Labor PainNCT03710382
The WE Pilot Study: Walking Epidurals
A study testing Walking epidural in people with Labor Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The primary objective of the study is to assess the feasibility of a walking epidural protocol in our center. This study will provide a small data set for a larger prospective randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Walking epidural
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jan 2019to 22 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational age of 37 weeks or more
- Spontaneous ou induced labor
- Singleton fetus in the vertex presentation
- Agreement from obstetrician
Who cannot join
- American Society of Anesthesiologists' classification of 3 or more
- Contraindication to epidural anesthesia
- Complicated or high-risk pregnancy or delivery
- Comorbidities preventing safe ambulation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
The primary objective of the study is to assess the feasibility of a walking epidural protocol in our center. This study will provide a small data set for a larger prospective randomized controlled study.
Hypothesis: Walking a minimum of 15 minutes per hour will decrease the incidence of instrumental deliveries (forceps and vacuum) in women presenting in spontaneous or induced labor with neuraxial analgesia. Before testing this hypothesis in a randomized controlled study, the feasibility of this protocol needs to be assessed since allowing laboring women to ambulate while receiving neuraxial analgesia is not the standard-of-care at our institution.
Read the detailed description
Historically, women have labored in the upright position and it is only in the twentieth century that hospitalization and bedrest have become the standard of care during labor in most developed countries. This practice has been especially encouraged in patients laboring under neuraxial analgesia (epidural or combined spinal-epidural) because of the possibility of lower limb weakness associated with the use of local anesthetic agent.
Walking during labor has been associated with positive outcomes such as a reduction in the duration of labor, reduced incidence of assisted vaginal delivery and reduction of the rate of caesarean section in women in upright position compared to those bedridden, without being associated with negative effects on mothers' and babies' well-being. Proposed hypothesis to explain the reduction in duration of labor are an improved uterine contractility and an enhancement of pelvic diameter.
Impacts of ambulation during labor have also been studied in women with neuraxial analgesia but unfortunately, in these studies, a significant proportion of patients allowed to walk did not and, if they did, the time spent ambulating was extremely variable.
The reluctance to allow women to walk during neuraxial analgesia is mainly because of concerns of a possible motor block and of orthostatic hypotension. The combination of a low dose of local anesthetic agent and of an opioid for CSE has been shown to provide good analgesia while minimizing impairment of lower limbs' strength. Since a certain degree of leg weakness can occur even with low concentrations of local anesthetic agent, it is recommended to evaluate the presence of a motor block before allowing ambulation with neuraxial analgesia. For safe ambulation, meeting the following conditions is generally recommended: no lower limb weakness, ability to perform straight leg raise and complete hip flexion, performance of a partial knee bend, ability to step up on a stool with both legs, trial of walking witnessed by a member of the staff.
The other major concern related to ambulatory neuraxial analgesia is the risk of fall secondary to hypotension. Hypotension mainly occurs at initiation of neuraxial analgesia and is usually easily treated with small doses of phenylephrine and ephedrine, giving additional intravenous fluids and by placing the patient in the full lateral position. Interestingly, blood pressure seems to be more stable in the ambulant parturient than in the supine one probably due to the reduced incidence of aortocaval compression when standing. Since hypotension is mainly seen after initiation of neuraxial analgesia, most studies will allow at least 30 minutes after the bolus injection of the local anesthetic agent and blood pressure is verified in the erect position before ambulation is allowed.
In the absence of obstetrical contraindications, walking during labor with neuraxial analgesia is safe if a low concentration of local anesthetic agents is used and in the absence of motor block and orthostatic hypotension. In addition to these conditions, women ambulating must be accompanied by a companion at all times.
Considering the benefits of the upright position during labor in women without neuraxial analgesia, investigators presume that providing neuraxial analgesia that preserves motor function and allows the parturient to walk may be of benefit regarding the duration of labor, mode of delivery and maternal satisfaction. To this day, no study with a strict protocol for walking has addressed the effect of ambulation on obstetrical outcomes.
- Conditions
- Labor Pain
- Being tested
- Walking 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.
Walking epiduralOther
Parturients in spontaneous or induced labor will receive combined spinal-epidural analgesia (CSE) using an infusion of bupivacaine 0.0625% and fentanyl 2 mcg/mL and will be encouraged to walk a minimum of 15 minutes every hour during the first stage of labor.
| Study group | Role | What they receive |
|---|---|---|
| Walking epidural | Experimental | Parturients will receive a lower concentration of bupivacaine in their epidural infusion and will be encouraged to walk during labor. Receives: Other: Walking epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence of the participants to an established time of ambulation during the first stage of labor (at least 15 minutes per hour)
Patients will be encouraged to be mobile at least 15 minutes per hour during the first stage of labor. Time spent walking or on the exercise ball will be calculated every hour.
Measured: From the installation of the epidural catheter until complete cervical dilation, on Day 1
Secondary outcomes (3)
Safety of walking epidurals defined as the absence of motor block and orthostatic hypotension
Motor block will be assessed using the Modified Bromage Scale which is a 6-point scale where 1 means complete block (unable to move feet of knees) and 6 means able to perform partial knee bend. Hypotension will be defined as a 20% reduction in systolic blood pressure from Baseline (installation of the epidural catheter).
Measured: Every hour, from the installation of the epidural catheter until complete cervical dilation, on Day 1
Quality of pain relief using a verbal numeric pain scale
A verbal numeric pain (VNPS) scale will be used every hour to assess pain relief during the first stage of labor. On this scale, 0 means no pain and 10 means the most intense pain imaginable.
Measured: Every hour, from the installation of the epidural catheter until delivery, on Day 1
Satisfaction of the labor ward nurses towards the walking epidural protocol
Nurses will be asked to grade their satisfaction towards the walking epidural protocol using a satisfaction scale. This is a 0 to 10 scale, where 0 means completely dissatisfied and 10 means completely satisfied.
Measured: Following delivery, on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start14 Jan 2019
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective pilot study with single group assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louise Roy, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710382
- Sponsor's protocol ID
- 18.213
- Status last verified
- Jan 2019
- First submitted
- 12 Oct 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The WE Pilot Study: Walking Epidurals
- ClinicalTrials.gov ID
- NCT03710382
- Acronym / sponsor ID
- 18.213
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the feasibility of a walking epidural protocol in our center. This study will provide a small data set for a larger prospective randomized controlled study.
Hypothesis: Walking a minimum of 15 minutes per hour will decrease the incidence of instrumental deliveries (forceps and vacuum) in women presenting in spontaneous or induced labor with neuraxial analgesia. Before testing this hypothesis in a randomized controlled study, the feasibility of this protocol needs to be assessed since allowing laboring women to ambulate while receiving neuraxial analgesia is not the standard-of-care at our institution.
Detailed description
Historically, women have labored in the upright position and it is only in the twentieth century that hospitalization and bedrest have become the standard of care during labor in most developed countries. This practice has been especially encouraged in patients laboring under neuraxial analgesia (epidural or combined spinal-epidural) because of the possibility of lower limb weakness associated with the use of local anesthetic agent.
Walking during labor has been associated with positive outcomes such as a reduction in the duration of labor, reduced incidence of assisted vaginal delivery and reduction of the rate of caesarean section in women in upright position compared to those bedridden, without being associated with negative effects on mothers' and babies' well-being. Proposed hypothesis to explain the reduction in duration of labor are an improved uterine contractility and an enhancement of pelvic diameter.
Impacts of ambulation during labor have also been studied in women with neuraxial analgesia but unfortunately, in these studies, a significant proportion of patients allowed to walk did not and, if they did, the time spent ambulating was extremely variable.
The reluctance to allow women to walk during neuraxial analgesia is mainly because of concerns of a possible motor block and of orthostatic hypotension. The combination of a low dose of local anesthetic agent and of an opioid for CSE has been shown to provide good analgesia while minimizing impairment of lower limbs' strength. Since a certain degree of leg weakness can occur even with low concentrations of local anesthetic agent, it is recommended to evaluate the presence of a motor block before allowing ambulation with neuraxial analgesia. For safe ambulation, meeting the following conditions is generally recommended: no lower limb weakness, ability to perform straight leg raise and complete hip flexion, performance of a partial knee bend, ability to step up on a stool with both legs, trial of walking witnessed by a member of the staff.
The other major concern related to ambulatory neuraxial analgesia is the risk of fall secondary to hypotension. Hypotension mainly occurs at initiation of neuraxial analgesia and is usually easily treated with small doses of phenylephrine and ephedrine, giving additional intravenous fluids and by placing the patient in the full lateral position. Interestingly, blood pressure seems to be more stable in the ambulant parturient than in the supine one probably due to the reduced incidence of aortocaval compression when standing. Since hypotension is mainly seen after initiation of neuraxial analgesia, most studies will allow at least 30 minutes after the bolus injection of the local anesthetic agent and blood pressure is verified in the erect position before ambulation is allowed.
In the absence of obstetrical contraindications, walking during labor with neuraxial analgesia is safe if a low concentration of local anesthetic agents is used and in the absence of motor block and orthostatic hypotension. In addition to these conditions, women ambulating must be accompanied by a companion at all times.
Considering the benefits of the upright position during labor in women without neuraxial analgesia, investigators presume that providing neuraxial analgesia that preserves motor function and allows the parturient to walk may be of benefit regarding the duration of labor, mode of delivery and maternal satisfaction. To this day, no study with a strict protocol for walking has addressed the effect of ambulation on obstetrical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective pilot study with single group assignment
| Arm | Type | Receives |
|---|---|---|
| Walking epidural | Experimental | Other: Walking epiduralParturients will receive a lower concentration of bupivacaine in their epidural infusion and will be encouraged to walk during labor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gestational age of 37 weeks or more
- Spontaneous ou induced labor
- Singleton fetus in the vertex presentation
- Agreement from obstetrician
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists' classification of 3 or more
- Contraindication to epidural anesthesia
- Complicated or high-risk pregnancy or delivery
- Comorbidities preventing safe ambulation
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 |
|---|---|---|
| Walking epiduralParturients in spontaneous or induced labor will receive combined spinal-epidural analgesia (CSE) using an infusion of bupivacaine 0.0625% and fentanyl 2 mcg/mL and will be encouraged to walk a minimum of 15 minutes every hour during the first stage of labor. | Other | Walking epidural |
Primary outcome
Adherence of the participants to an established time of ambulation during the first stage of labor (at least 15 minutes per hour)
Time frame: From the installation of the epidural catheter until complete cervical dilation, on Day 1
Patients will be encouraged to be mobile at least 15 minutes per hour during the first stage of labor. Time spent walking or on the exercise ball will be calculated every hour.
3 secondary outcomes
Safety of walking epidurals defined as the absence of motor block and orthostatic hypotension
Time frame: Every hour, from the installation of the epidural catheter until complete cervical dilation, on Day 1
Quality of pain relief using a verbal numeric pain scale
Time frame: Every hour, from the installation of the epidural catheter until delivery, on Day 1
Satisfaction of the labor ward nurses towards the walking epidural protocol
Time frame: Following delivery, on Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- 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.
Louise Roy, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking epidural in people with Labor Pain, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 4 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 26 Mar 2019. 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 Canada. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence of the participants to an established time of ambulation during the first stage of labor (at least 15 minutes per hour) (time frame: From the installation of the epidural catheter until complete cervical dilation, on Day 1). 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 26 Mar 2019.