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Completed

NCT Number: NCT03710382

The WE Pilot Study: Walking Epidurals

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking epidural

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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).

  2. 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

    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.

  3. Satisfaction of the labor ward nurses towards the walking epidural protocol

    Time frame: Following delivery, on Day 1

    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.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2018
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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