Labor PainPhase 4NCT02105558
Outcomes of Neuraxial Anesthetic Technique on the Trial of Labor After Cesarean (TOLAC)
A Phase 4 study testing Epidural anesthesia and Combined spinal and epidural anesthesia in people with Labor Pain and Complications; Cesarean Section, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on the success of Trial of Labor After Cesarean (TOLAC). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Complications; Cesarean Section, Pregnancy
- What is being tested?
- Epidural anesthesia and Combined spinal and epidural anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 13 Apr 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Patient refusal of regional anesthetic or with contraindication for regional anesthesia
- BMI >40
- associated comorbidities such as gestational diabetes, preeclampsia, abnormal placentation
Trial locations and contacts
1 site in 1 country.
About this study
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
To compare the effects of epidural versus combined spinal and epidural (CSE) anesthesia on the success of Trial of Labor After Cesarean (TOLAC).
Read the 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.
- Conditions
- Labor Pain, Complications; Cesarean Section, Pregnancy
- Being tested
- Epidural anesthesia, Combined spinal and epidural anesthesia
- Keywords
- trial of labor after cesarean, vaginal birth after cesarean, epidural vs combined spinal epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaDrug
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.
Combined spinal and epidural anesthesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Epidural anesthesia | Experimental | 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. Receives: Drug: Epidural anesthesia |
| Combined spinal and epidural anesthesia | Experimental | 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. Receives: Drug: Combined spinal and epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Vaginal Birth After Cesarean (VBAC)
Measured: at the time of delivery
Secondary outcomes (11)
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.
Measured: baseline
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.
Measured: 15 minutes after regional anesthesia
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.
Measured: 30 minutes after regional anesthesia
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.
Measured: 60 minutes after regional anesthesia
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.
Measured: 24 hours after regional anesthesia
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.
Measured: 24 hours after regional anesthesia
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.
Measured: 24 hours after regional anesthesia
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.
Measured: 1 minute after birth
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.
Measured: 5 minutes after birth
Time From Regional Anesthesia to Delivery
Measured: from regional anesthesia to delivery (about 86 - 1205 minutes)
Time From Second Stage of Labor to Delivery
The second stage of delivery begins after the cervix has dilated to 10 centimeters (cm).
Measured: from the second stage of labor to delivery (about 6 to 174 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion13 Apr 2017
- Study completion13 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Lynne Erian, The University of Texas Health Science Center, Houston
- Investigators
- Opal Raj, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105558
- Sponsor's protocol ID
- HSC-MS-14-0023
- Status last verified
- Jun 2018
- First submitted
- 2 Apr 2014
- Last updated
- 19 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02105558
- Acronym / sponsor ID
- HSC-MS-14-0023
- Conditions
- Labor Pain, Complications; Cesarean Section, Pregnancy
- Keywords
- trial of labor after cesarean, vaginal birth after cesarean, epidural vs combined spinal epidural
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 13 Apr 2017 (actual)
- Study completion
- 13 Apr 2017 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Posted 19 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural anesthesia | Experimental | Drug: Epidural anesthesiaTrial 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. |
| Combined spinal and epidural anesthesia | Experimental | Drug: Combined spinal and epidural anesthesiaTrial 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patient refusal of regional anesthetic or with contraindication for regional anesthesia
- BMI >40
- associated comorbidities such as gestational diabetes, preeclampsia, abnormal placentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anesthesiaAn 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. | Drug | Epidural anesthesia |
| Combined spinal and epidural anesthesiaA 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. | Drug | Combined spinal and epidural anesthesia |
Primary outcome
Number of Participants With Vaginal Birth After Cesarean (VBAC)
Time frame: at the time of delivery
11 secondary outcomes
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Time frame: baseline
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Time frame: 15 minutes after regional anesthesia
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Time frame: 30 minutes after regional anesthesia
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Time frame: 60 minutes after regional anesthesia
Success of Analgesia as Indicated by Pain Score Assessed by Visual Analogue Scale (VAS)
Time frame: 24 hours after regional anesthesia
Childbirth Experience as Assessed by a Visual Analogue Scale (VAS)
Time frame: 24 hours after regional anesthesia
Maternal Satisfaction as Assessed by a Visual Analogue Scale (VAS)
Time frame: 24 hours after regional anesthesia
Neonatal Outcome as Assessed by (APGAR) Score
Time frame: 1 minute after birth
Neonatal Outcome as Assessed by (APGAR) Score
Time frame: 5 minutes after birth
Time From Regional Anesthesia to Delivery
Time frame: from regional anesthesia to delivery (about 86 - 1205 minutes)
Time From Second Stage of Labor to Delivery
Time frame: from the second stage of labor to delivery (about 6 to 174 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Opal Raj, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epidural anesthesia and Combined spinal and epidural anesthesia in people with Labor Pain and Complications; Cesarean Section, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Vaginal Birth After Cesarean (VBAC) (time frame: at the time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.