PETRA:Threatened preterm labour - risk and care management v.1
Threatened preterm labour: a prospective cohort study of a clinical risk assessment tool and a qualitative exploration of women's experiences of risk assessment and management.
King's College London
Duration of Study in the UK
2 years, 7 months, 31 days
While preterm birth remains a major cause of infant mortality and morbidity, some interventions, e.g. steroids to improve the baby's lung function, and hospital admission, are known to reduce associated risks. Although these interventions are relatively safe, they still carry risk of side effects and incur cost, both for the woman, and the NHS. It is important these interventions are offered in a timely manner, but labour is unpredictable and difficult to diagnose accurately in the earlier stages. The majority of women with symptoms of threatened preterm labour (TPTL) will not deliver early, but many are treated "just in case", because the consequences of not treating could be devastating.
This study aims to improve the management and experience of women with TPTL by ensuring appropriate care is offered to those most at risk while reducing unnecessary intervention. We plan to achieve this by: 1) improving risk assessment through the development of a complex risk assessment tool and 2) establishing the factors that are important to women making decisions on whether to accept or decline interventions.
To address the first objective, we will carry out study of 1181 women with symptoms of TPTL. Relevant data will be collected and used to develop a risk assessment tool that calculates an individual risk score by combining risk factors with fetal fibronectin test results and cervical length measurements. In order to achieve the second objective, some of these women will be asked to participate in a qualitative study consisting of one-to-one, semi-structured interviews.
The study, funded as part of an NIHR Clinical Academic Training Fellowship, will recruit participants at St Thomas’ Hospital, London and other collaborating NHS sites over 32 months.
London - South East Research Ethics Committee
Date of REC Opinion
26 Nov 2014