Acceptability Assessment of an Optimized Birthing Position
A Qualitative Study to Assess the Feasibility and Acceptability of an Optimized Birthing Position
1 other identifier
interventional
20
1 country
1
Brief Summary
This qualitative study evaluates the acceptability of positioning pregnant women in labour in an optimized position, which consists in the hyperflexion of the legs and the loss of the lumbar lordosis. Twenty patients in situation of dystocia will adopt the described position for a limited amount of time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 6, 2019
CompletedFirst Submitted
Initial submission to the registry
August 9, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFebruary 16, 2021
February 1, 2021
5 months
August 9, 2019
February 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acceptability of the optimized birthing position assessed by calculating the average score obtained through the VAS
The Visual Analogue Scale will allow to obtain a score from 0 to 10, 0 standing for complete dissatisfaction and 10 for complete satisfaction of the participants
20 minutes
Secondary Outcomes (6)
Number of refusals
20 minutes
Number of risk factors of non-engagement of the foetus at full dilation
20 minutes
Neonatal adaptation assessed by the Apgar score
20 minutes
Birth outcome assessed by the percentage of vaginal delivery, Caesarian Section, delivery hemorrhage and perineal tear
20 minutes
Weight of the foetus measured in kilograms
20 minutes
- +1 more secondary outcomes
Study Arms (1)
Parturients in situation of dystocia
EXPERIMENTALPositioning of the parturients in an optimized birthing position
Interventions
The parturients will be asked to adopt a supine position with a hyperflexion of the thighs and a flat back, and to maintain the position for a duration of twenty minutes.
Eligibility Criteria
You may qualify if:
- Informed consent as documented by signature
- Parturient in situation of mechanical dystocia (non engagement at full dilation)
You may not qualify if:
- Inability or medical contraindications to undergo the investigated intervention (e.g. orthopaedic injury or disease preventing the parturient from adopting the optimised position)
- Clinically significant concomitant diseases
- Incapacity of judgment
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, etc.
- Foetus cardiac rhythm disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pr David Baud - Médecin chef de service - MD, PHD
Centre Hospitalier Universitaire Vaudois
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Médecin cadre - MD, PhD, PD-MER
Study Record Dates
First Submitted
August 9, 2019
First Posted
August 14, 2019
Study Start
August 6, 2019
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
February 16, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share