Impaired awareness of hypoglycaemia: A new risk factor for adverse pregnancy outcomes in type 1 diabetes.

AIM: The aim of this study is to evaluate the impact of impaired awareness of hypoglycaemia (IAH) on metabolic control and pregnancy outcomes in women with type 1 diabetes. MATERIAL AND METHODS: This was a single-centre prospective cohort study of singleton pregnant women with type 1 diabetes. IAH was assessed at the first antenatal visit using Clarke's test (score ≥ 3). Data on metabolic control, hypoglycaemic events, and the lipid profile were collected from prior to pregnancy and in each trimester of gestation. Pregnancy outcomes were also recorded. RESULTS: A total of 77 patients with type 1 diabetes were included; 24 (31.2%) were classified as having IAH. Compared with the normal awareness of hypoglycaemia (NAH) group, the IAH group did not show differences in HbA1c , weight gain, insulin doses, or severe and nonsevere hypoglycaemia events throughout pregnancy. IAH was associated with higher triglyceride concentrations in the second trimester (IAH: 154.8 ± 61.1 mg/dL, NAH: 128.6 ± 31.2 mg/dL, P = .034) and an increased risk of neonatal respiratory distress (odds ratio [OR] 11.24; 95% CI, 1.01-124.9, P = .041) in adjusted models. Increased risk of pre-eclampsia was related to higher second trimester triglyceride concentrations (OR 1.028; 95% CI, 1.004-1.053, P = .023) adjusted for confounders. CONCLUSIONS: The IAH was associated with increased risk of neonatal respiratory distress and pre-eclampsia, despite showing no differences in metabolic control. Hypoglycaemia awareness in the first antenatal visit should be assessed to identify the subgroup of pregnant women with increased risk of complications.

Impaired hypoglycaemia awareness in early pregnancy increases risk of severe hypoglycaemia in the mid-long term postpartum irrespective of breastfeeding status in women with type 1 diabetes.

INTRODUCTION: Information regarding the postpartum period in women with type 1 diabetes (T1D) is scarce. We aim to evaluate the relation of impaired hypoglycaemia awareness (IAH) in early pregnancy and breastfeeding status (its presence and duration) with severe postpartum hypoglycaemia (SH). MATERIALS AND METHODS: Retrospective cohort study of women with T1D followed during pregnancy between 2012 and 2019. Data on SH were recorded before and during pregnancy. IAH was evaluated at the first antenatal visit. Data on breastfeeding and the long-term postpartum period were collected by questionnaire and from medical records. RESULTS: A total of 89 women with T1D were included with a median follow-up after pregnancy of 19.2 [8.7-30.5] months. Twenty-eight (32%) women had IAH at the first antenatal visit. At discharge, 74 (83%) started breastfeeding during a median of 8 [4.4-15] months. A total of 18 (22%) women experienced ≥1 SH during postpartum. The incidence of SH significantly increased from pregestational to the gestational and post-partum period (0.09, 0.15 and 0.25 episodes/patient-year, respectively). Postpartum SH rates were comparable in breastfeeding and non-breastfeeding women (21.4% vs. 25%, respectively, p>0.05). Clarke test score at the first antenatal visit was associated with postpartum SH (for each 1-point increase: OR 1.53; 95% CI, 1.06-2.21) adjusted for confounders. No other diabetes and pregnancy-related variables were identified as predictors of SH in this period. CONCLUSIONS: SH are common in the long-term postpartum period independently of breastfeeding. Assessing IAH in early pregnancy could identify those at an increased risk of SH in the postpartum period.

Pre-pregnancy overweight and obesity prevalence and relation to maternal and perinatal outcomes.

OBJECTIVE: To identify the prevalence of pre-pregnancy overweight/obesity in pregnant women and its relationship with socio-demographic factors and to describe the maternal and perinatal outcomes in a Barcelona hospital (Spain). METHOD: A descriptive cross-association study, with retrospective data collection, was performed Barcelona Hospital. The data of 5447 pregnant women who delivered at >=23 weeks of gestation were included. Body Mass Index (BMI) data were categorised into World Health Organization classifications. p values <.05 (two-tailed) were considered significant. Logistic regression models were performed. RESULTS: The prevalence of pre-pregnancy obesity was 8.4% and 18.9% for overweight. Gestational diabetes was more frequent in pre-pregnancy overweight/obesity (OR 1.92: 95% CI 1.54-2.40 and OR 3.34: 95% CI 2.57-4.33), as were preeclampsia (OR 2.08: 95% CI 1.55-2.79 and OR 3.35: 95% CI 2.38-4.71), induction of labour (OR 1.19: 95% CI 1.02-1.38 and OR 1.94: 95% CI 1.57-2.10), caesarean section (OR 1.41: 95% CI 1.21-1.65 and OR 2.68: 95% CI 2.18-3.29), prematurity (OR 1.28: 95% CI 1-1.65 and OR 1.79: 95% CI 1.32-2.44) and macrosomia (OR 1.87: 95% CI 1.43-2.46 and OR 2.03: 95% CI 1.40-2.93). CONCLUSIONS: One in four pregnant women had pre-pregnancy overweight or obesity. This study shows the relationship between pre-pregnancy overweight or obesity with adverse maternal and perinatal outcomes.

Effectiveness of a Step Counter Smartband and Midwife Counseling Intervention on Gestational Weight Gain and Physical Activity in Pregnant Women With Obesity (Pas and Pes Study): Randomized Controlled Trial.

BACKGROUND: Women who are pregnant and have obesity and excessive gestational weight gain (GWG) present a higher risk of maternal and perinatal complications. The use of mobile apps and a wristband during pregnancy may contribute to promoting healthy lifestyles and, thus, improving maternal and neonatal health. OBJECTIVE: This study aims to evaluate the effectiveness of a complex digital health intervention, using a smartband and app with midwife counseling, on GWG and physical activity (PA) in women who are pregnant and have obesity and analyze its impact on maternal and perinatal outcomes. In addition, we aim to study the frequency of use, usability, and satisfaction with the mobile apps used by the women in the intervention group. METHODS: A parallel, 2-arm, randomized controlled trial was conducted. A total of 150 women who were pregnant and had obesity were included. The intervention group received a complex combined digital intervention. The intervention was delivered with a smartband (Mi Band 2) linked to the app Mi Fit to measure PA and the Hangouts app with the midwife to provide personal health information. The control group received usual care. The validated Spanish versions of the International Physical Activity Questionnaire-Short Form and the System Usability Scale were used. Satisfaction was measured on a 1- to 5-point Likert scale. RESULTS: We analyzed 120 women, of whom 30 (25%) were withdrawn because of the COVID-19 pandemic. The median GWG in the intervention group was 7.0 (IQR 4-11) kg versus 9.3 (IQR 5.9-13.3) kg in the control group (P=.04). The adjusted mean GWG per week was 0.5 (95% CI 0.4-0.6) kg per week in the control group and 0.3 (95% CI 0.3-0.4) kg per week in the intervention group (df=0.1, 95% CI -0.2 to 0.03; P=.008). During the 35 and 37 gestational weeks, women in the intervention group had higher mean PA than women in the control group (1980 metabolic equivalents of tasks-minutes per week vs 1386 metabolic equivalents of tasks-minutes per week, respectively; P=.01). No differences were observed between the study groups in the incidence of maternal and perinatal outcomes. In the intervention group, 61% (36/59) of the women who were pregnant used the smartband daily, and 75% (44/59) evaluated the usability of the Mi Fit app as excellent. All women in the intervention group used the Hangouts app at least once a week. The mean of the satisfaction scale with the health counseling app and midwife support was 4.8/5 (SD 0.6) points. CONCLUSIONS: The use of a complex mobile health intervention was associated with adequate GWG, which was lower in the intervention group than in the control group. In addition, we observed that the intervention group had increases in PA. No differences were observed in maternal perinatal complications. TRIAL REGISTRATION: ClinicalTrials.gov NCT03706872; https://www.clinicaltrials.gov/ct2/show/NCT03706872.

Pre-pregnancy overweight and obesity prevalence and relation to maternal and perinatal outcomes.

OBJECTIVE: To identify the prevalence of pre-pregnancy overweight/obesity in pregnant women and its relationship with socio-demographic factors and to describe the maternal and perinatal outcomes in a Barcelona hospital (Spain). METHOD: A descriptive cross-association study, with retrospective data collection, was performed Barcelona Hospital. The data of 5447 pregnant women who delivered at >=23 weeks of gestation were included. Body Mass Index (BMI) data were categorised into World Health Organization classifications. p values <.05 (two-tailed) were considered significant. Logistic regression models were performed. RESULTS: The prevalence of pre-pregnancy obesity was 8.4% and 18.9% for overweight. Gestational diabetes was more frequent in pre-pregnancy overweight/obesity (OR 1.92: 95% CI 1.54-2.40 and OR 3.34: 95% CI 2.57-4.33), as were preeclampsia (OR 2.08: 95% CI 1.55-2.79 and OR 3.35: 95% CI 2.38-4.71), induction of labour (OR 1.19: 95% CI 1.02-1.38 and OR 1.94: 95% CI 1.57-2.10), caesarean section (OR 1.41: 95% CI 1.21-1.65 and OR 2.68: 95% CI 2.18-3.29), prematurity (OR 1.28: 95% CI 1-1.65 and OR 1.79: 95% CI 1.32-2.44) and macrosomia (OR 1.87: 95% CI 1.43-2.46 and OR 2.03: 95% CI 1.40-2.93). CONCLUSIONS: One in four pregnant women had pre-pregnancy overweight or obesity. This study shows the relationship between pre-pregnancy overweight or obesity with adverse maternal and perinatal outcomes.

Gestational age-specific cutoff levels of TDx-FLM II for the prediction of neonatal respiratory distress syndrome.

AIM: To construct a predictive model for respiratory distress syndrome (RDS) from gestational age (GA) at delivery and TDx-FLM II value. METHODS: Pregnant women who underwent an amniocentesis in which TDx-FLM II was determined were included in the study. A model for the occurrence of RDS was constructed by means of a logistic regression procedure from TDx-FLM II values and GA at delivery. RESULTS: The mean value of TDx-FLM II was 47.11 mg/g. The mean GA at delivery was 33.4 weeks. The incidence of RDS was 7.8% (18/231). The optimal cutoff of predicted risk for respiratory distress was found to be 8.8%, resulting in a sensitivity and specificity of 89 and 83%, respectively. CONCLUSIONS: The adjustment of the TDx-FLM II value for GA at delivery results in a significant improvement in the predictive capacity of the test for the occurrence of RDS. The use of GA-specific cutoff values may simplify clinical decisions.

Prepregnancy care in women with type 1 diabetes improves HbA1c and glucose variability without worsening hypoglycaemia time and awareness: Glycaemic variability during prepregnancy care.

AIMS: To evaluate the impact of a prepregnancy care (PPC) programme, beyond HbA1c, on hypoglycaemia awareness and glycaemic variability (GV). METHODS: Prospective pilot study. We selected women with Type 1 diabetes who initiated a PPC programme with normal hypoglycaemia awareness (n = 24). Hypoglycaemia awareness, hypoglycaemic events and GV derived from masked-continuous glucose monitoring were evaluated in the first visit and within 2 weeks after pregnancy confirmation. RESULTS: The duration was 16.5 ±â€¯13.0 months. HbA1c significantly decreased (-0.8 ±â€¯0.7; p < 0.001). The Clarke score increased (0[0-1] vs. 1[0-2] points, p = 0.164), 2 out of 24 were reclassified as having impaired awareness of hypoglycaemia and 2 presented severe hypoglycaemia. GV decreased: standard deviation (p = 0.008), coefficient of variation (p = 0.021), mean amplitude of glycaemic excursions (p = 0.007), average daily risk range (p < 0.001), J-index (p = 0.010), high blood glucose index (HBGI) (p = 0.004), continuous overall net glycaemic action (CONGA) (p = 0.018), mean of daily differences (p = 0.045) and glycaemic risk assessment diabetes equation (p = 0.012). Final HbA1c was associated with baseline J-index, CONGA and HBGI (ß = 0.535, ß = 0.466, ß = 0.534, respectively; p < 0.05). CONCLUSIONS: A PPC programme improved HbA1c as well as GV with no significant impact on hypoglycaemia awareness. Moreover, GV could help to identify women less likely to achieve glycaemic targets. Larger studies are needed to confirm these results.

Postpartum metabolic control in a cohort of women with type 1 diabetes.

BACKGROUND AND OBJECTIVE: Pregnancy in women with type 1 diabetes (T1D) involves greater risks as compared to non-diabetic women, but less information is available about blood glucose and weight control after delivery. Our aim was to evaluate the postpartum metabolic profile (blood glucose and weight control) of women with T1D and the factors related to those metabolic outcomes. METHODS: A retrospective, observational study of 36 women with T1D during pregnancy and for up to one year after delivery. RESULTS: Fifty percent of patients attended a preconceptional planning program (PPP), and 44.4% of women were treated with continuous subcutaneous insulin infusion. Mean preconceptional HbA1c and body mass index (BMI) were 7.2±1.2% and 23.8±5.0 respectively. In the total cohort, blood glucose control significantly worsened one year after delivery (HbA1c: 7.2±1.2 vs 7.6±1.2%, P<0.001). Lower preconceptional HbA1c values were found in patients who attended PPP (6.6±0.5 vs. 7.8±1.4%; P=0.02), and were maintained for one year after delivery. No differences were found in body mass index (BMI) from the pregestational period to one year after delivery in any of two groups (No PPP 22.5±4.6 vs 23.2±4.8, P=0.078; PPP 25.4±3.4 vs 25.5±3.4 kg/m(2), P=0.947). Preconceptional HbA1c was shown to be the most important determinant of metabolic control (ß=0.962, p<0.001) and weight one year after delivery (ß=0.524, p=0.025) and weight gain during pregnancy (ß=0.633, p=0.004). CONCLUSIONS: Pregnant women with T1D return to prepregnancy body weight one year after delivery, especially those with lower HbA1c levels and BMI before pregnancy. However, blood glucose control deteriorates after delivery, suggesting the need for changes in clinical practice after delivery.

Obstetric and perinatal outcome in women with twin pregnancy and gestational diabetes.

OBJECTIVE: The aim of this study was to evaluate pregnancy complications and obstetric and perinatal outcomes in women with twin pregnancy and GDM. STUD DESIGN: An observational multicentre retrospective study was performed and 534 pregnant woman and 1068 twins infants allocated into two groups, 257 with GDM and 277 controls, were studied. MAIN OUTCOME MEASURES: Pregnant women characteristics, hypertensive complications, preterm delivery rate, mode of delivery and birthweight were analysed. RESULTS: Pregnant women with GDM were older (p < 0.001) and had higher body mass index (p < 0.001) than controls. GDM was associated with higher risk of prematurity in twin pregnancy (odds ratio 1.64, 95% confidence interval [1.14-2.32], p = 0.005). This association was based on the association with other pregnancy complications. Birthweight Z-scores were significantly higher in the GDM group (p = 0.02). The rate of macrosomia was higher in the GDM group (p = 0.002) and small for gestational age (SGA) babies were significantly less frequent (p = 0.03). GDM was an independent predictor of macrosomia (p = 0.006). CONCLUSION: The presence of GDM in twin pregnancy was associated with a higher risk of hypertensive complications, prematurity and macrosomia, but significantly reduces the risk of SGA infants. Prematurity was related to the presence of other associated pregnancy complications.