Sarah J Stock
A prognostic model, including quantitative fetal fibronectin, to predict preterm labour: the QUIDS meta-analysis and prospective cohort study
Stock, Sarah J; Horne, Margaret; Bruijn, Merel; White, Helen; Heggie, Robert; Wotherspoon, Lisa; Boyd, Kathleen; Aucott, Lorna; Morris, Rachel K; Dorling, Jon; Jackson, Lesley; Chandiramani, Manju; David, Anna; Khalil, Asma; Shennan, Andrew; Baaren, Gert-Jan van; Hodgetts-Morton, Victoria; Lavender, Tina; Schuit, Ewoud; Harper-Clarke, Susan; Mol, Ben; Riley, Richard D; Norman, Jane; Norrie, John
Authors
Margaret Horne
Merel Bruijn
Helen White
Robert Heggie
Lisa Wotherspoon
Kathleen Boyd
Lorna Aucott
Rachel K Morris
Jon Dorling
Lesley Jackson
Manju Chandiramani
Anna David
Asma Khalil
Andrew Shennan
Gert-Jan van Baaren
Victoria Hodgetts-Morton
Tina Lavender
Ewoud Schuit
Susan Harper-Clarke
Ben Mol
Richard D Riley
Jane Norman
John Norrie
Abstract
BACKGROUND: The diagnosis of preterm labour is challenging. False-positive diagnoses are common and result in unnecessary, potentially harmful treatments (e.g. tocolytics, antenatal corticosteroids and magnesium sulphate) and costly hospital admissions. Measurement of fetal fibronectin in vaginal fluid is a biochemical test that can indicate impending preterm birth. OBJECTIVES: To develop an externally validated prognostic model using quantitative fetal fibronectin concentration, in combination with clinical risk factors, for the prediction of spontaneous preterm birth and to assess its cost-effectiveness. DESIGN: The study comprised (1) a qualitative study to establish the decisional needs of pregnant women and their caregivers, (2) an individual participant data meta-analysis of existing studies to develop a prognostic model for spontaneous preterm birth within 7 days in women with symptoms of preterm labour based on quantitative fetal fibronectin and clinical risk factors, (3) external validation of the prognostic model in a prospective cohort study across 26 UK centres, (4) a model-based economic evaluation comparing the prognostic model with qualitative fetal fibronectin, and quantitative fetal fibronectin with cervical length measurement, in terms of cost per QALY gained and (5) a qualitative assessment of the acceptability of quantitative fetal fibronectin. DATA SOURCES/SETTING: The model was developed using data from five European prospective cohort studies of quantitative fetal fibronectin. The UK prospective cohort study was carried out across 26 UK centres. PARTICIPANTS: Pregnant women at 22+0-34+6 weeks' gestation with signs and symptoms of preterm labour. HEALTH TECHNOLOGY BEING ASSESSED: Quantitative fetal fibronectin. MAIN OUTCOME MEASURES: Spontaneous preterm birth within 7 days. RESULTS: The individual participant data meta-analysis included 1783 women and 139 events of spontaneous preterm birth within 7 days (event rate 7.8%). The prognostic model that was developed included quantitative fetal fibronectin, smoking, ethnicity, nulliparity and multiple pregnancy. The model was externally validated in a cohort of 2837 women, with 83 events of spontaneous preterm birth within 7 days (event rate 2.93%), an area under the curve of 0.89 (95% confidence interval 0.84 to 0.93), a calibration slope of 1.22 and a Nagelkerke R 2 of 0.34. The economic analysis found that the prognostic model was cost-effective compared with using qualitative fetal fibronectin at a threshold for hospital admission and treatment of =?2% risk of preterm birth within 7 days. LIMITATIONS: The outcome proportion (spontaneous preterm birth within 7 days of test) was 2.9% in the validation study. This is in line with other studies, but having slightly fewer than 100 events is a limitation in model validation. CONCLUSIONS: A prognostic model that included quantitative fetal fibronectin and clinical risk factors showed excellent performance in the prediction of spontaneous preterm birth within 7 days of test, was cost-effective and can be used to inform a decision support tool to help guide management decisions for women with threatened preterm labour. FUTURE WORK: The prognostic model will be embedded in electronic maternity records and a mobile telephone application, enabling ongoing data collection for further refinement and validation of the model. STUDY REGISTRATION: This study is registered as PROSPERO CRD42015027590 and Current Controlled Trials ISRCTN41598423. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 52. See the NIHR Journals Library website for further project information.
Journal Article Type | Article |
---|---|
Acceptance Date | Sep 25, 2021 |
Online Publication Date | Aug 25, 2023 |
Publication Date | Sep 25, 2021 |
Publicly Available Date | May 30, 2023 |
Journal | Health Technology Assessment |
Print ISSN | 1366-5278 |
Publisher | NIHR Journals Library |
Volume | 25 |
Issue | 52 |
Pages | 1-168 |
DOI | https://doi.org/10.3310/hta25520 |
Keywords | FETAL FIBRONECTIN; INDIVIDUAL PARTICIPANT DATA LEVEL META-ANALYSIS; NEONATAL; PARTURITION; PREGNANCY; PRETERM LABOUR; PROGNOSTIC MODEL. |
Publisher URL | https://doi.org/10.3310/hta25520 |
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