Placental growth factor level is correlated with intrapartum fetal heart rate findings.

OBJECTIVE: Here, we tested the correlation between maternal placental growth factor (PlGF) and fetal heart rate (FHR) monitoring findings. METHODS: We included 35 women with single pregnancies from 35 to 42 weeks of gestation who were hospitalized owing to onset of labor. Blood samples were collected at the start of labor. Intrapartum FHR monitoring parameters included total deceleration area, average deceleration area (mean deceleration area per 10 min), and five-tier classification level. RESULTS: Of the 35 women, 26 (74%) had vaginal delivery and 9 (26%) had cesarean section. After excluding 2 women who had cesarean section for arrest of labor, we analyzed 26 women who had vaginal delivery (VD group) and 7 who had cesarean section for fetal indications (CSF group). PlGF level was significantly higher in the VD group (157 ± 106 pg/ml) than in the CSF group (74 ± 62 pg/ml) (P = 0.03). There were no significant correlations between PlGF and total (r = -0.07) or average (r = -0.08) deceleration area.　There was a significant negative correlation (r = -0.42, P = 0.01) between PlGF and the percentage of level 3 or higher in the five-level classification. CONCLUSION: PlGF was correlated with FHR monitoring findings and might be a promising biomarker of intrapartum fetal function.

Inter-observer reliability of 4 fetal heart rate classifications.

OBJECTIVE: Different classification of fetal heart rate (FHR) pattern have been proposed: FHR classified as either "reassuring" or "non-reassuring", the National Institute of Child Health and Human Development (NICHD) published in 2008 a 3-tier system, the French College of Gynecology and Obstetrics (CNGOF) recommended in 2013 a 5-tier system and recently in 2015, the Federation International of Gynecology and Obstetrics (FIGO) proposed a new classification based on a 3-tier system. Our objective was to assess the inter-observer reliability of these 4 existing classifications. STUDY DESIGN: Four observers reviewed 100 FHR without clinical information. FHR were obtained from term singleton pregnancies. Fetal heart rate patterns were classified by one 2-tier ("reassuring vs. non-reassuring"), two 3-tier (NICHD 2008 and FIGO 2015), and one 5-tier (CNGOF 2013) fetal heart classifications. RESULTS: The global agreement between observers was moderate for each classification: 0.58 (0.40-0.74) for the 2-tier, 0.48 (0.37-0.58) for the NICHD 2008, 0.58 (0.53-0.63) for the CNGOF 2013 and 0.59 (0.49-0.67) for the FIGO 2015 classification. When FHR was classified as reassuring, it was classified as normal in 85.5% for the NICHD 2008 and in 94.5% for the FIGO 2015. For the CNGOF 2013, 65.0% were classified as normal and 32.5% as quasi normal. There was strong concordance between FIGO category I and "reassuring" FHR (kappa=0.95). CONCLUSION: Inter-observer agreement of FHR interpretation is moderate whatever the classification used. To evaluate the superior interest of one classification, it will be interesting to compare their impact on need of second line techniques and on neonatal outcome.

Comparison of five classification systems for interpreting electronic fetal monitoring in predicting neonatal status at birth.

OBJECTIVE: To compare the accuracy of five different classification systems for interpreting electronic fetal monitoring (EFM) when predicting neonatal status at birth, as determined by the umbilical cord arterial pH. METHODS: Ninety-seven cardiotocography traces were retrospectively interpreted according to five classification systems for EFM: Dublin Fetal Heart Rate Monitoring Trial (DFHRMT), Royal College of Obstetricians and Gynecologists (RCOG), Society of Obstetricians and Gynaecologists of Canada (SOGC), National Institute of Child Health and Human Development (NICHD) and Parer & Ikeda's. For each classification system, sensitivity, specificity, positive and negative predictive values were calculated. The capacity of the classifications to predict neonatal pH was also evaluated by receiver-operating characteristic (ROC) curves. Agreement between the five systems was estimated using weighted kappa statistic. RESULTS: Considering pH ≤7.15 as the cutoff for low pH, the sensitivity and specificity values were 100 and 18% (DFHRMT); 100 and 15% (RCOG); 88 and 37% (SOGC); 67 and 92% (NICHD); 55 and 67% (Parer & Ikeda). The ROC curves showed that all classifications analyzed had a low discriminative capacity when predicting umbilical artery pH ≤7.15. An excellent agreement was observed between DFHRMT and RCOG (weighted κ value: 0.860). CONCLUSIONS: Parer & Ikeda and NICHD classifications had the highest specificity in detecting umbilical cord arterial pH ≤7.15. The high specificity of the NICHD classification is hindered by a high percentage of "intermediate" traces (80%). Parer & Ikeda classification is the one that best classify as pathological only the traces of fetuses that are truly at risk of acidemia, thus avoiding unnecessary intervention. It also showed the best trade-off between sensitivity and specificity and the lowest rate of traces considered "intermediate."

Variable decelerations: do size and shape matter?

OBJECTIVE: To determine the ability of variable decelerations and 8 subtypes, defined by size and shape, to discriminate tracings between babies with normal umbilical artery gases (N) and those with metabolic acidemia (MA). METHODS: Tracings from the last 4 hours from N-3320 babies with base deficit levels under 8 mmol/L, and from MA-316 babies with base deficits over 12 mmol/L were analyzed using computerized pattern recognition. We created receiver operating characteristic curves and area under the curves (AUCs) for each deceleration subtype. RESULTS: Only 3 subtypes showed significant discrimination: those with a prolonged duration (AUC 0.6109 P < 0.0001), loss of internal variability (AUC 0.5694 P < 0.0001) or with "sixties" criteria (AUC 0.5997 P < 0.0001). A variable deceleration met the sixties criteria if two or more of the following were present: depth was 60 bpm or more, lowest value was 60 or less, duration was 60 seconds or longer. All other subtypes were no better than chance. CONCLUSIONS: Finer gradation within the middle category of electronic fetal monitoring classification is needed because most tracings, including those from babies with MA, will be located in the Category II. This analysis identifies which variable decelerations have a significant association with MA and which do not.

Medical devices; obstetrical and gynecological devices; classification of computerized labor monitoring system. Final rule.

The Food and Drug Administration (FDA) is classifying the computerized labor monitoring systems into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems," which will serve as the special controls for these devices. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices.

Medical devices; effective date of requirement for premarket approval for a class III preamendments obstetrical and gynecological device. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of product development protocol (PDP) for a Group 1 preamendments class III device, the obstetric data analyzer intended to analyze data from fetal and maternal monitors during labor and to warn of possible fetal distress. The agency has summarized its findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the devices.

Monitorización antenatal rutinaria en gestantes de bajo riesgo obstétrico / Routine monitoring of low obstetric risk gestants

Nuestro objetivo fue evaluar el beneficio y el momento de inicio del test no estresante en los embarazos de bajo riesgo obstétrico de nuestro medio. Estudio retrospectivo de 100 gestaciones sin enfermedad asociada procedentes de nuestras consultas externas. Se evaluaron los siguientes parámetros: edad materna, paridad, test no estresante (TNS) semanal desde la semana 38 hasta el momento del parto, recuento de movimientos fetales, prueba de Pose cuando fue necesaria, monitorización intraparto, estudio bioquímico fetal cuando fue preciso, tipo de parto, peso del recién nacido (RN) y test de Apgar al primer y quinto minutos. Se realizó un estudio descriptivo de todas las variables y se compararon los resultados del último TNS con el test de Apgar del RN. Se consideraron significativos los valores de p < 0,05. Sólo se registró un 1 por ciento de TNS patológicos y se trataba de una gestación de 41 semanas. Ningún test de Apgar fue inferior a 8 a los 5 min. En nuestro medio, la monitorización fetal no estresante resulta innecesaria en embarazos de bajo riesgo obstétrico antes de la 40 semana de gestación, ya que no aporta beneficios en la valoración del estado del bienestar fetal (AU)

Uterine EMG analysis: a dynamic approach for change detection and classification.

Toward the goal of detecting preterm birth by characterizing events in the uterine electromyogram (EMG), we propose a method of detection and classification of events in this signal. Uterine EMG is considered as a nonstationary signal and our approach consists of assuming piecewise stationarity and using a dynamic change detector with no a priori knowledge of the parameters of the hypotheses on the process state to be detected. The detection approach is based on the dynamic cumulative sum (DCS) of the local generalized likelihood ratios associated with a multiscale decomposition using wavelet transform. This combination of DCS and multiscale decomposition was shown to be very efficient for detection of both frequency and energy changes. An unsupervised classification based on the comparison between variance-covariance matrices computed from selected scales of the decomposition was implemented after detection. Finally a class labeling based on neural networks was developed. This algorithm of detection-classification-labeling gives satisfactory results on uterine EMG: in most cases more than 80% of the events are correctly detected and classified whatever the term of gestation.

Perfil biofisico fetal: analise critica / Fetal biophysical profile: critical analysis

Analisou-se o resultado perinatal de 307 gestacoes consideradas de risco elevado, cujos fetos foram avaliados atraves de perfil biofisico fetal (PBF), e cujo ultimo exame ocorreu em prazo menor ou igual a 7 dias do parto. Utilizou-se PBF com 6 variaveis: cardiotocografia, quantidade de liquido amniotico, textura ultrassonografica da placenta, movimentacao fetal, movimentacao respiratoria fetal e tonus muscular fetal, sendo as ultimas cinco analisadas pela ultrassonografia...

The nonstress test.

Antepartum fetal evaluation by heart rate monitoring was carried out on a clinical service during a 1-year period utilizing the nonstress test as the primary screening device. Nonreactive nonstress tests were supplemented by the oxytocin contraction stress test. In this study, the use of the nonstress test appropriately led to the identification of all fetuses who were in jeopardy and, in the majority of instances, identified fetuses in good condition who did not require the administration of oxytocin to determine fetal well-being. In our experience, the nonstress test is a reliable, inexpensive, convenient, time-saving screening procedure which can be made available to a greater number of patients than the contraction stress test alone.