Glucose circadian rhythm assessment in pregnant women for gestational diabetes screening.

BACKGROUND: Gestational diabetes mellitus (GDM) is the most common complication during pregnancy, and it is associated with short- and long-term health impairments. Even with increasing incidence rates worldwide, to date, GDM lacks an international standard diagnosis criterion. OBJECTIVE: To elucidate whether a chronobiological perspective may improve the identification of patients at risk for neonatal complications. METHODS: We analyzed a dataset with 92 recruited pregnant patients with Continuous Glucose Monitoring (CGM) data obtained in a blinded study. The primary outcome consisted in evaluating whether the composite of adverse neonatal outcomes could be predicted by chronobiological variables derived from fitting glucose oscillation to a circadian rhythm. The secondary neonatal outcomes included preterm birth, neonatal intensive care unit admission, hypoglycemia, mechanical ventilation or continuous positive airway pressure, hyperbilirubinemia, and hospital length of stay. The secondary maternal outcomes included weight gain during pregnancy, hypertensive disorders of pregnancy, induction of labor, cesarean delivery, and postpartum complications. 87 subjects had enough data to study for glucose circadian rhythmicity. RESULTS: We developed a 3-covariate model including two chronobiological metrics, the midline estimating statistic of rhythm (MESOR) and glucose M10 start-time, and age that was predictive of the primary outcome, and associated with maternal secondary outcomes (preeclampsia with severe features and weight gain during pregnancy), and newborn secondary outcomes (preterm delivery < 37 weeks, indicated preterm delivery, NICU admission, need for CPAP, and differences in length of hospital stay). CONCLUSIONS: Chronobiological parameters might contribute to a better identification of the adverse outcomes associated with GDM in both the mother and newborn.

Trends and Outcomes among Pregnancy and Nonpregnancy-Related Hospitalizations with Diabetic Ketoacidosis.

OBJECTIVE: The study's primary objective was to evaluate adverse outcomes among reproductive-age hospitalizations with diabetic ketoacidosis (DKA), comparing those that are pregnancy-related versus nonpregnancy-related and evaluating temporal trends. STUDY DESIGN: We conducted a retrospective cross-sectional study using the National Inpatient Sample to identify hospitalizations with DKA among reproductive-age women (15-49 years) in the United States (2016-2020). DKA in pregnancy hospitalizations was compared with DKA in nonpregnant hospitalizations. Adverse outcomes evaluated included mechanical ventilation, coma, seizures, renal failure, prolonged hospital stay, and in-hospital death. Multivariable Poisson regression models with robust error variance were used to estimate adjusted relative risk (aRR) and 95% confidence interval (CI). Annual percent change (APC) was used to calculate the change in DKA rate over time. RESULTS: Among 35,210,711 hospitalizations of reproductive-age women, 447,600 (1.2%) were hospitalized with DKA, and among them, 13,390 (3%) hospitalizations were pregnancy-related. The rate of nonpregnancy-related DKA hospitalizations increased over time (APC = 3.8%, 95% CI = 1.5-6.1). After multivariable adjustment, compared with pregnancy-related hospitalizations with DKA, the rates of mechanical ventilation (aRR = 1.56, 95% CI = 1.18-2.06), seizures (aRR = 2.26, 95% CI = 1.72-2.97), renal failure (aRR = 2.26, 95% CI = 2.05-2.50), coma (aRR = 2.53, 95% CI = 1.68-3.83), and in-hospital death (aRR = 2.38, 95% CI = 1.06-5.36) were higher among nonpregnancy-related hospitalizations with DKA. CONCLUSION: A nationally representative sample of hospitalizations indicates that over the 5-year period, the rate of nonpregnancy-related DKA hospitalizations increased among reproductive age women, and a higher risk of adverse outcomes was observed when compared with pregnancy-related DKA hospitalizations. KEY POINTS: · Over 5 years, the rate of pregnancy-related DKA hospitalizations was stable.. · Over 5 years, the rate of nonpregnancy-related DKA hospitalizations increased.. · There is a higher risk of adverse outcomes with DKA outside of pregnancy..

Large for Gestational Age and Adverse Outcomes: Stratified By Diabetes Status.

OBJECTIVE: To examine the association of adverse outcomes among parturients with large for gestational age (LGA; birth weight ≥ 90th) newborns, stratified by diabetes status. Additionally, we described the temporal trends of adverse outcomes among LGA neonates. STUDY DESIGN: This retrospective cohort study used the U.S. Vital Statistics dataset between 2014 and 2020. The inclusion criteria were singleton, nonanomalous LGA live births who labored and delivered at 24 to 41 weeks with known diabetes status. The coprimary outcomes were composite neonatal adverse outcomes of the following: Apgar score < 5 at 5 minutes, assisted ventilation > 6 hours, seizure, or neonatal or infant mortality, and maternal adverse outcomes of the following: maternal transfusion, ruptured uterus, unplanned hysterectomy, admission to intensive care unit, or unplanned procedure. Multivariable Poisson regression models were used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CI). Average annual percent change (AAPC) was calculated to assess changes in rates of LGA and morbidity over time. RESULTS: Of 27 million births in 7 years, 1,843,467 (6.8%) met the inclusion criteria. While 1,656,888 (89.9%) did not have diabetes, 186,579 (10.1%) were with diabetes. Composite neonatal adverse outcomes (aRR = 1.48, 95% CI = 1.43, 1.52) and composite maternal adverse outcomes (aRR = 1.37, 95% CI = 1.36, 1.38) were significantly higher among individuals with diabetes, compared with those without diabetes. From 2014 to 2020, the LGA rate was stable among people without diabetes. However, there was a downward trend of LGA in people with diabetes (AAPC = - 2.4, 95% CI = - 3.5, -1.4). CONCLUSION: In pregnancies with LGA newborns, composite neonatal and maternal morbidities were higher in those with diabetes, compared with those without diabetes. KEY POINTS: · Large for gestational age stratified by diabetes status.. · Composite neonatal and maternal adverse outcomes are worse among individuals with diabetes as compared to those without.. · During 2014 to 2020, the trend of LGA in individuals without diabetes increased..

Continuous glucose monitoring in individuals undergoing gestational diabetes screening.

BACKGROUND: Among guidelines on gestational diabetes mellitus, there is an incongruity about the threshold of maternal hyperglycemia to diagnose gestational diabetes mellitus. OBJECTIVE: This study aimed to ascertain the association between continuous glucose monitoring metrics and adverse outcomes among individuals undergoing gestational diabetes mellitus screening. STUDY DESIGN: This was a prospective study (from June 2020 to January 2022) of individuals who underwent 2-step gestational diabetes mellitus screening at ≤30 weeks of gestation. The participants wore a blinded continuous glucose monitoring device (Dexcom G6 Pro; Dexcom, Inc, San Diego, CA) for 10 days starting when they took the 50-g glucose challenge test. The primary outcome was a composite of adverse neonatal outcomes (large for gestational age, shoulder dystocia or neonatal injury, respiratory distress, need for intravenous glucose treatment for hypoglycemia, or fetal or neonatal death). The secondary neonatal outcomes included preterm birth, neonatal intensive care unit admission, hypoglycemia, mechanical ventilation or continuous positive airway pressure, hyperbilirubinemia, and hospital length of stay. The secondary maternal outcomes included weight gain during pregnancy, hypertensive disorders of pregnancy, induction of labor, cesarean delivery, and postpartum complications. Time within the target range (63-140 mg/dL), time above the target range (>140 mg/dL) expressed as a percentage of all continuous glucose monitoring readings, and mean glucose level were analyzed. The Youden index was used to choose the threshold of ≥10% for the time above the target range and association with adverse outcomes. RESULTS: Of 136 participants recruited, data were available from 92 individuals (67.6%). The 2-step method diagnosed gestational diabetes mellitus in 2 individuals (2.2%). Continuous glucose monitoring indicated that 17 individuals (18.5%) had time above the target range of ≥10%. Individuals with time above the target range of ≥10% had a significantly higher likelihood of composite adverse neonatal outcomes than individuals with time above the target range of <10% (63% vs 18%; P=.001). Furthermore, compared with neonates born to individuals with time above the target range of <10%, neonates born to individuals with time above the target range of ≥10% had an increased likelihood for hypoglycemia (14.5% vs 47%; P=.009) and had a longer length of stay (2 vs 4 days; P=.03). No difference in maternal outcomes was noted between the groups. CONCLUSION: In this prospective study of individuals undergoing gestational diabetes mellitus screening, a cutoff of the time above the target range of ≥10% using continuous glucose monitoring was associated with a higher rate of neonatal adverse outcomes. A randomized trial of continuous glucose monitoring vs 2-step screening for gestational diabetes mellitus to lower the rate of adverse outcomes is underway (identification number: NCT05430204).

Time to Completion of Two-Step Screening for Gestational Diabetes and Adverse Outcomes.

OBJECTIVE: This study aimed to ascertain whether the length of time to complete the gestational diabetes mellitus (GDM) screening was associated with adverse neonatal outcomes. STUDY DESIGN: This was a retrospective cohort study of singleton, nonanomalous individuals who were screened for GDM at ≥24 weeks' gestation at an academic hospital system. We compared outcomes among people who were diagnosed with GDM and completed the 3-hour glucose tolerance test (GTT) ≤14 second versus >14 days from the 1-hour glucose challenge test (GCT). The primary outcome was a composite adverse neonatal outcome of the following: large for gestational age, shoulder dystocia, birth injury, respiratory distress, hypoglycemia, or fetal/neonatal death. The secondary outcomes included several individual neonatal and maternal morbidities. Multivariable Poisson's regression models were used to evaluate the association. Adjusted relative risk (aRR) and 95% confidence intervals (CI) were calculated. RESULTS: Among the 313 individuals who completed the two-step screening for GDM and had an 1-hour GCT ≥ 135 mg/dL; of them, 171 (54.6%) completed the 3-hour GTT ≤14 days, 142 (45.4%) completed the 3-hour GTT > 14 days. Overall rate of the primary outcome was 44.1%. After multivariable adjustment, the risk of the primary outcome was similar between people who completed the two-step method in ≤14 versus >14 days (aRR = 1.11, 95% CI = 0.81-1.52). There was no significant difference in all secondary adverse outcomes between the two groups. Subgroup analyses, limited to people diagnosed with GDM (N = 89, 23.4%), also found similar results as the full analyses. CONCLUSION: Among individuals who completed the two-step screening for GDM, completion of the 3-hour GTT within ≤14 versus ≥ 14 days was not associated with an increase rate of the adverse outcomes. KEY POINTS: · Among pregnant people in an academic practice, 50% of people with abnormal 1-hour GTT completed GDM two-step screening in 14 days.. · Longer length of time to completion of diagnostic testing for GDM was not associated with an increased rate of adverse outcomes.. · Pregnant people that were diagnosed with GDM and completed the two-step method in >14 days did not have worse perinatal outcomes..

Spinal Hypotension and Time from Spinal-to-Delivery in Scheduled Cesarean Deliveries: Association with Neonatal Acidosis.

OBJECTIVE: This work aimed to study the effect of sustained hypotension after spinal on neonatal acidosis and adverse outcomes in those undergoing scheduled cesarean delivery (CD) with universal prophylactic vasopressor exposure and to examine differences in spinal-to-delivery time by neonatal acidosis status. STUDY DESIGN: This retrospective cohort study conducted at a quaternary care center from January 2019 to December 2021 included singleton, term, nonanomalous pregnancies, with scheduled CD under spinal anesthesia. Hypotension was defined as a systolic blood pressure (SYS-BP) < 100 mm Hg (SYS-BP100) or a >20% drop from baseline blood pressure (SYS-BP20). Both the occurrence of hypotension and its magnitude and duration were studied; the latter through the development of a hypotension index. The 90th and 95th percentiles of the hypotension index for SYS-BP20 and SYS-BP100, respectively, were used to define sustained hypotension. The primary outcome was neonatal acidosis (umbilical artery pH ≤ 7.1 or base excess ≤ -12 mmol). Secondary outcomes were composites of neonatal (CNAO) and maternal (CMAO) adverse outcomes. Multivariable Poisson regression models with robust error variance analysis was used to estimate adjusted relative risks (aRRs) and 95% confidence intervals (CIs). RESULTS: Our study included 332 individuals who underwent scheduled CD; among them 330 (99.4%) received prophylactic vasopressors. The rate of neonatal acidosis was 4.2%. Sustained hypotension after spinal anesthesia, which occurred in 12.3% of the cohort, was associated with increased risk for neonatal acidosis (aRR 3.96, 95% CI 1.21-12.98), but was not associated with CNAO or CMAO. Time from spinal-to-delivery was not different in those with and without neonatal acidosis. CONCLUSION: Despite universal exposure to prophylactic vasopressors, sustained hypotension after spinal anesthesia was still associated with neonatal acidosis, but no other adverse perinatal outcomes. Our findings may provide additional support for the adoption of prophylactic vasopressors to reduce spinal hypotension and downstream effects on the neonate from intraoperative hemodynamic instability. KEY POINTS: · Despite prophylactic vasopressors during scheduled CD, neonatal acidosis occurred in 4% of subjects.. · Sustained hypotension after spinal anesthesia was associated with neonatal acidosis, but not adverse neonatal outcomes.. · Spinal-to-delivery time was not associated with neonatal acidosis in scheduled CD..

Maternal Education Level Among People with Diabetes and Associated Adverse Outcomes.

OBJECTIVE: The aim of the study is to determine the relation between education and adverse outcomes in individuals with pregestational or gestational diabetes. STUDY DESIGN: This population-based cohort study, using the U.S. vital statistics datasets, evaluated individuals with pregestational or gestational diabetes who delivered between 2016 and 2019. The primary outcome was composite neonatal adverse outcome including any of the following: large for gestational age (LGA), Apgar's score 6 hours, neonatal seizure, or neonatal death. The secondary outcome was composite maternal adverse outcomes including any of the following: admission to intensive care unit, transfusion, uterine rupture, or unplanned hysterectomy. Multivariable analysis was used to estimate adjusted relative risks (aRR) and 95% confidence intervals (CIs). RESULTS: Of 15,390,962 live births in the United States, 858,934 (5.6%) were eligible for this analysis. Compared with individuals with a college education and above, the risk of composite neonatal adverse outcome was higher in individuals with some college (aRR = 1.08, 95% CI = 1.07-1.09), high school (aRR = 1.06, 95% CI = 1.04-1.07), and less than high school (aRR = 1.05, 95% CI = 1.03-1.07) education. The components of composite neonatal adverse outcome that differed significantly between the groups were LGA, Apgar's score 6 hours. Infant death differed when stratified by education level. An increased risk of composite maternal adverse outcome was also found with a lower level of education. CONCLUSION: Among individuals with diabetes, lower education was associated with a modestly higher risk of adverse neonatal and maternal outcomes. KEY POINTS: · Education levels were associated with adverse outcomes among individuals with diabetes.. · Lower education is associated with multiple neonatal complications, including infant death.. · Individuals with varying levels of education are at higher risk for adverse maternal outcomes..

Gestational diabetes mellitus and late preterm birth: outcomes with and without antenatal corticosteroid exposure.

BACKGROUND: Unlike pregestational diabetes mellitus, the American College of Obstetricians and Gynecologists recommends antenatal corticosteroids in those with gestational diabetes mellitus at risk for preterm birth. However, this recommendation is based on limited data, only 10.6% of the Antenatal Late Preterm Steroids study sample had gestational diabetes mellitus. There is a paucity of data on the risk of neonatal respiratory and other morbidity in this population. OBJECTIVE: This study aimed to examine respiratory outcomes in parturients with gestational diabetes mellitus who received antenatal corticosteroids and delivered during the late preterm period vs those who did not. STUDY DESIGN: This population-based cohort study used the US Vital Statistics dataset between 2016 to 2020. The inclusion criteria were singleton, nonanomalous individuals who delivered between 34.0 to 36.6 weeks with gestational diabetes mellitus and known status of antepartum corticosteroid exposure. The primary outcome, a composite neonatal adverse outcome, included Apgar score <5 at 5 minutes, immediate assisted ventilation, assisted ventilation >6 hours, surfactant use, seizure, or neonatal mortality. The secondary outcome was a composite maternal adverse outcome, including maternal blood transfusion, ruptured uterus, unplanned hysterectomy, and admission to the intensive care unit. Multivariable Poisson regression models were used to estimate adjusted relative risks and 95% confidence intervals. Average annual percent change was calculated to assess changes in rates of corticosteroid exposure over the study period. RESULTS: Of 19 million births during the study period, 110,197 (0.6%) met the inclusion criteria, and among them, 23,028 (20.9%) individuals with gestational diabetes mellitus received antenatal corticosteroids. The rate of antenatal steroid exposure remained stable over the 5 years (APC=10.7; 95% confidence interval, -5.4 to 29.4). The composite neonatal adverse outcome was significantly higher among those who received corticosteroids than among those who did not (137.1 vs 216.5 per 1000 live births; adjusted relative risk 1.24; 95% confidence interval, 1.20-1.28). Three components of the composite neonatal adverse outcome-immediate assisted ventilation, intubation >6 hours, and surfactant use-were significantly higher with exposure than without. In addition, the composite maternal adverse outcome was significantly higher among those who received corticosteroids (adjusted relative risk, 1.34; 95% confidence interval, 1.18-1.52). Three components of the composite maternal adverse outcome-admission to intensive care unit, blood transfusion, and unplanned hysterectomy-were significantly higher among the exposed group. Subgroup analysis, among large for gestational age, by gestational age, and race and ethnicity, confirm the trend of increased likelihood of adverse outcomes with exposure to corticosteroid. CONCLUSION: Individuals with gestational diabetes mellitus and antenatal corticosteroid exposure, who delivered in the late preterm, were at higher risk of neonatal and maternal adverse outcomes than those unexposed to corticosteroid.