Background The combination of the qualitative fetal fibronectin test and cervical length measurement has a high negative predictive value for preterm birth within 7 days; however, positive prediction ...is poor. A new bedside quantitative fetal fibronectin test showed potential additional value over the conventional qualitative test, but there is limited evidence on the combination with cervical length measurement. Objective The purpose of this study was to compare quantitative fetal fibronectin and qualitative fetal fibronectin testing in the prediction of spontaneous preterm birth within 7 days in symptomatic women who undergo cervical length measurement. Study Design We performed a European multicenter cohort study in 10 perinatal centers in 5 countries. Women between 24 and 34 weeks of gestation with signs of active labor and intact membranes underwent quantitative fibronectin testing and cervical length measurement. We assessed the risk of preterm birth within 7 days in predefined strata based on fibronectin concentration and cervical length. Results Of 455 women who were included in the study, 48 women (11%) delivered within 7 days. A combination of cervical length and qualitative fibronectin resulted in the identification of 246 women who were at low risk: 164 women with a cervix between 15 and 30 mm and a negative fibronectin test (<50 ng/mL; preterm birth rate, 2%) and 82 women with a cervix at >30 mm (preterm birth rate, 2%). Use of quantitative fibronectin alone resulted in a predicted risk of preterm birth within 7 days that ranged from 2% in the group with the lowest fibronectin level (<10 ng/mL) to 38% in the group with the highest fibronectin level (>500 ng/mL), with similar accuracy as that of the combination of cervical length and qualitative fibronectin. Combining cervical length and quantitative fibronectin resulted in the identification of an additional 19 women at low risk (preterm birth rate, 5%), using a threshold of 10 ng/mL in women with a cervix at <15 mm, and 6 women at high risk (preterm birth rate, 33%) using a threshold of >500 ng/mL in women with a cervix at >30 mm. Conclusion In women with threatened preterm birth, quantitative fibronectin testing alone performs equal to the combination of cervical length and qualitative fibronectin. Possibly, the combination of quantitative fibronectin testing and cervical length increases this predictive capacity. Cost-effectiveness analysis and the availability of these tests in a local setting should determine the final choice.
Quantification of bilirubin in blood is essential for early diagnosis and timely treatment of neonatal hyperbilirubinemia. Handheld point-of-care (POC) devices may overcome the current issues with ...conventional laboratory-based bilirubin (LBB) quantification.
To systematically evaluate the reported diagnostic accuracy of POC devices compared with LBB quantification.
A systematic literature search was conducted in 6 electronic databases (Ovid MEDLINE, Embase, Web of Science Core Collection, Cochrane Central Register of Controlled Trials, CINAHL, and Google Scholar) up to December 5, 2022.
Studies were included in this systematic review and meta-analysis if they had a prospective cohort, retrospective cohort, or cross-sectional design and reported on the comparison between POC device(s) and LBB quantification in neonates aged 0 to 28 days. Point-of-care devices needed the following characteristics: portable, handheld, and able to provide a result within 30 minutes. This study was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline.
Data extraction was performed by 2 independent reviewers into a prespecified, customized form. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 tool. Meta-analysis was performed of multiple Bland-Altman studies using the Tipton and Shuster method for the main outcome.
The main outcome was mean difference and limits of agreement in bilirubin levels between POC device and LBB quantification. Secondary outcomes were (1) turnaround time (TAT), (2) blood volumes, and (3) percentage of failed quantifications.
Ten studies met the inclusion criteria (9 cross-sectional studies and 1 prospective cohort study), representing 3122 neonates. Three studies were considered to have a high risk of bias. The Bilistick was evaluated as the index test in 8 studies and the BiliSpec in 2. A total of 3122 paired measurements showed a pooled mean difference in total bilirubin levels of -14 μmol/L, with pooled 95% CBs of -106 to 78 μmol/L. For the Bilistick, the pooled mean difference was -17 μmol/L (95% CBs, -114 to 80 μmol/L). Point-of-care devices were faster in returning results compared with LBB quantification, whereas blood volume needed was less. The Bilistick was more likely to have a failed quantification compared with LBB.
Despite the advantages that handheld POC devices offer, these findings suggest that the imprecision for measurement of neonatal bilirubin needs improvement to tailor neonatal jaundice management.
Objective The objective of the study was to evaluate the cost-effectiveness of risk stratification with cervical length (CL) measurement and/or fetal fibronectin (fFN) tests in women with threatened ...preterm labor between 24 and 34 weeks' gestation. Study Design We performed a model-based cost-effectiveness analysis to evaluate 7 test-treatment strategies in women with threatened preterm labor from a health care system perspective. Estimates on disease prevalence, costs, and test accuracy were based on medical literature. Results We found that additional fFN testing in the case of a CL between 10 and 30 mm is cost saving without compromising neonatal health outcomes, compared with a treat-all strategy or single CL testing. Implementing this strategy could lead to an annual cost saving between €2.8 million and €14.4 million in The Netherlands, a country with about 180,000 deliveries annually. Conclusion In women with threatened preterm labor between 24 and 34 weeks of gestation, the most cost-effective test strategy uses a combination of CL and fFN testing.
IntroductionSevere neonatal hyperbilirubinaemia can place a neonate at risk for acute bilirubin encephalopathy and kernicterus spectrum disorder. Early diagnosis is essential to prevent these ...deleterious sequelae. Currently, screening by visual inspection followed by laboratory-based bilirubin (LBB) quantification is used to identify hyperbilirubinaemia in neonates cared for at home in the Netherlands. However, the reliability of visual inspection is limited. We aim to evaluate the effectiveness of universal transcutaneous bilirubin (TcB) screening as compared with visual inspection to: (1) increase the detection of hyperbilirubinaemia necessitating treatment, and (2) reduce the need for heel pricks to quantify bilirubin levels. In parallel, we will evaluate a smartphone app (Picterus), and a point-of-care device for quantifying total bilirubin (Bilistick) as compared with LBB.Methods and analysisWe will undertake a multicentre prospective cohort study in nine midwifery practices across the Netherlands. Neonates born at a gestational age of 35 weeks or more are eligible if they: (1) are at home at any time between days 2 and 8 of life; (2) have their first midwife visit prior to postnatal day 6 and (3) did not previously receive phototherapy. TcB and the Picterus app will be used after visual inspection. When LBB is deemed necessary based on visual inspection and/or TcB reading, Bilistick will be used in parallel. The coprimary endpoints of the study are: (1) hyperbilirubinaemia necessitating treatment; (2) the number of heel pricks performed to quantify LBB. We aim to include 2310 neonates in a 2-year period. Using a decision tree model, a cost-effectiveness analysis will be performed.Ethics and disseminationThis study has been approved by the Medical Research Ethical Committee of the Erasmus MC Rotterdam, Netherlands (MEC-2020-0618). Parents will provide written informed consent. The results of this study will be published in peer-reviewed journals.Trial registration numberDutch Trial Register (NL9545).
To estimate the performance of combining cervical length measurement with fetal fibronectin testing in predicting delivery in women with symptoms of preterm labor.
We conducted a prospective ...nationwide cohort study in all 10 perinatal centers in The Netherlands. Women with symptoms of preterm labor between 24 and 34 weeks of gestation with intact membranes were included. In all women, qualitative fibronectin testing (0.050-microgram/mL cutoff) and cervical length measurement were performed. Logistic regression was used to predict spontaneous preterm delivery within 7 days after testing. A risk less than 5%, corresponding to the risk for women with a cervical length of at least 25 mm, was considered as low risk.
Between December 2009 and August 2012, 714 women were enrolled. Fibronectin results and cervical length were available for 665 women, of whom 80 (12%) delivered within 7 days. Women with a cervical length of at least 30 mm or with a cervical length between 15 and 30 mm with a negative fibronectin result were at low risk (less than 5%) of spontaneous delivery within 7 days. Fibronectin testing in case of a cervical length between 15 and 30 mm additionally classified 103 women (15% of the cohort) as low risk and 36 women (5% of the cohort) as high risk.
Cervical length measurement, combined with fetal fibronectin testing in case of a cervical length between 15 and 30 mm, improves identification of women with a low risk to deliver spontaneously within 7 days.
II.
Objective The purpose of this study was to assess the relationship between neonatal respiratory morbidity and the interval between antenatal corticosteroids (ACS) administration and birth. Study ...Design We performed a retrospective cohort study among women who had received ACS and delivered at <34 weeks of gestation. We categorized these women in 4 groups: ACS-to-delivery interval of 0-7, 8-14, 15-21, and 22-28 days. Multivariable logistic regression analysis assessed the association between the ACS-to-delivery interval and neonatal respiratory morbidity. Results We included 254 neonates. Eighty-two neonates (32%) were intubated. In comparison with neonates with an ACS-to-delivery interval of 0-7 days, the risk for intubation was increased in all other groups (odds ratio OR, 2.3; 95% confidence interval CI, 1.1–5.4; OR, 5.6; 95% CI, 1.8–18; and OR, 4.8; 95% CI, 0.71–32, not statistically significant, respectively). Conclusion The effect of ACS decreases when the ACS-to-delivery interval exceeds 7 days. The first administration of ACS should be considered carefully.
The aim of this study is to assess if women with arrested preterm labor (PTL) have an increased risk of preterm delivery (PTD) compared with healthy pregnant women, and if digital examination, fetal ...fibronectin (fFn) and cervical length (CL) are prognostic markers for PTD after arrested PTL.
Prospective-matched cohort study among women with arrested PTL (cases) and healthy pregnant women (controls).
We included 74 index cases and 74 controls. PTD occurred in 20 (27%) index cases and in 5 (7%) controls (hazard ratio HR, 4.5; 95% confidence interval CI, 1.7-12). A dilatation of the cervix ≥ 1 cm (HR, 9.1 95% CI, 3.3-25, an fFn positive status (HR, 13 95% CI, 4.3-40), and a CL < 15 mm (HR, 11 95% CI, 3.1-38) increased this risk in cases compared with controls. Knowledge of the fFn result had additional value over the cervical dilatation or CL in the prediction of persistent PTD, with an increased risk in case of a positive fFn test.
Women stay at increased risk for PTD after arrested PTL. This risk further increased in case of ≥ 1 cm cervical dilatation, CL < 15 mm and/or a positive fFn status.
The optimal time interval between administration of antenatal corticosteroids and delivery is 1 to 7 days. This study evaluates the timing of the first course of antenatal corticosteroids in clinical ...practice. We performed a retrospective cohort study of consecutive women who had received antenatal corticosteroids and/or delivered between 24 and 34 weeks of gestation. Time between administration of corticosteroids and delivery was compared between women with different causes of anticipated preterm deliveries: symptomatic preterm labor with intact membranes; preterm premature rupture of the membranes; (pre)eclampsia; hemolysis, elevated liver enzymes, and low platelet count; intrauterine growth restriction; vaginal blood loss; and suspected fetal distress. We included 439 women of whom 348 (79%) completed the course of corticosteroids. In women with a complete course, 143 (41%) delivered within 7 days. The median interval between the course and delivery was 11 days and varied between 41 days in women with vaginal blood loss, 25 days in women with spontaneous preterm labor with intact membranes, and 8 days in women with preeclampsia ( P < 0.001). In women with spontaneous preterm labor with intact membranes and in women with vaginal blood loss, we can benefit substantially from a more accurate discrimination of women who need corticosteroids immediately and women who do not.
Objective
To stratify the risk of spontaneous preterm delivery using cervical length (CL) and fetal fibronectin (fFN) in women with threatened preterm labor who remained pregnant after 7 days.
Design
...Prospective observational study.
Setting
Nationwide cohort of women with threatened preterm labor from the Netherlands.
Population
Women with threatened preterm labor between 24 and 34 weeks with a valid CL and fFN measurement and remaining pregnant 7 days after admission.
Methods
Kaplan–Meier and Cox proportional hazards models were used to estimate cumulative percentages and hazard ratios (HR) for spontaneous delivery.
Main outcome measures
Spontaneous delivery between 7 and 14 days after initial presentation and spontaneous preterm delivery before 34 weeks.
Results
The risk of delivery between 7 and 14 days was significantly increased for women with a CL < 15 mm or a CL ≥15 to <30 mm and a positive fFN, compared with women with a CL ≥30 mm: HR 22.3 95% confidence interval (CI) 2.6–191 and 14 (95% CI 1.8–118), respectively. For spontaneous preterm delivery before 34 weeks the risk was increased for women with a CL < 15 mm HR 6.3 (95% CI 2.6–15) or with a CL ≥15 to <30 mm with either positive fFN HR 3.6 (95% CI 1.5–8.7) or negative fFN HR 3.0 (95% CI 1.2–7.1) compared with women with a CL ≥ 30 mm.
Conclusions
In women remaining pregnant 7 days after threatened preterm labor, CL and fFN results can be used in risk stratification for spontaneous delivery.
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