Pregnant woman's experience of using the Labour Support Chair.

The Intervention; The Labour Support Chair Appliance for use in supporting a woman during the first stage of Labour. Patent No's: USA, US 9,901,504 B2. Europe, EP 3 182 948 B1, Australia No. 2015306079 and patent-pending in New Zealand. This is a first in human, acceptability, feasibility randomised controlled trial, with 40 participants. The Labour Support Chair is designed to be straddled or sat on backwards in comparison to a conventional chair. This positioning promotes in the woman a posture that biomechanically benefits the process of her labour. The seat portion is flat and horizontal, longer and wider than a conventional chair seat, to accommodate the woman's pregnant abdomen. Rising vertically from the seat, between the woman's legs, is a front support panel. This panel has a narrow waist at the base for self-adjustment of the spread of the woman’s knees, then broadens out, to rest her chest against. The top of the front support panel is folded away from the woman, forming a ledge upon which she can rest her arms and head. Below this ledge, at approx. 15 cm from the ground is a footplate with hinged flaps on which the woman can rest her feet out wide or centrally when wrapping her legs around the narrow waist of the front support panel. The hinged flaps can be folded up, out of the way if not required. The woman’s back is readily accessible for massage and the Labour Support Chair is waterproof so can be used in the shower. The Labour Support Chair will only be available for use by the women randomised to the intervention arm. During labour, all participants will be provided with a Pictogram Chart which has 17 line drawings of activities and positions that women use in labour. The participants are asked to tick the positions or activities that they used during their labour. Sitting straddled a chair is not one of the line drawings, as this closely resembles the intervention of the Labour Support Chair. The Pictogram Chart will benchmark the usual labour care for the trial. Approximately two weeks after giving birth, all participants will be sent a survey named the Labour Agentry Scale (LAS). The LAS is a validated tool that produces a quantitative analysis of the participant woman’s experience of personal power during her labour. The LAS has 10 short statements and the participant will grade her experience from ‘ almost always’ to rarely’ on a 7 point Likert scale. There are also four supplementary questions for the intervention arm and only one for the non-intervention arm to answer. The Study introduction and training of midwives will occur across all shift times. The actual Labour support Chair will be present for teaching and practice purposes. A CardioTocoGraph (CTG) monitor will be borrowed from the birth unit if available, to demonstrate and practise performing fetal monitoring whist the woman is using the Labour Support Chair. Discussions around how to incorporate required clinical observations and usual midwifery care into the midwives practise, for the woman in the intervention are will be held during training as well. The midwives caring for the women in labour will complete a Tracking Chart specific for participants in both arms of the trial. The midwife is asked to record three (3) clinical observations common to both arms of the trial. These are the fetal position determined by abdominal palpation on admission to the birth unit, during the active second stage and at birth observed from the restitution of the fetal head. No additional vaginal examination will be requested for the Trial. The intervention arm’s Tracking Chart will also have a table called the Labour Chair Usage Table. Training will incorporate how to complete this table. Demonstrations during the training of the midwives will also incorporate, how to verbally instruct the participant to confidently, sit on and alight from the chair. Along with massage techniques the partner can perform on the back of participant, manoeuvring the chair into the shower for the comfort of warm water, the use of inhalational analgesia whilst resting on the Labour Support Chair as well as cleaning and storage. Registered midwives who care for women in labour at the Trial Site, will be delivering the intervention. These registered midwives will have attended a Study Training Session and signed the Study Training Log. These midwives will also be responsible for ‘posting’ the Tracking Chart and the Pictogram chart through the slot of the locked Study Box, located in the Birth Unit for collection by the research student. The midwife will bring the Labour Support Chair into the birth room of the participants who are randomised into the intervention arm of the trial. Here the midwife will instruct the participant how to sit on and alight from the Labour Support Chair. The participants in the intervention arm are free to use the Labour Support Chair as much as they choose. The protocol states that for compliance to the trial, a participant randomised to the intervention arm, is required to sit straddling the Labour Support Chair for a minimum of 20 minutes, whilst she is in the active, first stage of labour. The active, first stage of labour is defined in the protocol as at least three (3) strong contractions in 10 minutes. Therefore the participant would experience at least six (6) strong contractions, whilst she is straddling the chair. The midwife caring for her will guide the participant in this compliance feature and document these observations in 10-minute blocks, on the Labour Chair Usage Table, contained on the Tracking Chart- Intervention Arm. The participant in the intervention arm is free to use the Labour Support Chair as much as she chooses, before and after the compliance point. The intervention will occur in the room in which the participants will labour and birth. The Labour Support Chair will only be brought into the room of the participants randomised to the intervention arm. When trial participants are admitted to the Birth Unit either, in spontaneous labour or for a scheduled induction of labour, they will know which arm of the trial they belong. As a back-up, a document named ‘Randomisation Outcomes’, will be in the Site Investigators File (SIF) for the midwives to check the randomisation outcomes of participants, while waiting for the participant to arrive. The midwife will be asked to fill out a Labour Chair Usage Tracking Chart by shading in boxes that represent 10 minutely intervals. It is from this document that trial intervention adherence and fidelity will be assessed. If the participant does not fulfil the 20-minute requirement, she will be placed in the intention to treat group for analysis. No strategies will be employed by the midwives to ensure women stay on the chair for 20 minutes – this is entirely the woman’s choice.