Cephalic Presentation
- Medically indicated induction of labor
- AFI greater than or equal to 5
- Patient able to be contacted by phone and demonstrates an understanding of the return
instructions
- Cervical Dilation 2cm or less
Exclusion Criteria:
- Placenta Previa/Low Lying Placenta
- Placenta accreta/increta/percreta
- Undiagnosed vaginal bleeding
- Preeclampsia or HELLP Syndrome
- Intrauterine Growth Restriction
- Rupture of Membranes
- Prior cesarean section or transfundal uterine surgery
- Twin Gestation
- Fetal Anomaly
- Rh Isoimmunization
- Fetal Demise
- Uterine Tachysystole
- Less than 18 years of age
- HIV Infection
- Active herpes, hepatitis B or C infection
- Latex Allergy
- EFW>4000g
- Chorioamnionitis
- Non-English or Non-Spanish Speaking
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