Comparison between trans-vaginal and trans-abdominal ultrasound examination of the cervix in the second trimester of pregnancy: a prospective study.

OBJECTIVES: To compare transvaginal (TV) and trans-abdominal (TA) ultrasound assessment of cervical length (CL) at the time of the second-trimester scan for fetal anomalies. METHODS: This was a prospective study including consecutive pregnant women attending the low-risk ultrasound clinic of two fetal medicine centres in Italy. The inclusion criteria were women between 19 + 0 and 22 + 0 weeks of gestation, attending the prenatal ultrasound clinic for the routine second trimester screening for fetal anomalies. The primary outcome was to compare the CL measurement obtained at TV compared to TA ultrasound; the secondary outcome was to report the inter and intra-observer variability of CL measured with the two different approaches. All women underwent TV and TA assessment of the cervix performed by two experienced certified operators, blinded to each other. Intra-class correlation coefficients (ICC) and Bland-Altman analyses were used to analyse the data. RESULTS: Two hundred and fifty women were included in the analysis. All women had anteverted uterus. The mean gestational age at ultrasound was 20.7 ± 0.7 weeks; 1.2 % (3/250) scans were performed at 19 weeks, 49.2 % (123/250) at 20 weeks, 44.8 % (112/250) at 21 weeks and 4.8 % (12/250) at 22 weeks of gestations. Identification of the major landmarks of CL at TA ultrasound was achieved in all the included cases. There was good reliability between CL measured at TA (ICC 0.95, 95 % CI 0.93-0.97 for observer 1 and 0.92 %, 95 % CI 0.89-0.94 for observer 2) and TV ultrasound 0.97, 95 % CI 0.96-0.98 for observer 1 and 0.96, 95 % CI 0.95-0.97 for observer 2). There was also good reliability between the two observers for both the TA and TV assessment of the CL. Mean TA CL was 41.4 ± 5.5 for observer 1 and 40.5 ± 4.8 for observer 2 with no significant differences between the two measurements (mean difference 0.92 mm, 95 % CI -9.7 to 11.2). Likewise, there was no difference between the CL measured at TV ultrasound between the two observers (mean difference -0.83 mm, 95 % CI -5.97 to 4.30). Finally, there was no difference in the mean CL measured at TA compared to TV, either considering the overall population of women (mean difference: -0.43, 955 CI -8.65 to 7.79), or when stratifying the analysis according to the parity status and the operator. CONCLUSIONS: Among experienced operators, there was no difference between TV and TA ultrasound assessment of the CL at the time of the routine anomaly scan for fetal anomaly.

Validation of an automated software (Smartpelvic™) in assessing hiatal area from three dimensional transperineal pelvic volumes of pregnant women: comparison with manual analysis.

OBJECTIVES: The aim of this investigation was to evaluate the agreement between a manual and an automatic technique in assessing levator hiatus area (LHA) during pregnancy from three-dimensional (3D) pelvic floor volumes obtained by trans-perineal ultrasound (TPUS). METHODS: 3D volumes were acquired during rest, maximum pelvic floor contraction and Valsalva maneuver from 66 pregnant women. Manual selection of LHA and automatic software (Smart Pelvic™) were applied on TPUS volume starting from a C-plane view. To evaluate intra- and inter-observer variability measurements of LHA were performed twice by the same operator and once by a second sonographer. Reference hiatal contours obtained manually by the first operator were compared with the automated ones. Reproducibility was evaluated by intraclass correlation coefficients (ICC) and Bland-Altman plots. RESULTS: LHA measurement, using automatic software, achieved excellent intra-observer and inter-observer reproducibility in pregnant women both at rest and after dynamic analysis (ICC>0.9). Further, an excellent agreement resulted between manual selection of the LHA and automatic imaging (ICC>0.9). The average time taken to obtain LHA manually was significantly longer when compared to the automatic analysis (p≤0.0001). CONCLUSIONS: Smart pelvic software resulted from a reliable method for automatically measuring the LHA, showing high reproducibility and accuracy.

Cervical length as a screening tool for preterm birth in twin pregnancies: a systematic review and critical evaluation of quality clinical practice guidelines.

OBJECTIVES: Twin pregnancies are at increased risk of preterm birth (PTB) compared to singletons. Evaluation of cervical length (CL) represents the optimal tool to screen PTB in singleton. Conversely, there is less evidence on the use of CL in twins. Our aim was to evaluate the methodological quality and clinical heterogeneity of clinical practice guidelines (CPGs) on the CL application in twins using AGREE II methodology. METHODS: MEDLINE, Scopus, and websites of the main scientific societies were examined. The following aspects were evaluated: diagnostic accuracy of CL, optimal gestational age at assessment and interventions in twin pregnancies with reduced CL. The quality of the published CPGs was carried out using "The Appraisal of Guidelines for REsearch and Evaluation (AGREE II)" tool. The quality of guideline was rated using a scoring system. Each considered item was evaluated by the reviewers on a seven-point scale that ranges from 1 (strongly disagree) to 7 (strongly agree). A cut-off >60 % identifies a CPGs as recommended. RESULTS: The AGREE II standardized domain scores for the first overall assessment had a mean of 74 %. The score was more than 60 % in the 66.6 % of CPGs analyzed indicating an agreement between the reviewers on recommending the use of these CPGs. A significant heterogeneity was found; there was no specific recommendation on CL assessment in about half of the published CPGs. There was also significant heterogeneity on the CL cut-off to prompt intervention. CONCLUSIONS: Despite the fact that the AGREE II analysis showed that the majority of the included guidelines are of good quality, there was a significant heterogeneity among CPGs as regard as the indication, timing, and cut-off of CL in twins as well as in the indication of interventions.

Prognostic Value of Amniotic Fluid Viral Load to Predict Adverse Outcome in Pregnancies Complicated by Congenital Cytomegalovirus Infection: A Multicenter Study.

INTRODUCTION: The aim of the study was to report the prognostic value of cytomegalovirus (CMV) viral load in the amniotic fluid (AF) in predicting the outcome of infected pregnancies. METHODS: Multicenter retrospective study involving 11 Italian referral centers from 2012 to 2021 was conducted. Inclusion criteria were fetuses with confirmed congenital CMV infection. The primary outcome was the prognostic value accuracy of CMV quantitative polymerase chain reaction (qPCR) in AF in predicting the risk of additional anomalies detected either at follow-up ultrasound or fetal magnetic resonance imaging (MRI). The secondary outcome was prediction of postnatal clinical symptoms related to CMV infection. Multivariate logistic regression and area under the curve (AUC) analyses were used to analyze the data. RESULTS: 104 fetuses were included. Associated anomalies detected at follow-up ultrasound or fetal MRI were detected in 14.4% of cases (15/104). Mean AF CMV viral load was significantly higher in fetuses with additional anomalies compared to those without additional anomalies at follow-up ultrasound or fetal MRI (3,346,634.27 ± 402,582.95 vs. 761,934 ± 222513,2 p < 0.001). At multivariate logistic regression analysis, CMV AF viral load was independently associated with the presence of additional anomalies at follow-up ultrasound or MRI, with an OR of 1.07 (p = 0.010), while maternal age (p = 0.24), trimester at maternal infection (p = 0.97), and type of infection (primary vs. non-primary) (p = 0.12) were not. CMV AF viral load had AUC of 0.755 for the occurrence of anomalies due to CMV infection, with an optimal cut-off point of >1,310,520 copies/mL, a sensitivity of 66.7%, a specificity of 84.3%, and a positive likelihood ratio of 4.24. Once excluding fetuses with anomalies at ultrasound or MRI, the diagnostic performance of qPCR in identifying fetuses with symptomatic infection after birth was low, with an AUC of 0.586. CONCLUSION: CMV viral load at second trimester amniocentesis has a moderate accuracy for the occurrence of CMV-related anomalies in fetuses with congenital infection and normal ultrasound at the initial diagnosis. Conversely, prediction of symptomatic infection is low.

Prenatal predictors of adverse perinatal outcome in congenital cytomegalovirus infection: a retrospective multicenter study.

OBJECTIVES: To identify predictors of adverse perinatal outcome in congenital cytomegalovirus (CMV) infection. METHODS: In a multicenter study fetuses with congenital CMV infection diagnosed by PCR on amniotic fluid and normal prenatal imaging at the time of diagnosis were included. Primary outcome was the occurrence of structural anomalies at follow-up ultrasound or prenatal magnetic resonance imaging (MRI). Secondary outcomes were the occurrence of anomalies detected exclusively postnatally and the rate of symptomatic infection. RESULTS: One hundred and four fetuses with congenital CMV were included in the study. Anomalies were detected at follow-up ultrasound or MRI in 18.3% (19/104) cases. Additional anomalies were found after birth in 11.9% (10/84) of cases and 15.5% (13/85) of newborns showed clinical symptoms related to CMV infection. There was no difference in either maternal age (p=0.3), trimester (p=0.4) of infection and prenatal therapy (p=0.4) between fetuses with or whiteout anomalies at follow-up. Conversely, median viral load in the amniotic fluid was higher in fetuses with additional anomalies at follow-up (p=0.02) compared to those without. At multivariate logistic regression analysis, high viral load in the amniotic fluid, defined as ≥100,000 copies/mL was the only independent predictor for the occurrence of anomalies detected exclusively at follow-up ultrasound assessment or MRI, with an OR of 3.12. CONCLUSIONS: Viral load in the amniotic fluid is a strong predictor of adverse perinatal outcome in congenital CMV infection. The results of this study emphasize the importance of adequate follow up even in case of negative neurosonography to better predict postnatal adverse outcomes of infected newborns, especially in amniotic fluid high viral load.

Fetal brain biometry and cortical development in congenital heart disease: A prospective cross sectional study.

OBJECTIVE: To evaluate brain biometry and cortical development by neurosonography in fetuses with congenital heart defect (CHD) and evaluate differences among different type of CHD. METHODS: In a prospective cross sectional study singleton fetus with CHD were matched with controls and grouped into two categories according to the predicted severity of cerebral arterial oxygen deficit induced by the CHD: Group A mildly reduced or normal and Group B moderately to severely reduced. Neurosonography was done at 30-33 weeks to obtain measurements of corpus callosum (CC), cerebellar vermis (CV), Sylvian fissure (SF) insula, parieto-occipital fissure (POF), and calcarine sulci fissures (CSF). All the neurosonographic parameters were adjusted by head circumference (HC). RESULTS: A total of 78 fetuses with CHD (group A 30; group B 48) and 80 matched controls form uncomplicated pregnancies were considered. CHD fetuses have significantly smaller CC, CV, SF, and POF and bigger insula when compared to control fetuses. These differences are more marked in group B fetuses. These differences remained significant after correction for HC values. CONCLUSION: Fetuses with CHD have an impaired cortical development and these variations are more evident in those with a predicted lower oxygen delivery to the brain.

Systematic Review and Critical Evaluation of Quality of Clinical Practice Guidelines on Nutrition in Pregnancy.

Objective: To report the quality and clinical heterogeneity of the published clinical practice guidelines (CPGs) on nutrition in pregnancy. Methods: MEDLINE, Embase, Scopus, and ISI Web of Science databases were searched. The following aspects related to nutrition in pregnancy were addressed: specific requirements during pregnancy, description of a balanced diet, weight gain, prevention of food-borne, nutrition in peculiar sub-groups of women, and maternal or perinatal outcomes. The assessment of the risk of bias and quality assessment of the included CPGs were performed using "The Appraisal of Guidelines for REsearch and Evaluation (AGREE II)" tool divided in six quality domains: scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, editorial independence. Mean ± standard deviation (SD) was used to summarize the scores across all the guidelines per domain. The quality of each guideline was computed using the scoring system proposed by Amer et al. A cut-off of >60% was sued to define a CGP as recommended. Results: Eighteen CPGs were included. There was a substantial heterogeneity in the recommended dose for vitamins, folic acid, and micronutrient intake during pregnancy among the different published CPGs. 27.8% (5/18) of the CPGs recommended a daily intake of folic acid of 200 mcg, 38.8% (7/18) 400 mcg, 16.7% (3/18) 600 mcg while the remaining CPGs suggested dose between 400 and 600−800 mc per day. Adequate maternal hydration was advocated in the large majority of included CPGs, but a specific amount of water intake was not reported in 83.3% (15/18) cases. There was also significant heterogeneity in various other aspects of nutrition recommendation among the different CPGs, including gestational weight gain (55.5%), prevention of food-borne diseases in pregnancy (72.2%), nutrition in particular groups of pregnant women (83.3%), maternal and perinatal outcomes (72.2%). The AGREE II standardized domain scores for the first overall assessment (OA1) had a mean of 65% but only half scored more than 60%. Conclusion: The published CPGs on nutrition in pregnancy show an overall good methodology, but also a substantial heterogeneity as regard as different major aspects on nutrition in pregnancy.

Trauma in pregnancy clinical practice guidelines: systematic review.

PURPOSE: To objectively evaluate the methodological quality and clinical heterogeneity robustness of the published clinical practice guidelines (CPGs) on the management of trauma in pregnancy. MATERIALS AND METHODS: Pubmed, Google Scholar, UpToDate, and Scopus Database were searched. The risk of bias and quality assessment of the included CPGs were performed using "The Appraisal Of Guidelines for Research and Evaluation (AGREE II)" tool. The following points relating to the management of trauma during pregnancy were addressed: quality of evidence assessment, classification of recommendations, main causes of trauma in pregnancy, importance of correct use of seat belts, ultrasound scans and/or pregnancy test in every female of reproductive age, description of physiological changes in pregnancy, classification in primary and secondary survey, primary survey based on ABCD Approach, fetus viable based on the weeks, radiographic studies for maternal evaluation, duration of fetal monitoring, use of anti-D immunoglobulin in rhesus-D-negative pregnant trauma patients, description of dose of RhD-Ig, the way to define gestational age if it was undetermined, descriptions of obstetrical complications, use of tetanus vaccination, and timing to perimortem cesarean section (CS). RESULTS: Six CPGs were included. Quality of evidence assessment was described in 16.7% of CPGs (1/6), while it was not reported in 83.3% (5/6). Classification of recommendations was reported in 50% (3/3) of the CPGs. Motor vehicle crash was reported as the main cause of trauma in pregnancy in all the CPGs included in the present review, despite that the importance of a correct use of seat belts was described only in the 50% (3/6). Definition of fetal viability was also different among the included CPGs; in 50% (3/6) defined a fetus viable when it from 23 weeks, 33.3% (2/6) from 24 weeks, and 16.7% (1/6) from 20 weeks of gestation. Regarding the type of fetal monitoring, 33.3% (2/6) CPGs recommended CTG assessment at least every 4 h, 16.7% (1/6) at least every 6 h, 33.3% for 24 h if there are not reassuring signs and 16.7% (1/6) did not specify the duration of monitoring. Recommendations about the use of anti-D-immunoglobulin in rhesus-D-negative pregnant were also heterogeneous: 50% (3/6) of the CPGs suggested administration in all rhesus-D-negative pregnant women, 16.7% (1/6) only according to gestational age at trauma or in case of significant abdominal trauma, and 16.7% (1/6) only in case of positive Kleihauer test while 16.7% (1/6) did not specify it. Administration of tetanus vaccination was suggested in in 33.3% (2/6) of CPGs. Finally, there were different descriptions of timing to perimortem CS: 33.3% (2/6) of CPGs claims to do CS no later than 4 min, 50% (3/6) no later than 5 min, and 16.7% (1/6) does not describe timing for CS. The AGREE II standardized domain scores for the first overall assessment (OA1) had a mean of 69%. Only three CPGs scored more than 60% and revealed a consensus agreement between the reviewers on recommending the use of these CPGs. CONCLUSION: There is clinical heterogeneity in some of the most relevant aspects of the management of pregnant women with trauma. The findings from this systematic review highlight the need for up to date and shared guidelines promoted by the main body societies in order make management of pregnant women with trauma homogenous.