Complications; Cesarean Section, Labor Pain, Pregnancy
Conditions
Keywords
trial of labor after cesarean, vaginal birth after cesarean, epidural vs combined spinal epidural
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.
Interventions
DRUGEpidural anesthesia
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.
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Vaginal Birth After Cesarean (VBAC) | at the time of delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Childbirth Experience as Assessed by a Visual Analogue Scale (VAS) | 24 hours after regional anesthesia | 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) | 24 hours after regional anesthesia | 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. |
| Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | baseline | 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 From Regional Anesthesia to Delivery | from regional anesthesia to delivery (about 86 - 1205 minutes) | — |
| Time From Second Stage of Labor to Delivery | from the second stage of labor to delivery (about 6 to 174 minutes) | The second stage of delivery begins after the cervix has dilated to 10 centimeters (cm). |
| Neonatal Outcome as Assessed by (APGAR) Score | 1 minute after birth | 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. |
Countries
United States
Participant flow
Pre-assignment details
46 were enrolled, but only 43 started. Of the 3 who did not start: 1 gave birth before the block placement; 2 were disenrolled, but the reason was not recorded.
Participants by arm
| Arm | Count |
|---|---|
| Epidural Anesthesia 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. | 15 |
| Combined Spinal and Epidural (CSE) Anesthesia 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. | 28 |
| Total | 43 |
Baseline characteristics
| Characteristic | Total | Combined Spinal and Epidural (CSE) Anesthesia | Epidural Anesthesia |
|---|---|---|---|
| Actual fetal weight | 3346 grams STANDARD_DEVIATION 398 | 3292 grams STANDARD_DEVIATION 369 | 3453 grams STANDARD_DEVIATION 445 |
| Age, Continuous | 27.4 years STANDARD_DEVIATION 5.9 | 27.6 years STANDARD_DEVIATION 5.9 | 27.1 years STANDARD_DEVIATION 6.1 |
| Estimated fetal weight | 3341 grams STANDARD_DEVIATION 374 | 3264 grams STANDARD_DEVIATION 400 | 3484 grams STANDARD_DEVIATION 279 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants | 27 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Number of pregnancies | 3.1 number of pregnancies STANDARD_DEVIATION 1.3 | 3.0 number of pregnancies STANDARD_DEVIATION 0.9 | 3.3 number of pregnancies STANDARD_DEVIATION 1.6 |
| Reason for Previous Cesarean Arrest of labor | 1 Participants | 1 Participants | 0 Participants |
| Reason for Previous Cesarean Breech | 9 Participants | 4 Participants | 5 Participants |
| Reason for Previous Cesarean Chorioamnionitis | 1 Participants | 1 Participants | 0 Participants |
| Reason for Previous Cesarean Congenital fetal heart anomaly | 1 Participants | 1 Participants | 0 Participants |
| Reason for Previous Cesarean Failed induction | 1 Participants | 0 Participants | 1 Participants |
| Reason for Previous Cesarean Failure to progress | 8 Participants | 5 Participants | 3 Participants |
| Reason for Previous Cesarean Fetal bradycardia | 2 Participants | 2 Participants | 0 Participants |
| Reason for Previous Cesarean Fetal distress | 2 Participants | 1 Participants | 1 Participants |
| Reason for Previous Cesarean Gastrochisis | 1 Participants | 0 Participants | 1 Participants |
| Reason for Previous Cesarean Hydrocephalus | 1 Participants | 0 Participants | 1 Participants |
| Reason for Previous Cesarean Low amniotic fluid | 1 Participants | 1 Participants | 0 Participants |
| Reason for Previous Cesarean Macrosomia | 2 Participants | 2 Participants | 0 Participants |
| Reason for Previous Cesarean Macrosomia, breech | 1 Participants | 1 Participants | 0 Participants |
| Reason for Previous Cesarean Malpresentation | 1 Participants | 0 Participants | 1 Participants |
| Reason for Previous Cesarean Non-reassuring fetal heart tone | 4 Participants | 4 Participants | 0 Participants |
| Reason for Previous Cesarean Nuchal cord | 1 Participants | 1 Participants | 0 Participants |
| Reason for Previous Cesarean Oligohydramnios | 2 Participants | 2 Participants | 0 Participants |
| Reason for Previous Cesarean Placenta previa | 1 Participants | 1 Participants | 0 Participants |
| Reason for Previous Cesarean Pre-eclampsia | 1 Participants | 1 Participants | 0 Participants |
| Reason for Previous Cesarean Preterm premature rupture of the membranes (PPROM) | 1 Participants | 0 Participants | 1 Participants |
| Reason for Previous Cesarean Scoliosis, nuchal cord | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 43 Participants | 28 Participants | 15 Participants |
| Sex: Female, Male Female | 43 Participants | 28 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 28 |
| other Total, other adverse events | 5 / 15 | 4 / 28 |
| serious Total, serious adverse events | 0 / 15 | 0 / 28 |
Outcome results
Primary
Number of Participants With Vaginal Birth After Cesarean (VBAC)
Time frame: at the time of delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Epidural Anesthesia | Number of Participants With Vaginal Birth After Cesarean (VBAC) | 12 Participants |
| Combined Spinal and Epidural (CSE) Anesthesia | Number of Participants With Vaginal Birth After Cesarean (VBAC) | 22 Participants |
Secondary
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.
Time frame: 24 hours after regional anesthesia
Population: Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Childbirth Experience as Assessed by a Visual Analogue Scale (VAS) | 8.25 units on a scale | Standard Deviation 2.63 |
| Combined Spinal and Epidural (CSE) Anesthesia | Childbirth Experience as Assessed by a Visual Analogue Scale (VAS) | 9.25 units on a scale | Standard Deviation 1.21 |
Secondary
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.
Time frame: 24 hours after regional anesthesia
Population: Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS) | 8.42 units on a scale | Standard Deviation 2.28 |
| Combined Spinal and Epidural (CSE) Anesthesia | Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS) | 9.25 units on a scale | Standard Deviation 1.59 |
Secondary
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 frame: 1 minute after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Neonatal Outcome as Assessed by (APGAR) Score | 8.60 units on a scale | Standard Deviation 0.51 |
| Combined Spinal and Epidural (CSE) Anesthesia | Neonatal Outcome as Assessed by (APGAR) Score | 8.39 units on a scale | Standard Deviation 0.69 |
Secondary
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 frame: 5 minutes after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Neonatal Outcome as Assessed by (APGAR) Score | 8.93 units on a scale | Standard Deviation 0.26 |
| Combined Spinal and Epidural (CSE) Anesthesia | Neonatal Outcome as Assessed by (APGAR) Score | 9.04 units on a scale | Standard Deviation 0.19 |
Secondary
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.
Time frame: 24 hours after regional anesthesia
Population: Data for 3 participants in the epidural arm and 8 participants in the CSE arm were not recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 3.5 units on a scale | Standard Deviation 2.65 |
| Combined Spinal and Epidural (CSE) Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 2.53 units on a scale | Standard Deviation 2.58 |
Secondary
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.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 7.53 units on a scale | Standard Deviation 2.64 |
| Combined Spinal and Epidural (CSE) Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 8.20 units on a scale | Standard Deviation 1.89 |
Secondary
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.
Time frame: 15 minutes after regional anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 2.80 units on a scale | Standard Deviation 2.08 |
| Combined Spinal and Epidural (CSE) Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 2.13 units on a scale | Standard Deviation 2.3 |
Secondary
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.
Time frame: 30 minutes after regional anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 2.37 units on a scale | Standard Deviation 2.33 |
| Combined Spinal and Epidural (CSE) Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 1.77 units on a scale | Standard Deviation 2.05 |
Secondary
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.
Time frame: 60 minutes after regional anesthesia
Population: Data for 1 participant in the epidural arm were not recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 1.79 units on a scale | Standard Deviation 2.22 |
| Combined Spinal and Epidural (CSE) Anesthesia | Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS) | 1.63 units on a scale | Standard Deviation 2.15 |
Secondary
Time From Regional Anesthesia to Delivery
Time frame: from regional anesthesia to delivery (about 86 - 1205 minutes)
Population: For 2 participants in the CSE group, delivery time was not recorded and so the time from regional anesthesia to delivery could not be determined.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Time From Regional Anesthesia to Delivery | 415.7 minutes | Standard Deviation 208.2 |
| Combined Spinal and Epidural (CSE) Anesthesia | Time From Regional Anesthesia to Delivery | 454.5 minutes | Standard Deviation 279.1 |
Secondary
Time From Second Stage of Labor to Delivery
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)
Population: Because 2 in the epidural arm and 6 in the CSE arm never dilated to 10cms and were c-sectioned, it was not possible to obtain this value for these 8 participants. For 1 in the epidural arm and 1 in the CSE arm, delivery time was not recorded and so the time from the second stage of labor to delivery could not be determined for these 2 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Anesthesia | Time From Second Stage of Labor to Delivery | 71.25 minutes | Standard Deviation 49.93 |
| Combined Spinal and Epidural (CSE) Anesthesia | Time From Second Stage of Labor to Delivery | 42.57 minutes | Standard Deviation 44.82 |