Pre‐eclampsia screening in Denmark (<scp>PRESIDE</scp>): national validation study

Riishede, I.; Rode, Line; Sperling, Lene; Overgaard, Martin; Ravn, Julie Dahl; Sandager, Puk; Skov, Hans J.; Wagner, Stefan; Nørgaard, P.; Clausen, Tine Dalsgaard; Jensen, C A Juel; Pihl, Kasper; Jørgensen, Finn Stener; Munk, J.; Zingenberg, Helle; Pedersen, Natalia; Andersen, Malene R.; Wright, A.; Wright, David; Tabor, Ann; Ekelund, Charlotte Kvist

doi:10.1002/uog.26183

Cited by 14 publications

(24 citation statements)

References 50 publications

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“…The finding of this study that the triple test is among the best-performing screening strategies for preterm PE is consistent with the results of previous studies 5,7,[20][21][22][23][24][25] . Likewise, it was shown previously that the predictive performance of the triple test for term PE was poor.…”

Section: Comparison With Findings Of Previous Studiessupporting

confidence: 93%

Screening for pre‐eclampsia by maternal serum glycosylated fibronectin at 11−13 weeks' gestation

Sokratous,

Bednorz,

Sarli

et al. 2023

Ultrasound in Obstet & Gyne

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ObjectiveTo examine the performance of screening for preterm‐ and term‐preeclampsia (PE) at 11‐13 weeks' gestation by maternal factors and combinations of maternal serum glycosylated fibronectin (GlyFn), mean arterial pressure (MAP), uterine artery pulsatility index (UtA‐PI) and serum placental growth factor (PlGF).MethodsThis was a case‐control study in which maternal serum GlyFn was measured in stored samples from a non‐intervention screening study in singleton pregnancies at 11+0 – 13+6 weeks' gestation using a point‐of‐care device. In the same samples PlGF was measured by time‐resolved fluorometry. We used samples from women who delivered with PE at <37 weeks' gestation (n=100), PE at ≥37 weeks (n=100), gestational hypertension (GH) at <37 weeks (n=100), GH at ≥37 weeks (n=100), and 1,000 normotensive controls with no pregnancy complications. In all cases MAP and UtA‐PI had been measured during the routine 11+0 – 13+6 weeks visit of the women. Levels of GlyFn were transformed to multiple of the expected median value (MoM) after adjusting for maternal demographic characteristics and elements from the medical history. Similarly, the measured values of MAP, UtA‐PI and PlGF were converted to MoMs. The competing risks model was used to combine the prior distribution of the gestational age at delivery with PE, obtained from maternal characteristics, with various combinations of biomarker MoM values to derive the patient‐specific risks of delivery with PE or GH at <37 and ≥37 weeks' gestation. The performance of screening was estimated by examining the area under the receiver operating characteristic curve (AUC) and detection rate (DR) at 10% fixed false‐positive rate (FPR).ResultsThe variables from maternal characteristics and medical history with significant contribution to the measurement of GlyFn were maternal age, weight, height, race, smoking and previous history of PE. In pregnancies that developed PE, GlyFn MoM was increased and the deviation from normal decreased with increasing gestational age at delivery. The DR and AUC for delivery with PE at <37 weeks' gestation in screening by maternal factors alone were 50% and 0.834, respectively, and these increased to 80% and 0.949, respectively, when maternal risk factors were combined with MAP, UtA‐PI and PlGF (triple test). The performance of the triple test was similar to that of screening by a combination of maternal factors with MAP, UtA‐PI and GlyFn (DR 79% and AUC 0.946) and in screening by a combination of maternal factors with MAP, PlGF and GlyFn (DR 81% and AUC 0.932). The performance of screening for delivery with PE at ≥37 weeks'gestation was poor with DRs of 35% in screening with maternal factors alone, increasing to only 39% with use of the triple test; Similar results were obtained when GlyFn replaced PlGF or UtA‐PI in the triple test. The DRs, at 10% FPR, of GH with delivery at <37 and ≥37 weeks'gestation in screening by maternal factors alone were 34% and 25%, respectively, and these increased to 54% and 31%, respectively in screening by the triple test; similar results were obtained when GlyFn replaced PlGF or UtA‐PI in the triple test.ConclusionGlyFn is a potentially useful biomarker in first trimester screening for preterm‐PE, but the results of this case‐control study need to be validated by prospective screening studies. The performance of screening for term PE or GH at 11+0 to 13+6 weeks by any combination of biomarkers is poor.This article is protected by copyright. All rights reserved.

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Section: Comparison With Findings Of Previous Studiessupporting

confidence: 93%

Screening for pre‐eclampsia by maternal serum glycosylated fibronectin at 11−13 weeks' gestation

Sokratous,

Bednorz,

Sarli

et al. 2023

Ultrasound in Obstet & Gyne

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“…13 A double-blind, placebo-controlled trial of low-dose aspirin (81 mg daily) versus placebo from 6 to 13 weeks of gestation until 36 weeks in 11 976 nulliparous women with singleton pregnancies found that aspirin was associated with an 11% reduction in the risk of PTB at <37 weeks of gestation (RR 0.89, 95% CI 0.81-0.98) but the study did not provide data as to whether the PTB was spontaneous or iatrogenic and whether there was any association with pre-eclampsia. 26 In our study, we demonstrated the poor or no impact of aspirin in sPTB and iPTB in the absence of pre-eclampsia and the high impact on the prevention of iPTB associated with pre-eclampsia.…”

Section: Outcome Measurementioning

confidence: 50%

“…2,6,20 The model, which was originally described in 2012, was subsequently validated in many studies in the UK and other countries that reported high predictive performance for preterm pre-eclampsia and good agreement between estimated risk and observed incidence of the disease. [21][22][23][24][25][26][27] In the absence of serum PlGF, serum PAPP-A can be used, but the performance of the latter is poor by comparison with PlGF. 28 Additionally, the studies reported that in screening for pre-eclampsia it is a necessity to establish a programme for continuous quality assurance of biomarker measurements, as is the case in screening for fetal trisomies in the UK.…”

Section: Interpretation Of Results and Implications For Clinical Prac...mentioning

confidence: 99%

“…A Swedish register‐based cohort study investigated the association between low‐dose aspirin use and PTB among 22 127 women with a previous PTB and concluded that low‐dose aspirin use was associated with a reduced risk for sPTB (relative risk [RR] 0.70; 95% CI 0.57–0.86) but had no significant effect on iPTB (RR 1.09; 95% CI 0.91–1.30) 13 . A double‐blind, placebo‐controlled trial of low‐dose aspirin (81 mg daily) versus placebo from 6 to 13 weeks of gestation until 36 weeks in 11 976 nulliparous women with singleton pregnancies found that aspirin was associated with an 11% reduction in the risk of PTB at <37 weeks of gestation (RR 0.89, 95% CI 0.81–0.98) but the study did not provide data as to whether the PTB was spontaneous or iatrogenic and whether there was any association with pre‐eclampsia 26 . In our study, we demonstrated the poor or no impact of aspirin in sPTB and iPTB in the absence of pre‐eclampsia and the high impact on the prevention of iPTB associated with pre‐eclampsia.…”

Section: Discussionmentioning

confidence: 99%

“…The FMF triple test provides effective first‐trimester prediction of preterm pre‐eclampsia and treatment of the high‐risk group with aspirin substantially reduces the incidence of the disease 2,6,20 . The model, which was originally described in 2012, was subsequently validated in many studies in the UK and other countries that reported high predictive performance for preterm pre‐eclampsia and good agreement between estimated risk and observed incidence of the disease 21‐27 . In the absence of serum PlGF, serum PAPP‐A can be used, but the performance of the latter is poor by comparison with PlGF 28 .…”

Section: Discussionmentioning

confidence: 99%

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First‐trimester prediction of preterm pre‐eclampsia and prophylaxis by aspirin: Effect on spontaneous and iatrogenic preterm birth

Nicolaides,

Syngelaki,

Poon

et al. 2023

BJOG

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ObjectiveTo report the predictive performance for preterm birth (PTB) of the Fetal Medicine Foundation (FMF) triple test and National Institute for health and Care Excellence (NICE) guidelines used to screen for pre‐eclampsia and examine the impact of aspirin in the prevention of PTB.DesignSecondary analysis of data from the SPREE study and the ASPRE trial.SettingMulticentre studies.PopulationIn SPREE, women with singleton pregnancies had screening for preterm pre‐eclampsia at 11–13 weeks of gestation by the FMF method and NICE guidelines. There were 16 451 pregnancies that resulted in delivery at ≥24 weeks of gestation and these data were used to derive the predictive performance for PTB of the two methods of screening. The results from the ASPRE trial were used to examine the effect of aspirin in the prevention of PTB in the population from SPREE.MethodsComparison of performance of FMF method and NICE guidelines for pre‐eclampsia in the prediction of PTB and use of aspirin in prevention of PTB.Main outcome measureSpontaneous PTB (sPTB), iatrogenic PTB for pre‐eclampsia (iPTB‐PE) and iatrogenic PTB for reasons other than pre‐eclampsia (iPTB‐noPE).ResultsEstimated incidence rates of sPTB, iPTB‐PE and iPTB‐noPE were 3.4%, 0.8% and 1.6%, respectively. The corresponding detection rates were 17%, 82% and 25% for the triple test and 12%, 39% and 19% for NICE guidelines, using the same overall screen positive rate of 10.2%. The estimated proportions prevented by aspirin were 14%, 65% and 0%, respectively.ConclusionPrediction of sPTB and iPTB‐noPE by the triple test was poor and poorer by the NICE guidelines. Neither sPTB nor iPTB‐noPE was reduced substantially by aspirin.

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Adverse Obstetric Outcomes in Pregnancies With Major Fetal Congenital Heart Defects

Hedermann,

Hedley,

Gadsbøll

et al. 2024

JAMA Pediatr

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ImportanceUnderstanding the risk profile of obstetric complications in pregnancies with fetal major congenital heart defects (MCHDs) is crucial for obstetric counseling and care.ObjectiveTo investigate the risk of placenta-related adverse obstetric outcomes in pregnancies complicated by fetal MCHDs.Design, Setting, and ParticipantsThis cohort study retrieved data from June 1, 2008, to June 1, 2018, from the Danish Fetal Medicine Database, which includes comprehensive data on more than 95% of all pregnancies in Denmark since the database was instituted in 2008. All singleton pregnancies that resulted in a live-born child after 24 weeks’ gestation without chromosomal aberrations were included. A systematic search of the literature was performed in PubMed, Embase, and the Cochrane Library from inception to June 1, 2024, to compile existing knowledge and data on adverse obstetric outcomes among MCHD subtypes.ExposureFetal MCHDs including 1 of 11 subtypes.Main Outcomes and MeasuresThe primary outcome was a composite adverse obstetric outcome defined as preeclampsia, preterm birth, fetal growth restriction, or placental abruption. Secondary outcomes consisted of each adverse obstetric event. Adjusted odds ratios (AORs) were computed using generalized estimating equations adjusted for maternal body mass index, age, smoking, and year of delivery. Meta-analyses were conducted using random-effects models to pool effect sizes for each MCHD subtype and adverse obstetric outcome.ResultsA total of 534 170 pregnancies were included in the Danish cohort, including 745 with isolated fetal MCHDs (median [IQR] maternal age, 29.0 [26.0-33.0] years) and 533 425 without MCHDs (median [IQR] maternal age, 30.0 [26.0-33.0] years). Pregnancies with fetal MCHDs exhibited a higher rate of adverse obstetric outcomes at 22.8% compared with 9.0% in pregnancies without fetal MCHDs (AOR, 2.96; 95% CI, 2.49-3.53). Preeclampsia (AOR, 1.83; 95% CI, 1.33-2.51), preterm birth at less than 37 weeks (AOR, 3.84; 95% CI, 3.15-4.71), and fetal growth restriction (AOR, 3.25; 95% CI, 2.42-4.38) occurred significantly more frequently in pregnancies with MCHDs. Except for fetal transposition of the great arteries (AOR, 1.19; 95% CI, 0.66-2.15), all MCHD subtypes carried a greater risk of adverse obstetric outcomes. The meta-analysis included 10 additional studies that supported these results.Conclusions and RelevanceThese findings suggest that nearly 1 in 4 women expecting a child with an MCHD, except transposition of the great arteries, may be at high risk of adverse obstetric outcomes.

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Pre‐eclampsia screening in Denmark (PRESIDE): national validation study

Cited by 14 publications

References 50 publications

Screening for pre‐eclampsia by maternal serum glycosylated fibronectin at 11−13 weeks' gestation

Screening for pre‐eclampsia by maternal serum glycosylated fibronectin at 11−13 weeks' gestation

First‐trimester prediction of preterm pre‐eclampsia and prophylaxis by aspirin: Effect on spontaneous and iatrogenic preterm birth

Adverse Obstetric Outcomes in Pregnancies With Major Fetal Congenital Heart Defects

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