scholarly journals Impact of replacing or adding placental growth factor on Down syndrome screening: a prospective cohort study

2020 ◽  
Author(s):  
Wing To Angela Sin ◽  
Liona Poon ◽  
Piya Chaemsaithong ◽  
Yi Man Wah ◽  
Shuk Yi Annie Hui ◽  
...  
Keyword(s):  
Growth Factor ◽  
Test Performance ◽  
Trisomy 21 ◽  
Detection Rate ◽  
False Positive Rate ◽  
First Trimester ◽  
Placental Growth Factor ◽  
Singleton Pregnancy ◽  
Combined Test ◽  
Positive Rate

Objectives: To assess whether adding placental growth factor (PlGF) or replacing pregnancy-associated plasma protein-A (PAPP-A) improves the first trimester combined test performance for trisomy 21. Design: Prospective observation Cohort Setting: The Chinese University of Hong Kong, China Sample: 11,518 women having a singleton pregnancy screened for trisomy 21 between December 2016 and December 2019 using the first trimester combined test. Methods: PlGF was prospectively measured and estimated term risk for trisomy 21 was calculated by 1) replacing PAPP-A with PlGF and 2) adding PlGF to the combined test which includes nuchal translucency, PAPP-A and free β-human chorionic gonadotropin (hCG). Main Outcome Measure: Screening performance, area under curve (AUC), detection rate (DR), screen positive rate (SPR) and false positive rate (FPR) Results: 29 women had trisomy 21. The combined tests DR, FPR and SPR were 89.7%, 5.7% and 6% respectively. DR when replacing PAPP-A or adding PlGF to the combined test remained unchanged. Replacing PAPP-A by PlGF increased FPR and SPR to 6.2% and 6.4% respectively. Adding PlGF to the combined test gave FPR and SPR rates of 5.5% and 5.7% respectively. Adding or replacing PlGF did not give a significant increase in AUC (p>0.48) over that of the combined test. Conclusion: Adding PlGF to the combined test or replacing PAPP-A with PlGF in the combined test did not improve trisomy 21 detection rate. Replacing PAPP-A by PlGF increased SPR, whilst adding PlGF resulted in only a marginal reduction in SPR.

scholarly journals Clinical and Economic Evaluation after Adopting Contingent Cell-Free DNA Screening for Fetal Trisomies in South Spain

2020 ◽  
Vol 47 (10) ◽  
pp. 749-756
Author(s):  
José A. Sainz ◽  
María R. Torres ◽  
Ignacio Peral ◽  
Reyes Granell ◽  
Manuel Vargas ◽  
...  
Keyword(s):  
False Positive Rate ◽  
Cost Effective ◽  
First Trimester ◽  
Nuchal Translucency ◽  
University Hospitals ◽  
Combined Test ◽  
Positive Rate ◽  
Fetal Malformations ◽  
Cfdna Screening ◽  
Singleton Pregnancies

<b><i>Introduction:</i></b> Contingent cell-free (cf) DNA screening on the basis of the first-trimester combined test (FCT) results has emerged as a cost-effective strategy for screening of trisomy 21 (T21). <b><i>Objectives:</i></b> To assess performance, patients’ uptake, and cost of contingent cfDNA screening and to compare them with those of the established FCT. <b><i>Methods:</i></b> This is a prospective cohort study including all singleton pregnancies attending to their FCT for screening of T21 at 2 university hospitals in South Spain. When the FCT risk was ≥1:50, there were major fetal malformations, or the nuchal translucency was ≥3.5 mm, women were recommended invasive testing (IT); if the risk was between 1:50 and 1:270, women were recommended cfDNA testing; and for risks bellow 1:270, no further testing was recommended. Detection rate (DR), false-positive rate (FPR), patients’ uptake, and associated costs were evaluated. <b><i>Results:</i></b> We analyzed 10,541 women, including 46 T21 cases. DR of our contingent strategy was 89.1% (41/46) at 1.4% (146/10,541) FPR. Uptake of cfDNA testing was 91.2% (340/373), and overall IT rate was 2.0%. The total cost of our strategy was €1,462,895.7, similar to €1,446,525.7 had cfDNA testing not been available. <b><i>Conclusions:</i></b> Contingent cfDNA screening shows high DR, low IT rate, and high uptake at a similar cost than traditional screening.

scholarly journals Predicting first-trimester outcome of embryos with cardiac activity in women with recurrent spontaneous abortion

2020 ◽  
Vol 48 (6) ◽  
pp. 030006052091182
Author(s):  
Huixian Li ◽  
Shuang Qin ◽  
Fanfan Xiao ◽  
Yuhong Li ◽  
Yunhe Gao ◽  
...  
Keyword(s):  
Pregnant Women ◽  
False Positive ◽  
Detection Rate ◽  
False Positive Rate ◽  
Cardiac Activity ◽  
First Trimester ◽  
Clinical Indicators ◽  
Early Outcome ◽  
Heart Motion ◽  
Positive Rate

Objective This study was performed to evaluate the capability of routine clinical indicators to predict the early outcome of embryos with cardiac activity in women with recurrent spontaneous abortion (RSA). Methods A retrospective cohort study of pregnant women with a history of RSA in a Chinese tertiary hospital was performed using unadjusted and multivariable logistic regression. Results Of 789 pregnant women with RSA, 625 (79.21%) had ongoing pregnancy, whereas 164 (20.79%) developed abortion before 20 full weeks of gestational age even after embryonic heart motion was detected. The final model had an area under the curve of 0.81 (95% confidence interval, 0.78–0.84) with a sensitivity of 74.39%, a specificity of 76.00%, and a false-positive rate of 52.32% at a fixed detection rate of 90%. Conclusions The combination of multiple routine clinical indicators was valuable in predicting the early outcome of embryos with cardiac activity in viable pregnancies with RSA. However, this model might result in a high false-positive rate with a fixed detection rate of 90%; other markers must be investigated to identify first-trimester RSA once positive embryonic heart motion is established.

Performance characteristics of Elecsys free βhCG and PAPP-A for first trimester trisomy 21 risk assessment in gestational weeks 8+0 to 14+0

2016 ◽  
Vol 0 (0) ◽  
Author(s):  
Niels Tørring ◽  
Carlos Aulesa ◽  
Bernd Eiben ◽  
Mª José Ferri ◽  
Kypros H. Nicolaides ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Trisomy 21 ◽  
False Positive Rate ◽  
Protein A ◽  
First Trimester ◽  
Nuchal Translucency ◽  
Serological Markers ◽  
Cross Sectional ◽  
Positive Rate ◽  
Technical Validation

AbstractScreening for fetal trisomy 21 (T21) in the first trimester includes analysis of the serological markers pregnancy-associated plasma protein A (PAPP-A) and free β-choriogonadotropin (free βhCG). With the recent launch of these assays on the cobas e and Elecsys platforms, we investigated their clinical and analytical performance.We conducted a multicenter study in 5397 pregnancies including 108 cross-sectional collected repository cases with verified fetal T21 at 8–14 weeks of gestation. A technical validation of the Roche ElecsysThe imprecision of the Elecsys free βhCG and PAPP-A assays was between 1.0% and 2.8%, and both assays showed correlation to Kryptor (free βhCG 0.981; PAPP-A 0.987), AutoDELFIA (free βhCG 0.995; PAPP-A 0.979) and IMMULITE assays (free βhCG 0.983; PAPP-A 0.983). With a cut off at 1:300 the overall sensitivity of the screening including nuchal translucency reached 94% for a 3% false positive rate.The Roche Elecsys free βhCG and PAPP-A are suitable and reliable assays for first trimester T21 risk assessment. Both assays were approved and recommended by the FMF.

scholarly journals Early first-trimester maternal serum placental growth factor in trisomy 21 pregnancies

2011 ◽  
Vol 37 (5) ◽  
pp. 515-519 ◽  
Author(s):  
N. J. Cowans ◽  
A. Stamatopoulou ◽  
N. Tørring ◽  
K. Spencer
Keyword(s):  
Growth Factor ◽  
Trisomy 21 ◽  
First Trimester ◽  
Maternal Serum ◽  
Placental Growth Factor

First trimester Down's syndrome screening marker values and cigarette smoking: new data and a meta-analysis on free β human chorionic gonadotophin, pregnancy-associated plasma protein-A and nuchal translucency

2008 ◽  
Vol 15 (4) ◽  
pp. 204-206 ◽  
Author(s):  
Jonathan P Bestwick ◽  
Wayne J Huttly ◽  
Nicholas J Wald
Keyword(s):  
Meta Analysis ◽  
False Positive Rate ◽  
Protein A ◽  
First Trimester ◽  
Nuchal Translucency ◽  
Screening Performance ◽  
Combined Test ◽  
Positive Rate ◽  
Trimester Screening ◽  
Β Hcg

Objectives To examine the effect of smoking on three first trimester screening markers for Down's syndrome that constitute the Combined test, namely nuchal translucency (NT), pregnancy-associated plasma protein-A (PAPP-A) and free β human chorionic gonadotophin (free β-hCG) and to use the results to determine which of these markers need to be adjusted for smoking and by how much. Methods The difference in the median multiple of the median (MoM) values in smokers compared to non-smokers was determined for NT, PAPP-A and free β-hCG in 12,517 unaffected pregnancies that had routine first trimester Combined test screening. These results were then included in a meta-analysis of published studies and the effect of adjusting for smoking on screening performance of the Combined test was estimated. Results The results using the routine screening data were similar to the summary estimates from the meta-analysis of all studies. The results from the meta-analysis were; median MoM in smokers compared to non-smokers: 1.06 NT (95% confidence interval 1.03 to 1.10), 0.81 PAPP-A (0.80 to 0.83) and 0.94 free β-hCG (0.89 to 0.99). The effect of adjusting for smoking on the Combined test is small, with an estimated less than half percentage point increase in the detection rate (the proportion of affected pregnancies with a positive result) for a 3% false-positive rate (the proportion of unaffected pregnancies with a positive result) and less than 0.2 percentage point decrease in the false-positive rate for an 85% detection rate. Conclusion Adjusting first trimester screening markers for smoking has a minimal favourable effect on screening performance, but it is simple to implement and this paper provides the adjustment factors needed if a decision is made to make such an adjustment.

scholarly journals Clinical and Pathogenetic Causes of Developing Complications in Multiple Pregnancy

2020 ◽  
Vol 27 (1) ◽  
pp. E202016
Author(s):  
Iryna Nikitina ◽  
Volodymyr Boiko ◽  
Tetiana Babar ◽  
Natalia Kalashnik ◽  
Nataliia Ikonopistseva ◽  
...  
Keyword(s):  
Growth Factor ◽  
Pregnant Women ◽  
Multiple Pregnancy ◽  
First Trimester ◽  
Placental Growth Factor ◽  
Enzyme Linked Immunosorbent Assay ◽  
Full Time ◽  
Singleton Pregnancy ◽  
Placental Dysfunction ◽  
First Trimester Of Pregnancy

To assess the role of the placental growth factor in the development of gestational complications during multiple pregnancy, there was conducted a study of this indicator in serum of 320 pregnant women with multiple pregnancy in the first trimester and 40 pregnant women with singleton pregnancy (the control group).          The objective of the research was to study the effect of placental growth factors on the gestational process in multiple pregnancy.          Materials and Methods. There was conducted a prospective study of pregnancy and childbirth in 320 females with multiple pregnancy (the main group) and 40 healthy women with singleton pregnancy. The level of serum placental growth factor was determined by enzyme-linked immunosorbent assay using monoclonal antibodies in the first trimester of pregnancy. The indicators of the hemostasis system (vascular, platelet and coagulation components) were evaluated according to generally accepted methods. Doppler ultrasound of the placental and fetal blood flow was performed in the uterine arteries, the umbilical artery and vein, the fetal middle cerebral artery.          Results. Women with multiple pregnancy were at high risk of developing gestational complications such as preterm deliveries (67.8%, p<0.01), placental dysfunction, pre-eclampsia (17.5%, p<0.05). The disorders of the vascular platelet and coagulation hemostasis in the first trimester of pregnancy were the main risk factors for early termination of pregnancy. Low level of serum placental growth factor in pregnant women with multiple pregnancy in case of preterm delivery, placental dysfunction and pre-eclampsia (111.23 ± 8.4, 203.24 ± 6.4 and 305.86 ± 7.4 pg/ml), in comparison with the corresponding indicators in singleton pregnancy (418.2 ± 10.4 pg/ml), was proven to be a prognostic marker for the development of gestational complications.          Conclusions. Timely correction of gestational complications in multiple pregnancy with micronized progesterone, low molecular weight heparins, angio-protective agents allowed us to prolong pregnancy with monochorionic placentation type for 3.2 weeks (up to 34.2 ± 2.4 weeks) and provide full-time delivery of dichorionic twin pregnancy.

Placental protein-13 (PP13) in combination with PAPP-A and free leptin index (fLI) in first trimester maternal serum screening for severe and early preeclampsia

2017 ◽  
Vol 56 (1) ◽  
Author(s):  
Carin P. De Villiers ◽  
Paula L. Hedley ◽  
Sophie Placing ◽  
Karen R. Wøjdemann ◽  
Anne-Cathrine Shalmi ◽  
...  
Keyword(s):  
Detection Rate ◽  
False Positive Rate ◽  
First Trimester ◽  
Serum Marker ◽  
Maternal Serum ◽  
Maternal Serum Screening ◽  
Discriminatory Ability ◽  
Screening Performance ◽  
Positive Rate ◽  
Placental Protein

AbstractBackground:Placental protein-13 (PP13) is involved in placental invasion and has been suggested as a maternal serum marker of preeclampsia (PE) development. However, the discriminatory ability of PP13 in first trimester has not been completely clarified.Methods:PP13 was measured in first trimester (week 10Results:In severe PE (including HELLP) cases (n=26) the median PP13 concentration was 35.8 pg/mL (range: 17.8–85.5 pg/mL) and in PE pregnancies (n=10) with birth prior to week 34, the median PP13 concentration was 30.6 pg/mL (13.1–50.1 pg/mL), compared to controls with a median of 54.8 pg/mL (range: 15.4–142.6 pg/mL) (p<0.04). The population screening detection rate (DR) for a false-positive rate of 10% for severe PE and HELLP was 26% for PP13, 28% for PP13+PAPP-A, 33% for PP13+fLI, and 40% for PP13+PAPP-A+fLI.Conclusions:PP13 is a marker of severe PE and HELLP syndrome. The screening performance of PP13 can be markedly improved by combining it with fLI and PAPP-A.

How Effective Is First-Trimester Screening for Trisomy 21 Based on Ultrasound Only?

2015 ◽  
Vol 39 (2) ◽  
pp. 105-112 ◽  
Author(s):  
Marcin Wiechec ◽  
Anna Knafel ◽  
Agnieszka Nocun ◽  
Anna Matyszkiewicz ◽  
Magdalena Juszczak ◽  
...  
Keyword(s):  
Trisomy 21 ◽  
False Positive Rate ◽  
First Trimester ◽  
Nuchal Translucency ◽  
Cardiac Anomaly ◽  
Screening Methods ◽  
Detection Rates ◽  
Comparable Performance ◽  
Positive Rate ◽  
A Prospective Study

Objective: To evaluate the most common first-trimester ultrasound features of fetuses with trisomy 21 (T21) and to examine the screening performance for Down syndrome (DS) using only ultrasound-based protocols. To investigate whether maternal age (MA) has an impact on the efficacy of the ultrasound-based screening methods. Methods: In a prospective study, 6,265 patients were examined. Two ultrasound-based risk calculation protocols were applied: ‘NT' (based on nuchal translucency) and ‘NT+' (based on NT and secondary markers). Results: A total of 5,696 patients were enrolled for analysis; 84 subjects with T21 were identified. Combinations of abnormal ultrasound markers were observed in only 1.2% of euploid fetuses compared to 71.5% of fetuses with T21. Among 17.9% of DS cases with cardiac anomaly, 14.3% comprised atrioventricular septal defects. For a false-positive rate of 3%, the detection rates of T21 were 73.8 and 91.7% for the ‘NT' and ‘NT+' protocols, respectively. The efficacy of both methods was affected by MA. Conclusions: Most of the fetuses with DS demonstrate a combination of ultrasound markers of aneuploidy in the first trimester. The ‘NT+' protocol is efficient and provides comparable performance as a combined screening test. It is a valuable method, especially when the access to biochemical analysis is restricted.

scholarly journals First trimester ultrasound screening of chromosomal abnormalities

2007 ◽  
Vol 135 (3-4) ◽  
pp. 153-156 ◽  
Author(s):  
Aleksandra Trninic-Pjevic ◽  
Aleksandra Novakov-Mikic
Keyword(s):  
Maternal Age ◽  
Detection Rate ◽  
Chromosomal Abnormalities ◽  
False Positive Rate ◽  
First Trimester ◽  
Nuchal Translucency ◽  
Ultrasound Screening ◽  
Positive Rate ◽  
Chromosomal Defects ◽  
First Trimester Ultrasound

Introduction: A retrocervical subcutaneous collection of fluid at 11-14 weeks of gestation, can be visualized by ultrasound as nuchal translucency (NT). Objective. To examine the distribution of fetal nuchal translucency in low risk population, to determine the detection rate of chromosomal abnormalities in the population of interest based on maternal age and NT measurement. Method. Screening for chromosomal defects, advocated by The Fetal Medicine Foundation (FMF), was performed in 1,341 pregnancies in the period January 2000 - April 2004. Initial risk for chromosomal defects (based on maternal and gestational age) and corrected risk, after the NT measurement, were calculated. Complete data were collected from 1,048 patients. Results. Out of 1,048 pregnancies followed, 8 cases of Down?s syndrome were observed, 7 were detected antenatally and 6 out of 7 were detected due to screening that combines maternal age and NT measurement. According to our results, sensitivity of the screening for aneuploidies based on maternal age alone was 12.5% and false positive rate 13.1%, showing that screening based on NT measurement is of great importance. Screening by a combination of maternal age and NT, and selecting a screening-positive group for invasive testing enabled detection of 75% of fetuses with trisomy 21. Conclusion. In screening for chromosomal abnormalities, an approach which combines maternal age and NT is effective and increases the detection rate compared to the use of any single test. .

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