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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04056793
Other study ID # 2019-00872
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 6, 2019
Est. completion date January 1, 2020

Study information

Verified date February 2021
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Recent data brings out that the Caesarian Section rate in Switzerland is quite high, reaching 33.4 %. Though, the reasons to this increasing amount of CS are not fully known. Therefore, it is absolutely necessary to expand the existing knowledge in different fields, including the biomechanics of childbirth. Numerous CS are performed in response to an obstructed labour, especially when the foetus does not engage in the pelvis near full dilatation. In order to manage such situations, midwifes currently position parturients in pragmatic postures. Although not verified by data, this care management suggests that it is possible to impact the position of the bone segments at stake for vaginal birth including pelvis and lumbar spine and to promote the descent of the foetus through the pelvic inlet plane. In his PhD thesis about vaginal birth biomechanics, Desseauve et al investigated this area and found out that an optimized position similar to the squatting position (hyperflexion of the thighs and loss of the lumbar lordosis) could be close to the perfect delivery position in terms of ability for the foetus to go through the pelvic inlet plane. Although these findings are encouraging, it is yet to be confirmed in clinical practice, particularly when a dystocia occurs. Prior to doing that, it is though necessary to validate the optimized posture in terms of acceptability in a qualitative clinical study. In this study, fifteen to twenty parturients who respond to the inclusion criteria and whose foetus does not engage in the pelvis near full dilation will be asked to adopt the optimized position for a twenty minutes period. The investigator will then consign information reflecting the progress of the labour on a data sheet.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Informed consent as documented by signature - Parturient in situation of mechanical dystocia (non engagement at full dilation) Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Optimized birthing position
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.

Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of refusals Number of parturients who will refuse to participate to the study 20 minutes
Secondary Number of risk factors of non-engagement of the foetus at full dilation The risk factors are constituted of macrosomy, medical induction of labour, artificial rupture of membranes, hypokinesia (<5 uterine contractions/min), use of oxytocin and presence of a peridural anaesthesia 20 minutes
Secondary Neonatal adaptation assessed by the Apgar score The Apgar score will be evaluated at 1, 5 and 10 minutes 20 minutes
Secondary Birth outcome assessed by the percentage of vaginal delivery, Caesarian Section, delivery hemorrhage and perineal tear 20 minutes
Secondary Weight of the foetus measured in kilograms 20 minutes
Secondary Height and head circumference of the foetus measured in centimeters 20 minutes
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05468658 - The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health N/A