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Completed

NCT Number: NCT04056793

Acceptability Assessment of an Optimized Birthing Position

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optimized birthing position

Other

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.

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Number of refusals

    Time frame: 20 minutes

    Number of parturients who will refuse to participate to the study

  2. Number of risk factors of non-engagement of the foetus at full dilation

    Time frame: 20 minutes

    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

  3. Neonatal adaptation assessed by the Apgar score

    Time frame: 20 minutes

    The Apgar score will be evaluated at 1, 5 and 10 minutes

  4. Birth outcome assessed by the percentage of vaginal delivery, Caesarian Section, delivery hemorrhage and perineal tear

    Time frame: 20 minutes

  5. Weight of the foetus measured in kilograms

    Time frame: 20 minutes

  6. Height and head circumference of the foetus measured in centimeters

    Time frame: 20 minutes

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2019
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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