Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471790
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
Inertial Sensors for Obstetrical Walking Epidural Tracking
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Movement Observation and Tracking In Obstetrics - Epidural and Ambulation Feasibility Study Using Inertial Sensors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOTION-EASE
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00279-38 | OTHER | None | None |