The WE Pilot Study: Walking Epidurals

NCT03710382 | Completed

• 1 other identifier: 18.213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Outcome Measures

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)

  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.

  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

  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

  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

  Following delivery, on Day 1

Study Arms (1)

Walking epidural

EXPERIMENTAL

Parturients will receive a lower concentration of bupivacaine in their epidural infusion and will be encouraged to walk during labor.

Other: Walking epidural

Interventions

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.

Walking epidural

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Louise Roy, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective pilot study with single group assignment

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 18, 2018
• Study Start: January 14, 2019
• Primary Completion: March 22, 2019
• Study Completion: March 22, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-01

Locations

CA (1)