scholarly journals A prognostic model, including quantitative fetal fibronectin, to predict preterm labour: the QUIDS meta-analysis and prospective cohort study

2021 ◽  
Vol 25 (52) ◽  
pp. 1-168
Author(s):  
Sarah J Stock ◽  
Margaret Horne ◽  
Merel Bruijn ◽  
Helen White ◽  
Robert Heggie ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Preterm Birth ◽  
Prospective Cohort ◽  
Prognostic Model ◽  
Preterm Labour ◽  
Meta Analysis ◽  
Health Technology ◽  
Spontaneous Preterm Birth ◽  
Fetal Fibronectin

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.

scholarly journals Development and validation of a risk prediction model of preterm birth for women with preterm labour symptoms (the QUIDS study): A prospective cohort study and individual participant data meta-analysis

PLoS Medicine ◽  
2021 ◽  
Vol 18 (7) ◽  
pp. e1003686
Author(s):  
Sarah J. Stock ◽  
Margaret Horne ◽  
Merel Bruijn ◽  
Helen White ◽  
Kathleen A. Boyd ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Prediction Model ◽  
Risk Prediction ◽  
Prospective Cohort ◽  
Preterm Labour ◽  
Meta Analysis ◽  
Multiple Pregnancy ◽  
Signs And Symptoms ◽  
Risk Prediction Model ◽  
Spontaneous Preterm Birth

Background Timely interventions in women presenting with preterm labour can substantially improve health outcomes for preterm babies. However, establishing such a diagnosis is very challenging, as signs and symptoms of preterm labour are common and can be nonspecific. We aimed to develop and externally validate a risk prediction model using concentration of vaginal fluid fetal fibronectin (quantitative fFN), in combination with clinical risk factors, for the prediction of spontaneous preterm birth and assessed its cost-effectiveness. Methods and findings Pregnant women included in the analyses were 22+0 to 34+6 weeks gestation with signs and symptoms of preterm labour. The primary outcome was spontaneous preterm birth within 7 days of quantitative fFN test. The risk prediction model was developed and internally validated in an individual participant data (IPD) meta-analysis of 5 European prospective cohort studies (2009 to 2016; 1,783 women; mean age 29.7 years; median BMI 24.8 kg/m2; 67.6% White; 11.7% smokers; 51.8% nulliparous; 10.4% with multiple pregnancy; 139 [7.8%] with spontaneous preterm birth within 7 days). The model was then externally validated in a prospective cohort study in 26 United Kingdom centres (2016 to 2018; 2,924 women; mean age 28.2 years; median BMI 25.4 kg/m2; 88.2% White; 21% smokers; 35.2% nulliparous; 3.5% with multiple pregnancy; 85 [2.9%] with spontaneous preterm birth within 7 days). The developed risk prediction model for spontaneous preterm birth within 7 days included quantitative fFN, current smoking, not White ethnicity, nulliparity, and multiple pregnancy. After internal validation, the optimism adjusted area under the curve was 0.89 (95% CI 0.86 to 0.92), and the optimism adjusted Nagelkerke R2 was 35% (95% CI 33% to 37%). On external validation in the prospective UK cohort population, the area under the curve was 0.89 (95% CI 0.84 to 0.94), and Nagelkerke R2 of 36% (95% CI: 34% to 38%). Recalibration of the model’s intercept was required to ensure overall calibration-in-the-large. A calibration curve suggested close agreement between predicted and observed risks in the range of predictions 0% to 10%, but some miscalibration (underprediction) at higher risks (slope 1.24 (95% CI 1.23 to 1.26)). Despite any miscalibration, the net benefit of the model was higher than “treat all” or “treat none” strategies for thresholds up to about 15% risk. The economic analysis found the prognostic model was cost effective, compared to using qualitative fFN, at a threshold for hospital admission and treatment of ≥2% risk of preterm birth within 7 days. Study limitations include the limited number of participants who are not White and levels of missing data for certain variables in the development dataset. Conclusions In this study, we found that a risk prediction model including vaginal fFN concentration and clinical risk factors showed promising performance in the prediction of spontaneous preterm birth within 7 days of test and has potential to inform management decisions for women with threatened preterm labour. Further evaluation of the risk prediction model in clinical practice is required to determine whether the risk prediction model improves clinical outcomes if used in practice. Trial registration The study was approved by the West of Scotland Research Ethics Committee (16/WS/0068). The study was registered with ISRCTN Registry (ISRCTN 41598423) and NIHR Portfolio (CPMS: 31277).

scholarly journals Study protocol: quantitative fibronectin to help decision-making in women with symptoms of preterm labour (QUIDS) part 2, UK Prospective Cohort Study

BMJ Open ◽  
2018 ◽  
Vol 8 (4) ◽  
pp. e020795
Author(s):  
Sarah Jane Stock ◽  
Lisa M Wotherspoon ◽  
Kathleen Anne Boyd ◽  
Rachel K Morris ◽  
Jon Dorling ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Prognostic Model ◽  
Preterm Labour ◽  
Outcome Data ◽  
Healthcare Research ◽  
Fetal Fibronectin ◽  
Support Tool ◽  
Clinical Records

IntroductionThe 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.Methods and analysisThe 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+0 to 34+6 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 96–192 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.Ethics and disseminationThe 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).VersionProtocol V.2, Date 1 November 2016.Trial registration numberISRCTN41598423 and CPMS: 31277.

scholarly journals Accelerated Fetal Growth in Early Pregnancy and Risk of Preterm Birth: A Prospective Cohort Study

2020 ◽  
Author(s):  
Evangelia Elenis ◽  
Anna-Karin Wikström ◽  
Marija Simic
Keyword(s):  
Cohort Study ◽  
Preterm Birth ◽  
Prospective Cohort Study ◽  
Fetal Growth ◽  
Early Pregnancy ◽  
Prospective Cohort ◽  
Late Gestation ◽  
Second Trimester ◽  
Spontaneous Preterm Birth ◽  
Increased Risk

Abstract Background: Preterm birth (occurring before 37 completed weeks of gestation) affects 15 million infants annually, 7.5% of which die due to related complications. The detection and early diagnosis are therefore paramount in order to prevent the development of prematurity and its consequences. So far, focus has been laid on the association between reduced intrauterine fetal growth during late gestation and prematurity. The aim of the current study was to investigate the association between accelerated fetal growth in early pregnancy and the risk of preterm birth. Methods: This prospective cohort study included 69 617 singleton pregnancies without congenital malformations and with available biometric measurements during the first and second trimester. Estimation of fetal growth was based on measurements of biparietal diameter (BPD) at first and second trimester scan. We investigated the association between accelerated fetal growth and preterm birth prior to 37 weeks of gestation. The outcome was further stratified into very preterm birth (before 32 weeks of gestation) or moderate preterm birth (between 32 and 37 weeks of gestation) and medically induced or spontaneous preterm birth and was further explored. Results: The odds of prematurity were increased among fetuses with accelerated BPD growth (> 90th centile) estimated between first and second ultrasound scan, even after adjustment for possible confounders (aOR 1.36; 95% CI 1.20-1.54). The findings remained significant what regards moderate preterm births but not earlier births. Regarding medically induced preterm birth, the odds were found to be elevated in the group of fetuses with accelerated growth in early pregnancy (aOR 1.34; 95% CI 1.11-1.63). On the contrary, fetuses with delayed fetal growth exhibited lower risk for both overall and spontaneous preterm birth.Conclusions: Fetuses with accelerated BPD growth in early pregnancy, detected by ultrasound examination during the second trimester, exhibited increased risk of being born preterm. The findings of the current study suggest that fetal growth in early pregnancy should be taken into account when assessing the likelihood for preterm birth.

Spontaneous Preterm Birth and Small for Gestational Age Infants in Women Who Stop Smoking Early in Pregnancy: Prospective Cohort Study

2010 ◽  
Vol 30 (2) ◽  
pp. 91-92
Author(s):  
L.M. McCowan ◽  
G.A. Dekker ◽  
E. Chan ◽  
A. Stewart ◽  
L.C. Chappell ◽  
...  
Keyword(s):  
Cohort Study ◽  
Preterm Birth ◽  
Prospective Cohort Study ◽  
Gestational Age ◽  
Small For Gestational Age ◽  
Prospective Cohort ◽  
Spontaneous Preterm Birth ◽  
Stop Smoking ◽  
In Pregnancy

α and β-defensins and bacterial vaginosis as preterm birth predictors. A systematic review and meta-analysis.

2020 ◽  
Vol 2020 (4) ◽  
pp. 1-13
Author(s):  
Mariel Castillo-López ◽  
Keyword(s):  
Preterm Birth ◽  
Early Identification ◽  
Meta Analysis ◽  
Cervical Length ◽  
Premature Delivery ◽  
Spontaneous Preterm Birth ◽  
Fetal Fibronectin ◽  
Potential Damage ◽  
Type Of Delivery ◽  
Children Under 5

Preterm birth is an entity with potential damage to the newborn and it is the leading cause of mortality in children under 5 years old. Even though research on this topic has been increasing in the last decade, it has not reflected in a reduction in the incidence of this problem. Nowadays, raised cervical-vaginal fetal fibronectin concentration and short cervical length are considered the only predictors of spontaneous preterm birth [1], and given the adverse and severe consequences of preterm birth, the early identification of women with a higher risk of presenting this type of delivery is crucial for pregnancy care. Several studies have tried to find new inflammation markers that may allow the early identification of pregnant women at high risk of premature delivery, because as on many diseases, inflammatory mediators play a role on the pathophysiology of this entity. This literature review aims to discuss recent findings regarding to the association between the innate immune response, specifically β-defensins with preterm birth.

scholarly journals Accelerated fetal growth in early pregnancy and risk of preterm birth: a prospective cohort study

2020 ◽  
Author(s):  
Evangelia Elenis ◽  
Anna-Karin Wikström ◽  
Marija Simic
Keyword(s):  
Cohort Study ◽  
Preterm Birth ◽  
Prospective Cohort Study ◽  
Fetal Growth ◽  
Early Pregnancy ◽  
Prospective Cohort ◽  
Preterm Births ◽  
Second Trimester ◽  
Spontaneous Preterm Birth ◽  
Very Preterm

Abstract Background: Preterm birth (occurring before 37 completed weeks of gestation) affects 15 million infants annually, 7.5% of which die due to related complications. The detection and early diagnosis are therefore paramount in order to prevent the development of prematurity and its consequences. So far, focus has been laid on the association between reduced intrauterine fetal growth during late gestation and prematurity. The aim of the current study was to investigate the association between accelerated fetal growth in early pregnancy and the risk of preterm birth. Methods: This prospective cohort study included 69 617 singleton pregnancies without congenital malformations and with available biometric measurements during the first and second trimester. Estimation of fetal growth was based on measurements of biparietal diameter (BPD) at first and second trimester scan. We investigated the association between accelerated fetal growth and preterm birth prior to 37 weeks of gestation. The outcome was further stratified into very preterm birth (before 32 weeks of gestation) or moderate preterm birth (between 32 and 37 weeks of gestation) and medically induced or spontaneous preterm birth and was further explored. Results: The odds of prematurity were increased among fetuses with accelerated BPD growth (> 90th centile) estimated between first and second ultrasound scan, even after adjustment for possible confounders (aOR 1.36; 95% CI 1.20-1.54). The findings remained significant what regards moderate preterm births but not very preterm births. Regarding medically induced preterm birth, the odds were found to be elevated in the group of fetuses with accelerated growth in early pregnancy (aOR 1.34; 95% CI 1.11-1.63). On the contrary, fetuses with delayed fetal growth exhibited lower odds for both overall and spontaneous preterm birth.Conclusions: Fetuses with accelerated BPD growth in early pregnancy, detected by ultrasound examination during the second trimester, exhibited increased odds of being born preterm. The findings of the current study suggest that fetal growth in early pregnancy should be taken into account when assessing the risk for preterm birth.

scholarly journals Risk of preterm birth associated with maternal gingival inflammation and oral hygiene behaviours in rural Nepal: a community-based, prospective cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e036515
Author(s):  
Daniel J Erchick ◽  
Subarna K Khatry ◽  
Nitin K Agrawal ◽  
Joanne Katz ◽  
Steven C LeClerq ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Preterm Birth ◽  
Oral Health ◽  
Oral Hygiene ◽  
Prospective Cohort ◽  
Gingival Inflammation ◽  
Community Based ◽  
Rural Nepal ◽  
In Pregnancy

ObjectivesObservational studies have identified associations between periodontitis and adverse pregnancy outcomes, but randomised controlled trials evaluating the efficacy of periodontal therapy have yielded inconsistent results. Few studies have explored relationships between gingival inflammation and these outcomes or been conducted in rural, low-income communities, where confounding risk factors differ from other settings.MethodsWe conducted a community-based, prospective cohort study with the aim of estimating associations between the extent of gingival inflammation in pregnant women and incidence of preterm birth in rural Nepal. Our primary exposure was gingival inflammation, defined as bleeding on probing (BOP) ≥10%, stratified by BOP <30% and BOP ≥30%. A secondary exposure, mild periodontitis, was defined as ≥2 interproximal sites with probing depth (PD) ≥4 mm (different teeth) or one site with PD ≥5 mm. Our primary outcome was preterm birth (<37 weeks gestation). We used Poisson regression to model this relationship, adjusting for potential confounders.ResultsOf 1394 participants, 554 (39.7%) had gingival inflammation, 54 (3.9%) mild periodontitis and 197 (14.1%) delivered preterm. In the adjusted regression model, increasing extent of gingival inflammation was associated with a non-significant increase in risk of preterm birth (BOP ≥30% vs no BOP: adjusted relative risk (aRR) 1.37, 95% CI: 0.81 to 2.32). A secondary analysis, stratifying participants by when in pregnancy their oral health status was assessed, showed an association between gingival inflammation and preterm birth among women examined in their first trimester (BOP ≥30% vs no BOP: aRR 2.57, 95% CI: 1.11 to 5.95), but not later in pregnancy (BOP ≥30% vs no BOP: aRR 1.05, 95% CI: 0.52 to 2.11).ConclusionsGingival inflammation in women examined early in pregnancy and poor oral hygiene behaviours were risk factors for preterm birth. Future studies should evaluate community-based oral health interventions that specifically target gingival inflammation, delivered early in or before pregnancy, on preterm birth.Trial registration numberNepal Oil Massage Study, NCT01177111.

Incidence and risk factors for recurrent spontaneous preterm birth: A retrospective cohort study in Japan

2015 ◽  
Vol 41 (11) ◽  
pp. 1708-1714 ◽  
Author(s):  
Michiko Yamashita ◽  
Shusaku Hayashi ◽  
Masayuki Endo ◽  
Kentaro Okuno ◽  
On Fukui ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Preterm Birth ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Spontaneous Preterm Birth
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