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Inertial Sensors for Obstetrical Walking Epidural Tracking

Study acronym: MOTION-EASE
StatusRecruiting
PhaseNot specified
Started2024-11-11
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 12, 2026 → Jul 12, 2027
See other at-risk trials from Hospices Civils de Lyon

Amendment history

2026-09-04
critical
Study Status, Study Design v3
Enrollment increased: 30 → 70 participants
Primary completion pushed: 2026-07-12 → 2027-07-12
Completion pushed: 2026-07-12 → 2027-07-12
2026-01-16
minor
Study Status v2
Re-verified, no change to tracked fields
2024-11-25
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-04-02→2026-07-12
Completion date2026-04-02→2026-07-12
Start dateestimated 2024-07-01→confirmed 2024-11-11
Study sitesdetails revised at 1 of 1 site
2024-06-18
minor
Original filing
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.
Trial Details
NCT Number NCT06471790
Lead Sponsor Hospices Civils de Lyon
Conditions Pregnancy Related, Epidural; Anesthesia, Headache, Labor Complication
Enrollment 70 participants
Start Date 2024-11-11
Primary Completion 2027-07-12 (estimated)
Study Completion 2027-07-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-10