Inertial Sensors for Obstetrical Walking Epidural Tracking
NCT ID: NCT06471790
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-11-11
2026-07-12
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Mikhail PH DZIADZKO, MD
Role: PRINCIPAL_INVESTIGATOR
Anesthésie Réanimation Douleur
Locations
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Hôpital de la Croix Rousse
Lyon, , France
Countries
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Central Contacts
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Facility Contacts
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Mikhail DZIADZKO, MD
Role: primary
Other Identifiers
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2024-A00279-38
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL24_0097
Identifier Type: -
Identifier Source: org_study_id