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NCT Number: NCT06471790

Inertial Sensors for Obstetrical Walking Epidural Tracking

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location status: Recruiting

Location contact

Mikhail DZIADZKO, MD

CONTACT

Mikhail DZIADZKO, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mikhail DZIADZKO, MD

CONTACT

[email protected]

04.26.10.93.25 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Movement Observation and Tracking In Obstetrics - Epidural and Ambulation Feasibility Study Using Inertial Sensors

Acronym: MOTION-EASE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Jan 20, 2026

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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