ABSTRACT
AIM: The aim of this work was to assess the risk of early fetal loss (first trimester of pregnancy, 8-13 weeks of gestation) using the results of first-trimester screening (FTS) biochemical markers independently and combined. METHODS: FTS results of 152 women who suffered early fetal loss were compared to a control group of 150 women with normal pregnancy outcomes. FTS biochemical markers were measured with a Delfia Xpress 6000 analyzer and biochemical risks for Down's and Edward's syndromes were calculated using Prenatal-Lifecycle version 3.0 software. Marker levels were standardized by calculating the gestational-specific multiple of the medians (MoM), further adjusted by maternal age, maternal weight, cigarette consumption and pre-existing type 1 diabetes mellitus. Receiver-operator curves were built to evaluate each marker and its combination. RESULTS: Our results show that values of biochemical risk of t21 of more than 1 in 310 have a poor sensitivity to predict early fetal loss (31.4%) with a positive predictive value (PPV) for fetal loss of 67.7%. Values of pregnancy-associated plasma protein A (PAPP-A) MoM of less than 0.48 show a sensitivity of 62.1% and a PPV of 84.5% for early fetal loss; whereas for free ß-human chorionic gonadotropin, values of MoM of less than 0.44 have a sensitivity of 66.4% with a PPV of 85.3%. A novel algorithm, consisting in the multiplication of both markers, shows for values of less than 0.48 a sensitivity of 83.1%, a specificity of 78.7% and a PPV of 77.1%. CONCLUSION: Combined analysis of PAPP-A and free ß-hCG appears to be a potential candidate to predict early fetal loss.
Subject(s)
Chorionic Gonadotropin, beta Subunit, Human/blood , Fetal Death , Pregnancy-Associated Plasma Protein-A/metabolism , Adult , Biomarkers/blood , Female , Humans , Pregnancy , Retrospective Studies , Risk AssessmentABSTRACT
OBJECTIVE: To evaluate the diagnostic accuracy of different beta-human chorionic gonadotrophin (ß-hCG) levels measurement, for predicting success of medical treatment in cases diagnosed as tubal ectopic pregnancy (TEP). DESIGN: Five-year prospective observational study. SETTING: Prenatal Diagnosis Unit, Vall d'Hebron University Hospital - Barcelona. PATIENTS: TEP cases fulfilling criteria for medical treatment with Methotrexate. INTERVENTIONS: ß-hCG levels were measured on d 0, 4 and 7 of treatment. Results were compared by non-parametrical tests. A ROC curve was plotted to define cut-off points. Diagnostic accuracy of the different measurements was evaluated. MAIN OUTCOME MEASURE: Failure of treatment defined as need for surgical treatment or persistence of high ß-HCG levels despite treatment. RESULTS: 126 women were diagnosed as TEP, eligible for medical treatment. There were no differences in parity, age, previous TEP, or adnexal mass size. Success rate was 88%. ß-HCG decreased significantly more, between days 0-7 and 4-7, in the successful cases. LR for success prediction was 6.2 and 7.8 for ß-HCG levels at days 4 and 7 respectively, 4.02 and 2.47 for decrement between days 0-7 (25%) and 4-7 (20%), respectively. CONCLUSION: ß-hCG cutoff values have a potential for predicting a successful medical treatment of TEP.
Subject(s)
Abortifacient Agents, Nonsteroidal/therapeutic use , Chorionic Gonadotropin, beta Subunit, Human/blood , Methotrexate/therapeutic use , Pregnancy, Ectopic/diagnosis , Pregnancy, Ectopic/drug therapy , Adolescent , Adult , Female , Follow-Up Studies , Humans , Predictive Value of Tests , Pregnancy , Pregnancy, Ectopic/blood , Prognosis , Treatment Outcome , Young AdultABSTRACT
Objetivo: Evaluar los niveles de distribución de los valores bioquímicos de PAPP-A y fßhCG según su edad gestacional, en gestaciones gemelares monocoriónicas y bicoriónicas concebidas espontáneamente en nuestra población. Material y métodos: Se ha estudiado un grupo de 123 gestantes gemelares. Un subgrupo de 72 gestantes gemelares bicoriónicas, con una edad media de 32,1 años, y otro de 41 gestantes gemelares monocoriónicas, con una edad media de 31,1 años. Resultados: Las gestantes gemelares bicoriónicas presentan valores estadísticamente superiores a las monocoriónicas para los valores de las medias de PAPP-A (MoM) (2,55 versus 1,79; p < 0,001) y de fßhCG (MoM) (2,18 versus 1,70; p < 0,001), y no estadísticamente significativos en las medias de la translucencia nucal (Tn) (MoM) (0,96 versus 0,93; p = 0,3). Se analizan las diferentes distribuciones de las concentraciones de las curvas de normalidad de estos parámetros según edad gestacional y corionicidad. Conclusiones: Es necesario determinar ecográficamente si los gemelos son mono- o bicoriónicos ya que hemos comprobado que en nuestra población presentan curvas de normalidad diferenciadas para PAPP-A y fßhCG, utilizadas para el cálculo del riesgo de aneuploidías en el cribado prenatal de primer trimestre (AU)
Objective: To analyse the distribution of PAPP-A and fß-hCG levels in monochorionic and dichorionic twin pregnancies conceived spontaneously in our population. Materials and methods: One hundred twenty-three twin pregnancies were studied. A group of 72 dichorionic twin pregnancies, with an average age of 32.1 years, and another 32 monochorionic twin pregnancies, with an average age of 31.1 years. Results: Dichorionic twin pregnancies conceived spontaneously show values statistically higher than monochorionic of PAPP-A (MoM) (2.55 versus 1.79, P>.001) and fβHCG (MoM) (2.18 versus 1.70, P>.001). There were no significant differences in nuchal traslucency (NT) between both groups (MoM) (0.96 versus 0.93, P=.3). The distributions of PAPP-A and fßhCG levels according the gestation age and chorionic state have been studied. Conclusions: Ultrasound needs to be performed to determine whether twins are mono- or bichorionics as our population has different distribution curves for PAPP-A and fßhCG, which are used to calculate the first trimester prenatal risk (AU)
Subject(s)
Humans , Female , Pregnancy , Pregnancy-Associated Plasma Protein-A/analysis , Pregnancy, Twin/blood , Aneuploidy , Nuchal Translucency Measurement , Mass Screening/methods , Prenatal Diagnosis/methods , Ultrasonography, PrenatalABSTRACT
Objetivo: Evaluar los niveles de proteína plasmática placentaria (PAPP-A) y fracción libre de la βhCG (fßhCG) en gestaciones gemelares bicoriónicas concebidas mediante técnicas de reproducción asistida tipo fertilización in vitro (FIV) o inseminación artificial (IA) en nuestra población. Posterior cálculo de los factores de corrección necesarios a aplicar para el screening de primer trimestre en gestantes gemelares concebidas mediante FIV. Población en estudio: Se han estudiado 171 gestantes gemelares. Un grupo compuesto por 71 gestaciones bicoriónicas concebidas mediante FIV, con una edad media de 36,3 años; un grupo control de 76 gestaciones bicoriónicas concebidas por gestación espontánea, con una edad media de 31,8 años; y un último grupo de 24 gestaciones bicoriónicas concebidas por IA, con una edad media de 32,9 años. Resultados: Las gestantes gemelares bicoriónicas concebidas mediante FIV respecto el grupo control, concebidas espontáneamente, presentan unos niveles estadísticamente inferiores de PAPP-A (2,17 MoM versus 2,41 MoM, p<0,008) y valores superiores no significativos de fßhCG (2,33 MoM versus 2,05 MoM, p=0,144). Las medias de la translucencia nucal (Tn) entre ambos grupos tampoco muestran diferencias significativas (p=0,178). Esta misma tendencia se observa en los valores de PAPPA y fßhCG para las gestaciones concebidas mediante IA, pero con un número menor de gestantes no significativo. Conclusiones: Las mujeres con gestaciones gemelares concebidas por técnicas de reproducción asistida han sido sometidas a tratamientos para la estimulación de la ovulación. Este hecho se ha postulado como una de las causas que podrían explicar la presencia de valores de PAPP-A significativamente inferiores y de fßhCG superiores, aunque no significativos, a las gestantes gemelares espontáneas. Por ello se aconseja la elaboración de curvas propias con gestantes gemelares FIV, o en su defecto, el empleo de factores de corrección para disminuir este efecto. Se comprueba que con la aplicación de estos factores de corrección la tasa de falsos positivos de los gemelares bicoriónicos concebidos por FIV baja de 4,22% a 1,41% en nuestra población, con la consecuente disminución de biopsias de corion que son especialmente complejas en gestaciones gemelares (AU)
Objective: Evaluation of levels of PAPP-A and fßhCG in dichorionic twin pregnancies conceived by Assisted Reproductive Technology, i.e. In Vitro Fertilization (IVF) and Artificicial Insemination (AI) in our population. Calculate the necessary correction factors for first trimester screening in pregnancies conceived by IVF. Study population: One hundred seventyone twin pregnancies were considered within this study. One group was composed by 71 dichorionic twin pregnancies conceived by IVF with an average maternal age of 36.6 years. The control group was composed by 76 dichorionic twin pregnancies conceived spontaneously with an average maternal age of 31.8. A third group was composed by 24 dichorionic twin pregnancies conceived by AI with an average maternal age of 32.9 years. Results: Dichorionic twin pregnancies conceived by IVF present statistically significant lower values for PAPP-A than the control group (2.17 MoM versus 2.41 MoM, p<0.008) and higher values of fßhCG though this difference is not significant (2.33 MoM versus 2.05 MoM, p=0.144). In the other hand, average nuchal translucency (NT) does not show statistical differences between these two groups (p=0.178). Twin pregnancies conceived by AI present these same results tendencies for PAPP-A, fßhCG, and NT, with a lower number of patients not significant. Conclusions: Women with twin pregnancies conceived by Assisted Reproductive Technology (ART) have undergone treatments to induce ovulation. These treatments are proposed as one of the causes that may justify lower PAPP-A values and higher (though not significant) fßhCG values, when twin pregnancies conceived by ART are compared to spontaneously conceived twin pregnancies. Construction of normality curves for twin pregnancies conceived by IVF or calculation of correction factors is advised, in order to decrease this effect in the studied biochemical parameters. Applying these correction factors to our population data, the rate of false positives in first trimester screenings in dichorionic twin pregnancies conceived by IVF is decreased from a 4.22% to a 1.41%; this consequently implies a reduction of chorion biopsies, which are specially complicated in twin pregnancies (AU)
Subject(s)
Humans , Female , Pregnancy , Infant, Newborn , Middle Aged , Pregnancy/genetics , Pregnancy/metabolism , Reproductive Techniques/classification , Reproductive Techniques/instrumentation , Insemination, Artificial/ethics , Insemination, Artificial/genetics , Pregnancy/psychology , Reproductive Techniques/standards , Reproductive Techniques , Insemination, Artificial/methods , Insemination, ArtificialABSTRACT
Objetivo. Evaluar la fiabilidad y la practicabilidad del analizador Delfia Xpress en las técnicas del cribado prenatal del primer y segundo trimestre. Material y métodos. El Delfia Xpress (Perkin-Elmer, Wallac) es un analizador de enzimoinmunoensayo que utiliza el europio como marcador fluorescente específico y que permite la determinación de los parámetros que integran el perfil del cribado prenatal del primer y segundo trimestre; la fracción libre de la β-gonadotrofina coriónica humana libre (fβhCG), la proteína A plasmática asociada al embarazo (PAPP-A), la alfafetoproteína (AFP) y el estriol libre (uE3). Además, el analizador incorpora el software Lifecycle v3.0® para el cálculo del riesgo prenatal de las trisomías 21 y 18, con conexión bidireccional con el sistema informático del laboratorio. Se procesaron 3.020 muestras de cribados del primer trimestre y 678 del segundo. Resultados. En cuanto a fiabilidad, el Delfia Xpress mostró una imprecisión intra-interdía en las determinaciones de fβhCG y PAPP-A inferiores al 6%, comprobándose la linealidad y la correlación de sus determinaciones. El análisis de los resultados de 3.020 gestantes del cribado prenatal combinado del primer trimestre muestra una sensibilidad en la detección del síndrome de Down de 78,57% y un valor predictivo positivo (VPP) de 11,58%, con un 2,79% de falsos positivos. Se diagnosticaron 11 portadoras de síndrome de Down y 2 de síndrome de Edwards. Respecto a la practicabilidad, su sencillo manejo y puesta en marcha, y la estabilidad de las calibraciones, junto con el coste equitativo por cribado, hacen que el analizador presente una buena relación calidad/coste. Conclusiones. El completo estudio realizado muestra que el Delfia Xpress es un analizador de elevada fiabilidad técnica y clínica, y los resultados hallados lo validan para procesar la rutina del cribado prenatal en nuestro hospital de referencia (AU)
Objective. To evaluate the Delfia Xpress analyzer reliability and practicability in all the techniques of first and second trimester prenatal screening. Materials and methods. The Delfia Xpress (Perkin-Elmer, Wallac) is a biochemical immunoassay analyzer,that uses the Europium as specific fluorescent labelled marker and allows the determination of the first and second trimester parameters of the prenatal screening profile's: free β-human chorionic gonadotrophin (fβhCG) and pregnancy associated plasma protein-A (PAPP-A), alpha-fetoprotein (AFP), free-estriol (uE3), incorporating the Lifecycle v3.0® software for risk-prenatal calculation on-line with the laboratory compute system. First trimester combined screening test was performed on 3020 pregnant women and 678 on second trimester screening tests. Results. Concerning its reliability, Delfia Xpress analyzer has shown a within and between day imprecision for the fβhCG and PAPP-A determinations below to 6%, proving the linearity and the correlation of its determinations. The analysis of the results of 3020 first trimester combined prenatal screening tests, shows a sensitivity in detecting Downs syndrome of 78.57% with a PPV (positive predictive value) of 11.58% with a 2.79% false positive. Eleven patients were diagnosed as carriers of Downs syndrome and two with Edwards syndrome. As for the practicability, the start up and operation of the analyzer are simple, and the stability of the calibration along with equitable cost for screening, makes the Delfia Xpress as an analyzer with a good relationships quality/cost. Conclusions. The complete study has shown that Delfia Xpress is an analyzer with a high technical and clinical reliability, validating the instrument for processing the prenatal screening routine of our reference hospital (AU)
Subject(s)
Humans , Male , Female , Mass Screening/methods , Neonatal Screening/methods , Aneuploidy , Down Syndrome/diagnosis , Chorionic Gonadotropin , Prenatal Diagnosis/methods , Biomarkers/analysis , Biomarkers/metabolism , Trisomy/diagnosis , Trisomy/genetics , Confidence Intervals , False Negative Reactions , Calibration , Mass Screening/analysis , Amniocentesis/instrumentation , Amniocentesis/methodsABSTRACT
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