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Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)

Primary Purpose

Labor Pain, Complications; Cesarean Section, Pregnancy

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Epidural anesthesia
Combined spinal and epidural anesthesia
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring trial of labor after cesarean, vaginal birth after cesarean, epidural vs combined spinal epidural

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • all patients meeting ACOG guidelines for TOLAC
  • at least one previous elective cesarean delivery
  • <40 weeks gestational age (GA)
  • vertex singleton pregnancy with use of continuous fetal monitoring

Exclusion Criteria:

  • Patient refusal of regional anesthetic or with contraindication for regional anesthesia
  • BMI >40
  • associated comorbidities such as gestational diabetes, preeclampsia, abnormal placentation

Sites / Locations

  • Lyndon B. Johnson Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Epidural anesthesia

Combined spinal and epidural anesthesia

Arm Description

Trial of labor after cesarean with an epidural for anesthesia: Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.

Trial of labor after cesarean with a combined spinal and epidural (CSE) for anesthesia: the epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.

Outcomes

Primary Outcome Measures

Number of Participants With Vaginal Birth After Cesarean (VBAC)

Secondary Outcome Measures

Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Childbirth Experience as Assessed by a Visual Analogue Scale (VAS)
Childbirth experience was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a better childbirth experience.
Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS)
Maternal Satisfaction was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of satisfaction.
Neonatal Outcome as Assessed by (APGAR) Score
Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Neonatal Outcome as Assessed by (APGAR) Score
Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Time From Regional Anesthesia to Delivery
Time From Second Stage of Labor to Delivery
The second stage of delivery begins after the cervix has dilated to 10 centimeters (cm).

Full Information

First Posted
April 2, 2014
Last Updated
June 22, 2018
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02105558
Brief Title
Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)
Official Title
Outcomes of Epidural Versus Combined Spinal and Epidural (CSE) Anesthetic Technique on the Success of Trial of Labor After Cesarean (TOLAC): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 13, 2017 (Actual)
Study Completion Date
April 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on the success of Trial of Labor After Cesarean (TOLAC).
Detailed Description
Though it has been said, "once a cesarean, always a cesarean," the current medical stance has changed and now encourages vaginal birth after cesaren (VBAC) in a select population of patients. VBAC has several advantages over a repeat cesarean including decreased recovery period, decreased risk of infection, avoidance of major abdominal surgery, and lessened blood loss. Predictors for success of VBAC include previous spontaneous vaginal birth, singleton pregnancy, and previous low transverse scar for C-section delivery. TOLAC is a reasonable option for select pregnant women and is associated with a 74% likelihood of VBAC. Risk factors for failure of VBAC include labor dystocia, advanced maternal age, maternal obesity, fetal macrosomia, gestational age (GA) >40 weeks, short inter pregnancy interval, and preeclampsia. While success of VBAC is associated with fewer complications, failure of VBAC may be associated with increased complications. A major concern for VBAC is the possibility for uterine rupture, which may result in hysterectomy and intrapartum fetal hypoxia/death. According to the American College of Obstetricians and Gynecologists (ACOG) guidelines, effective regional analgesia should not be expected to mask the signs and symptoms of uterine rupture, particularly because the most common sign of rupture is fetal heart tracing abnormalities. Adequate pain relief achieved with either CSE or epidurals may even encourage more women to opt for VBAC. The decision to proceed with TOLAC should occur only after appropriate discussion of the risks and benefits has occurred between the patient and her obstetrician and as long as no other contraindications exist. The final decision should be left up to the patient. There is no reliable way to predict risk of uterine rupture, but it may be associated with classical and low vertical uterine scars, induction of labor, and increased number of prior cesarean deliveries and risk may be decreased by previous vaginal birth. Other aspects of VBAC versus repeat cesarean pertaining to the fetus to consider include respiratory function, mother-infant contact, and initiation of breastfeeding, which may be delayed in cesarean deliveries. There is very little research concerning the effects of CSEs and epidurals on women undergoing TOLAC.There have been multiple studies comparing CSE and epidurals on nulliparous and multiparous women, but none have been done specifically on patients undergoing TOLAC. According to the American Society of Anesthesiologists (ASA) practice guidelines for obstetric anesthesia "nonrandomized comparative studies suggest that epidural analgesia may be used in a trial of labor for previous cesarean delivery patients without adversely affecting the incidence of vaginal delivery. Randomized comparison of epidural versus other anesthetic techniques were not found." They agree that neuraxial techniques improve the likelihood of vaginal delivery for patients attempting VBAC and suggest neuraxial catheter be placed in event of operative delivery. Because no study to date has compared CSEs and epidurals and their effects on the success of VBAC, this study aims to further investigate this arena.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Complications; Cesarean Section, Pregnancy
Keywords
trial of labor after cesarean, vaginal birth after cesarean, epidural vs combined spinal epidural

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural anesthesia
Arm Type
Experimental
Arm Description
Trial of labor after cesarean with an epidural for anesthesia: Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
Arm Title
Combined spinal and epidural anesthesia
Arm Type
Experimental
Arm Description
Trial of labor after cesarean with a combined spinal and epidural (CSE) for anesthesia: the epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
Intervention Type
Drug
Intervention Name(s)
Epidural anesthesia
Intervention Description
An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work. Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered.
Intervention Type
Drug
Intervention Name(s)
Combined spinal and epidural anesthesia
Intervention Description
A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes. The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr.
Primary Outcome Measure Information:
Title
Number of Participants With Vaginal Birth After Cesarean (VBAC)
Time Frame
at the time of delivery
Secondary Outcome Measure Information:
Title
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Description
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Time Frame
baseline
Title
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Description
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Time Frame
15 minutes after regional anesthesia
Title
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Description
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Time Frame
30 minutes after regional anesthesia
Title
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Description
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Time Frame
60 minutes after regional anesthesia
Title
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Description
Pain score was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of pain. Pain scores less than 3 are considered to indicate successful analgesia.
Time Frame
24 hours after regional anesthesia
Title
Childbirth Experience as Assessed by a Visual Analogue Scale (VAS)
Description
Childbirth experience was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a better childbirth experience.
Time Frame
24 hours after regional anesthesia
Title
Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS)
Description
Maternal Satisfaction was assessed by a visual analogue scale (VAS) with a scale of 1 to 10, with higher scores indicating a higher level of satisfaction.
Time Frame
24 hours after regional anesthesia
Title
Neonatal Outcome as Assessed by (APGAR) Score
Description
Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Time Frame
1 minute after birth
Title
Neonatal Outcome as Assessed by (APGAR) Score
Description
Apgar score is a method to quickly summarize the health of newborn children. The Apgar scale is determined by evaluating the newborn baby on five simple criteria [Appearance (skin color), Pulse (heart rate), Grimace (reflex irritability), Activity (muscle tone), and Respiration]. Each crtieria is rated on a scale from 0 to 2, then summing up the five values thus obtained. The resulting Apgar total score ranges from zero to 10. Scores of 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low.
Time Frame
5 minutes after birth
Title
Time From Regional Anesthesia to Delivery
Time Frame
from regional anesthesia to delivery (about 86 - 1205 minutes)
Title
Time From Second Stage of Labor to Delivery
Description
The second stage of delivery begins after the cervix has dilated to 10 centimeters (cm).
Time Frame
from the second stage of labor to delivery (about 6 to 174 minutes)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all patients meeting ACOG guidelines for TOLAC at least one previous elective cesarean delivery <40 weeks gestational age (GA) vertex singleton pregnancy with use of continuous fetal monitoring Exclusion Criteria: Patient refusal of regional anesthetic or with contraindication for regional anesthesia BMI >40 associated comorbidities such as gestational diabetes, preeclampsia, abnormal placentation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Opal Raj, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon B. Johnson Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)

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