Clinical trial NCT03710382: The WE Pilot Study: Walking Epidurals
Official title: The WE Pilot Study: Walking Epidurals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective pilot study with single group assignment
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Gestational age of 37 weeks or more
* Spontaneous ou induced labor
* Singleton fetus in the vertex presentation
* Agreement from obstetrician

Exclusion Criteria:

* American Society of Anesthesiologists' classification of 3 or more
* Contraindication to epidural anesthesia
* Complicated or high-risk pregnancy or delivery
* Comorbidities preventing safe ambulation

Primary outcomes:
measure: Adherence of the participants to an established time of ambulation during the first stage of labor (at least 15 minutes per hour)
timeFrame: From the installation of the epidural catheter until complete cervical dilation, on Day 1
Secondary outcomes:
measure: Safety of walking epidurals defined as the absence of motor block and orthostatic hypotension
timeFrame: Every hour, from the installation of the epidural catheter until complete cervical dilation, on Day 1
measure: Quality of pain relief using a verbal numeric pain scale
timeFrame: Every hour, from the installation of the epidural catheter until delivery, on Day 1
measure: Satisfaction of the labor ward nurses towards the walking epidural protocol
timeFrame: Following delivery, on Day 1
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Louise Roy, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: