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Welcome to the QUIDS Study

Quantitative Fibronectin to help Decision making in women with symptoms of Preterm Labour

Summary
The clinical diagnosis of preterm labour that leads to delivery is notoriously challenging. Up to 80% of women who have signs and symptoms of preterm labour remain pregnant after 7 days. This means that many women unnecessarily receive therapies aimed at preventing complications in preterm babies, to ensure benefit for the few babies that are actually born preterm. Possible treatments include steroids given to the mother to help mature preterm babies’ lungs; magnesium sulphate to help prevent brain damage in children born preterm; and transfer to a hospital so delivery will occur at a hospital with appropriate neonatal care facilities. In addition, treatments called tocolytics can be given to try to delay delivery until steroids are effective (48 hours) and to allow transfer to a different hospital, but there is little evidence that they improve outcomes for babies.

A test called quantitative fetal Fibronectin (qfFN) may help improve diagnosis of preterm labour. The test involves the measurement of fFN in a swab taken at speculum examination (like a smear test), which is part of the assessment of a woman presenting with signs and symptoms of preterm labour. The amount of fFN present in the sample can be measured in an analyser that provides results in less than 10 minutes. The lower the concentration of fFN in the sample, the less likely preterm delivery is to occur. Currently, the fFN test which is part of standard care, provides a positive or negative result. The ability to measure the absolute amount of fibronectin is new and has the potential to more accurately rule out preterm labour.

Quids
The main aim of this research is to see if qfFN can accurately rule out spontaneous preterm delivery within 7 days of testing. We will use our findings to develop decision support tool, to help women and clinicians assess how likely preterm delivery is, and decide whether to start treatment or not.

We plan to recruit 1600 women who will be eligible to have the fFN test. We anticipate that recruitment will last 12 months and around 15 sites will be involved in the UK.

General Data Protection Regulation (GDPR)
Participant Information

University of Edinburgh and NHS Lothian are the co-sponsors for this study based in the United Kingdom/ Scotland. We will use information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The co-sponsors will keep identifiable information about you until the study has finished. Consent forms (which contain your name) are filed for a minimum of 15 years in secure storage.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

You can find out more about how we use your information by clicking on the following links : [QUIDS QUIDS2/or by contacting below].

University of Edinburgh NHS Lothian
Data Protection Officer Data Protection Officer
Governance and Strategic Planning NHS Lothian
University of Edinburgh Waverley Gate
Old College 2-4 Waterloo Place
Edinburgh Edinburgh
EH8 9YL EH1 3EG
Tel: 0131 651 4114 Tel: 0131 465 5444
dpo@ed.ac.uk Lothian.DPO@nhs.net