Inertial Sensors for Obstetrical Walking Epidural Tracking

NCT06471790 | Recruiting

• 2 other identifiers: 69HCL24_00972024-A00279-38
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Freedom of movement and the ability to walk are crucial during the first stage of labor, potentially reducing labor duration, cesarean section risk, epidural analgesia use, and bladder catheterization. While the clinical effects of ambulation during labor remain controversial, there is a consensus on its positive impact on the birthing experience and satisfaction. Epidural analgesia remains the gold standard for pain control during labor, with a utilization rate of 82% in France. Recent advancements in obstetric analgesia have allowed for lower doses of analgesics, often administered via patient-controlled analgesia, which maintains the potential for ambulation during labor. However, only a small number of maternity units in France offer this technique. The main barriers include organizational issues such as unsuitable facilities, lack of wireless telemetry, and potential risks such as falls and hypotension. Significant changes in gait characteristics are observed throughout pregnancy, particularly during the third trimester, and are studied in laboratory settings using video capture and analysis. Gait during labor is influenced by pain, fetal progression, and anatomical changes in the pelvis. The presence of epidural analgesia, where local anesthetics likely affect neural transmission, may impact motor commands and sensory feedback, further altering gait characteristics. These biomechanical aspects of labor remain understudied. Wearable inertial sensors show promise in maternal health monitoring by providing real-time data for motion and gait studies. However, their application has not been described or validated during labor, particularly in walking conditions. Continuous dynamic study of gait in these conditions could enable non-invasive, non-intrusive monitoring of analgesia effectiveness, fall risk prediction, and labor progression analysis. The aim of this feasibility study is to validate the use of wearable inertial sensors to quantify movements and characterize gait during the first stage of labor, both with and without low-dose epidural analgesia.

Conditions

Pregnancy Related; Labor Complication; Epidural; Anesthesia, Headache

Keywords

PREGNANCY; LABOR; EPIDURAL ANALGESIA; WALKING EPIDURAL; MOVEMENTS; GAIT; INERTIAL SENSOR

Outcome Measures

Primary Outcomes (1)

• triaxial (x, y, z) velocity changes over time unit (dV/dt) = m/s2 (meter over square second)

  gait patterns derived from accelerometer data measuring acceleration in three axes (x, y, z)

  during walking starting from the demand of the parturient to have an epidural up to delivery

Study Arms (1)

Walking Epidural Analgesia for Labor

Pregnant women in labor who benefit from walking epidural analgesia technique will be monitored using inertial wearable sensors beginning from the first stage of labor and up to delivery.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

at-term (\>= 38 gestation weeks) women admitted to the maternity facility for labor and delivery and willing low dose epidural analgesia with walking option

You may qualify if:

• pregnancy \>= 38 gestation weeks
• no significant medical history (American Society of Anesthesiologists class ASA 1)
• receiving low-dose epidural analgesia with ambulation (in accordance with current service protocol)
• not opposed to the study

You may not qualify if:

• Refusal to participate in this study
• Non-French-speaking patient
• History of osteoarticular pathology likely to change gate (severe scoliosis, spinal surgery, congenital hip deformity, pelvic fracture, ligament or knee joint pathology)
• adults under legal protection
• multiple pregnancy
• need for continuous intravenous infusion with infusion stand during ambulation

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, France

RECRUITING

MeSH Terms

Conditions

Headache; Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mikhail PH DZIADZKO, MD

  Anesthésie Réanimation Douleur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mikhail DZIADZKO, MD

CONTACT

04.26.10.93.25; mikhail.dziadzko@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 24, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): July 12, 2026
• Study Completion (Estimated): July 12, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)