{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T22:04:09Z","timestamp":1765836249221,"version":"3.48.0"},"reference-count":22,"publisher":"BMJ","issue":"4","funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2018,3,2]]},"published-print":{"date-parts":[[2018,4]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The aim of the QUIDS study is to develop a decision support tool for the management of women with symptoms and signs of preterm labour, based on a validated prognostic model using quantitative fetal fibronectin (fFN) concentration, in combination with clinical risk factors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      The study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts, USA) which quantifies fFN in a vaginal swab. In QUIDS part 2, we will perform a prospective cohort study in at least eight UK consultant-led maternity units, in women with symptoms of preterm labour at 22\n                      <jats:sup>+0<\/jats:sup>\n                      \u2009to 34\n                      <jats:sup>+6<\/jats:sup>\n                      weeks gestation to externally validate a prognostic model developed in QUIDS part 1. The effects of quantitative fFN on anxiety will be assessed, and acceptability of the test and prognostic model will be evaluated in a subgroup of women and clinicians (n=30). The sample size is 1600 women (with estimated 96\u2013192 events of preterm delivery within 7 days of testing). Clinicians will be informed of the qualitative fFN result (positive\/negative) but be blinded to quantitative fFN result. Research midwives will collect outcome data from the maternal and neonatal clinical records. The final validated prognostic model will be presented as a mobile or web-based application.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study is funded by the National Institute of Healthcare Research Health Technology Assessment (HTA 14\/32\/01). It has been approved by the West of Scotland Research Ethics Committee (16\/WS\/0068).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Version<\/jats:title>\n                    <jats:p>Protocol V.2, Date 1 November 2016.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"ISRCTN41598423\" ext-link-type=\"isrctn\">ISRCTN41598423<\/jats:ext-link>\n                      and CPMS: 31277.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-020795","type":"journal-article","created":{"date-parts":[[2019,3,27]],"date-time":"2019-03-27T13:13:30Z","timestamp":1553692410000},"page":"e020795","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study"],"prefix":"10.1136","volume":"8","clinical-trial-number":[{"clinical-trial-number":"isrctn41598423","registry":"10.18810\/isrctn"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4308-856X","authenticated-orcid":false,"given":"Sarah Jane","family":"Stock","sequence":"first","affiliation":[{"name":"Tommy\u2019s Centre for Maternal and Fetal Health, University of Edinburgh MRC Centre for Reproductive Health, Queen\u2019s Medical Research Institute, Edinburgh, UK"},{"name":"School of Women\u2019s and Infants\u2019 Health, 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