Pregnant women seem to be at risk for developing complications from COVID-19. Given the limited knowledge about the impact of COVID-19 on pregnancy, management guidelines are fundamental. Our aim was to examine the obstetrics guidelines released from December 2019 to April 2020 to compare their recommendations and to assess how useful they could be to maternal health workers. We reviewed 11 guidelines on obstetrics management, assessing four domains: (1) timeliness: the time between the declaration of pandemics by WHO and a guideline release and update; (2) accessibility: the readiness to access a guideline by searching it on a common browser; (3) completeness: the amount of foundational topics covered; and (4) consistency: the agreement among different guidelines. In terms of timeliness, the Royal College of Obstetricians and Gynaecologists (RCOG) was the first organization to release their recommendation. Only four guidelines were accessible with one click, while only 6/11 guidelines covered more than 80% of the 30 foundational topics we identified. For consistency, the study highlights the existence of 10 points of conflict among the recommendations. The present research revealed a lack of uniformity and consistency, resulting in potentially challenging decisions for healthcare providers.
Background. Gestational diabetes mellitus (GDM) is diabetes first diagnosed in pregnancy. GDM, together with its short- and long-term negative outcomes, is increasing in incidence all over the world. The current diagnostic method for GDM, the oral glucose tolerance test (OGTT), is dated and has been reported as inconvenient for women as well as poorly reproducible and reliable. Aims. We aimed at assessing the acceptability, feasibility, and accuracy of continuous glucose monitoring (CGM) as a diagnostic test for GDM and explore its correlation with the OGTT and risk factors for GDM. Methods. In this prospective cohort study, pregnant women due for or having completed OGTT underwent CGM for seven days, performing daily finger-prick blood glucose levels before completing an acceptability questionnaire. Data on GDM risk factors and CGM variability were analyzed and compared with OGTT results. Results. Seventy-three women completed CGM (40 GDM, 33 normal glucose tolerances); 34 concurrently underwent OGTT. CGM was acceptable and generally well-tolerated, with skin irritation/itchiness the only adverse event (11 mild, one severe). CGM and OGTT strongly correlated for fasting glucose values ( r = 0.86 , p < 0.05 ) only. Triangulating GDM risk factors, OGTT results and CGM variability parameters with the application of machine learning highlighted the possibility of unmasking false positive (11 showed low CGM variability and demographic risks but positive OGTT) and false-negative OGTT diagnoses (1 showed high CGM variability and demographic risks but negative OGTT). Conclusions. CGM was well-tolerated, showing poorer glycaemic control in GDM, and revealing potential misdiagnosis of the OGTT when combined with GDM risk factors. Future research is needed to determine cut-off values for CGM-defined and OGTT-independent screening criteria for GDM.
Background Established risk factors for Gestational Diabetes Mellitus (GDM) include age, ethnicity, family history of diabetes and previous GDM. Additional significant influences have recently been demonstrated in the literature. The oral glucose tolerance test (OGTT) used for GDM diagnosis has sub-optimal sensitivity and specificity, thus often results in GDM misdiagnoses. Comprehensive screening of risk factors may allow more targeted monitoring and more accurate diagnoses, preventing the devastating consequences of untreated or misdiagnosed GDM. We aimed to develop a comprehensive online questionnaire of GDM risk factors and triangulate it with the OGTT and continuous glucose monitoring (CGM) parameters to better evaluate GDM risk and diagnosis. Methods Pregnant women participating in two studies on the use of CGM for GDM were invited to complete the online questionnaire. A risk score, based on published literature, was calculated for each participant response and compared with the OGTT result. A total risk score (TRS) was then calculated as a normalised sum of all risk factors. Triangulation of OGTT, TRS and CGM score of variability (CGMSV) was analysed to expand evaluation of OGTT results. Results Fifty one women completed the questionnaire; 29 were identified as ‘high-risk’ for GDM. High-risk ethnic background (p < 0.01), advanced age, a family diabetic history (p < 0.05) were associated with a positive OGTT result. The triangulation analysis (n = 45) revealed six (13%) probable misdiagnoses (both TRS and CGMSV discordant with OGTT), consisting of one probable false positive and five probable false negative by OGTT results. Conclusions This study identified pregnant women at high risk of developing GDM based on an extended evaluation of risk factors. Triangulation of TRS, OGTT and CGMSV suggested potential misdiagnoses of the OGTT. Future studies to explore the correlation between TRS, CGMSV and pregnancy outcomes as well as additional GDM pregnancy biomarkers and outcomes to efficiently evaluate OGTT results are needed.
Background Gestational diabetes mellitus (GDM) is glucose intolerance first recognised during pregnancy. Both modalities and thresholds of the GDM diagnostic test, the Oral Glucose Tolerance Test (OGTT), have varied widely over time and among countries. Additionally, OGTT limitations include inconsistency, poor patient tolerability, and questionable diagnostic reliability. Many biological parameters have been reported to be modified by GDM and could potentially be used as diagnostic indicators. This study aimed to 1) systematically explore biomarkers reported in the literature as differentiating GDM from healthy pregnancies 2) screen those indicators assessed against OGTT to propose OGTT alternatives. Main body A systematic review of GDM diagnostic indicators was performed according to PRISMA guidelines (PROSPERO registration CRD42020145499). Inclusion criteria were full-text, comprehensible English-language articles published January 2009-January 2021, where a biomarker (from blood, ultrasound, amniotic fluid, placenta) was compared between GDM and normal glucose tolerance (NGT) women from the second trimester onward to immediately postpartum. GDM diagnostic method had to be clearly specified, and the number of patients per study higher than 30 in total or 15 per group. Results were synthesised by biomarkers. Results Of 13,133 studies identified in initial screening, 174 studies (135,801 participants) were included. One hundred and twenty-nine studies described blood analytes, one amniotic fluid analytes, 27 ultrasound features, 17 post-natal features. Among the biomarkers evaluated in exploratory studies, Adiponectin, AFABP, Betatrophin, CRP, Cystatin-C, Delta-Neutrophil Index, GGT, TNF-A were those demonstrating statistically and clinically significant differences in substantial cohorts of patients (> 500). Regarding biomarkers assessed versus OGTT (i.e. potential OGTT alternatives) most promising were Leptin > 48.5 ng/ml, Ficolin3/adiponectin ratio ≥ 1.06, Chemerin/FABP > 0.71, and Ultrasound Gestational Diabetes Score > 4. These all demonstrated sensitivity and specificity > 80% in adequate sample sizes (> / = 100). Conclusions Numerous biomarkers may differentiate GDM from normoglycaemic pregnancy. Given the limitations of the OGTT and the lack of a gold standard for GDM diagnosis, advanced phase studies are needed to triangulate the most promising biomarkers. Further studies are also recommended to assess the sensitivity and specificity of promising biomarkers not yet assessed against OGTT. Trial registration PROSPERO registration number CRD42020145499.
Background Gestational Diabetes Mellitus (GDM) incidence and adverse outcomes have increased globally. The validity of the oral glucose tolerance test (OGTT) for GDM diagnosis has long been questioned, with no suitable substitute reported yet. Continuous Glucose Monitoring (CGM) is potentially a more acceptable and comprehensive test. The aim of this study was to assess the Freestyle Libre Pro 2 acceptability as a diagnostic test for GDM, then triangulating its results with OGTT results as well as risk factors and sonographic features of GDM. Methods Women wore the CGM device for 7 days at 24–28 weeks, undergoing the OGTT before CGM removal. CGM/OGTT acceptability as well as GDM risk factors evaluation occurred via three online surveys. CGM distribution/variability/time in range parameters, combined in a CGM Score of Variability (CGMSV), were triangulated with OGTT results and a risk-factor-based Total Risk Score (TRS). In a subgroup, GDM ultrasound features (as modified Ultrasound Gestational Diabetes Score – m-UGDS) were also incorporated. Results Of 107 women recruited, 87 (81%) were included: 74 (85%) with negative OGTT (NGT) and 13 (15%) positive (GDM). No significant difference was found between NGT and GDM in terms of demographics (apart from family history of diabetes mellitus), CGM parameters and perinatal outcomes. Women considered CGM significantly more acceptable than OGTT (81% versus 27% rating 5/5, p < 0.001). Of the 55 NGT with triangulation data, 28 were considered ‘true negative’ (TRS concordant with OGTT and CGMSV): of these 4/5 evaluated at ultrasound had m-UGDS below the cut-off. Five women were considered ‘false negative’ (negative OGTT with both TRS and CGMSV above the respective cut-offs). Triangulation identified also six ‘false positive’ women (positive OGTT but TRS and CGM both below the cut-offs). Only one woman for each of the last two categories had m-UGDS evaluated, with discordant results. Conclusions CGM represents a more acceptable alternative for GDM diagnosis to the OGTT. CGM triangulation analysis suggests OGTT screening may result in both false positives and negatives. Further research including larger cohorts of patients, and additional triangulation elements (such as GDM biomarkers/outcomes and expanded m-UGDS) is needed to explore CGM potential for GDM diagnosis.
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