Quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 1: Individual participant data meta-analysis and health economic analysis. Issue 4 (7th April 2018)

• Record Type: Journal Article
• Authors: Stock, Sarah J; Wotherspoon, Lisa M; Boyd, Kathleen A; Morris, Rachel K; Dorling, Jon; Jackson, Lesley; Chandiramani, Manju; David, Anna L; Khalil, Asma; Shennan, Andrew; Hodgetts Morton, Victoria; Lavender, Tina; Khan, Khalid; Harper-Clarke, Susan; Mol, Ben W; Riley, Richard D; Norrie, John; Norman, Jane E
• Is Part Of: BMJ open. Volume 8:Issue 4(2018)
• Publication Date: 2018-04-07
• Subjects: pregnancy -- preterm birth -- fetal fibronectin -- health economics -- individual patient data meta-analysis; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2017-020796
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: 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 (qfFN) concentration, in combination with clinical risk factors. Methods and analysis: The study will evaluate the Rapid fFN 10Q System (Hologic, Marlborough, Massachusetts) which quantifies fFN in a vaginal swab. In part 1 of the study, we will develop and internally validate a prognostic model using an individual participant data (IPD) meta-analysis of existing studies containing women with symptoms of preterm labour alongside fFN measurements and pregnancy outcome. An economic analysis will be undertaken to assess potential cost-effectiveness of the qfFN prognostic model. The primary endpoint will be the ability of the prognostic model to rule out spontaneous preterm birth within 7 days. Six eligible studies were identified by systematic review of the literature and five agreed to provide their IPD (n=5 studies, 1783 women and 139 events of preterm delivery within 7 days of testing). Ethics and dissemination: 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). PROSPERO registration number: CRD42015027590 . Version: Protocol version 2, date 1 November 2016.