Inertial Sensors for Obstetrical Walking Epidural Tracking

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

70 Participants
are grouped into 1 trial group
Group A: Walking Epidural Analgesia for Labor

Trial outcomes

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)

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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