German Clinical Trials Register

Acronym/abbreviation of the study

GebStart-Study

URL of the study

https://www.zhaw.ch/de/gesundheit/forschung/hebammen/projekte/entwicklung-und-validierung-eines-tools-fuer-die-beratung-von-erstgebaerenden-in-der-latenzphase-gebstart-studie/

Brief summary in lay language

BACKGROUND: Women giving birth to their first child often struggle to cope with the contractions and discomfort of the latent phase, meaning the symptoms of onset of labour for childbirth. If hospital admission occurs before the birth progresses, this is associated with increased rates of interventions and caesarean sections. However, staying at home in labour can cause anxiety. Care in the latent phase is often unsatisfactory for the woman giving birth and a challenge for health professionals. CONTENT AND AIM OF THE RESEARCH PROJECT: There is an urgent need to develop an instrument that allows for an evidence-based and individual assessment of the physical and emotional state of women in the latent phase. This instrument can be used to determine the care needs of women and advise the decision for or against hospital admission. Therefore, this study will develop and validate a standardised questionnaire for advising primiparous women in the latent phase. In addition to the quality criteria of the questionnaire, the satisfaction of women, midwives and doctors with the use of the instrument will be investigated. The data collection will be carried out in cooperation with six Swiss hospitals. SCIENTIFIC AND SOCIAL CONTEXT OF THE RESEARCH PROJECT: The standardised questionnaire can be used by health professionals during the initial telephone or face-to-face contact with first-time mothers. The structured advising has the potential to shorten hospital stays, increase spontaneous birth rates and reduce intervention rates. The study also aims to make an important contribution to the scientific discussion for optimising care in the latent phase and to provide a basis for further research.

Brief summary in scientific language

BACKGROUND: Pregnant women experience early labour as the first phase of labour with different physical and emotional symptoms. Early admission to hospital has been found to be associated with increased intervention and caesarean section rates. However, primiparous women often contact the hospital before labour progresses because they might have difficulties coping with labour pain at home. Previous studies investigating early labour care have not resulted in increased spontaneous birth rates and have not provided evidence regarding the appropriate care during early labour. An evidence-based instrument assessing the physical and emotional state within the early labour process and the wellbeing of woman and thereby, their need for support, is required to inform the decision for or against hospital admission. OBJECTIVES: The study aims to develop and validate a tool for the structured advice for primiparous women during early labour. The specific objectives are: (a) The evidence-based development of the tool, (b) The assessment of validity (content and construct validity) and reliability (internal consistency) of this instrument, (c) The evaluation of women’s, midwives’ and doctors’ satisfaction with the use of the tool, and (d) The investigation of the potential of the use of the tool to improve perinatal outcomes. METHODOLOGICAL APPROACH: The study will last three years and contains the following steps: (1) Generation of an item pool with 99 items based on a scoping review (symptoms of onset of labour, care and support needs) and focus group discussions with women (experiences) as well as determination of formats of measurements, (2) Assessment of content and face validity by an expert panel and item reduction to 32 items, (3) Multicentre data collection in six sites in the Zurich region as well as Central and Northwest Switzerland, with the application of the preliminary instrument and the validation items with a target sample size of n=400 women, and (4) Exploratory factor analysis for item reduction, designing the final version of the instrument with 15-20 items and assessing quality criteria of the instrument, satisfaction with the use of the instrument and perinatal outcomes. RELEVANCE OF THE PROJECT: The development and validation of a tool to assess the physical and emotional state and wellbeing and thereby, the need of support will provide an instrument to advise primiparous women during early labour. It can be applied by midwives and doctors for the initial telephone or face to face contact. The use of the instrument is of great interest because it has the potential to shorten hospital stays, increase spontaneous birth rates and decrease intervention rates and thereby, lower costs. Additionally, this study will make an important contribution to the scientific discussion for optimising early labour care and provide a basis for further research.