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临床试验/NCT04056793
NCT04056793已完成不适用

A Qualitative Study to Assess the Feasibility and Acceptability of an Optimized Birthing Position

Centre Hospitalier Universitaire Vaudois1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Acceptability of the optimized birthing position assessed by calculating the average score obtained through the VAS

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •Informed consent as documented by signature
  • •Parturient in situation of mechanical dystocia (non engagement at full dilation)

排除标准

  • •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

研究组 & 干预措施

Parturients in situation of dystocia

Experimental

Positioning of the parturients in an optimized birthing position

干预措施: Optimized birthing position (Other)

结局指标

主要结局

Acceptability of the optimized birthing position assessed by calculating the average score obtained through the VAS

时间窗: 20 minutes

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

次要结局

  • 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)
  • Height and head circumference of the foetus measured in centimeters(20 minutes)
  • Number of refusals(20 minutes)
  • Number of risk factors of non-engagement of the foetus at full dilation(20 minutes)
  • Weight of the foetus measured in kilograms(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DAVID DESSEAUVE

Médecin cadre - MD, PhD, PD-MER

Centre Hospitalier Universitaire Vaudois

研究点 (1)

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