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Comparative effectiveness of adjunct non-pharmacological interventions on maternal and neonatal outcomes in gestational diabetes mellitus patients: A systematic review and network meta-analysis protocol of randomized controlled trials.
Saha, S
PloS one. 2022;(1):e0263336
Abstract
BACKGROUND Gestational diabetes mellitus (GDM) in pregnancy leads to a range of perinatal complications. Although several randomized controlled trials (RCT) have tested the effect of non-pharmacological standard GDM care adjuncts on these outcomes, there is no agglomerated statistical evidence on how their occurrence risk varies across interventions and with placebo. Therefore, a systematic review and network meta-analysis (NMA) protocol is proposed here to address this evidence gap. MATERIALS AND METHODS A search for above RCTs published in the English language will transpire in PubMed, Embase, and Scopus databases irrespective of date and geographic boundary. The RCTs must test nutritional supplementation, digital intervention, structured exercise program, educational program, counseling service, or a combination of these prenatally in GDM patients. These should report ≥1 of the following outcomes- cesarean section, pre-eclampsia, polyhydramnios, preterm birth, macrosomia, prolonged labor, gestational hypertension, premature rupture of membranes, congenital anomaly, Apgar scores, birth weight, birth length, gestational age at birth, neonatal hypoglycemia, neonatal hyperbilirubinemia, and neonatal Corpulence Index. The risk of bias assessment of the recruited trials will transpire using the Revised Cochrane risk-of-bias tool. Determination of the comparative effectiveness between interventions will occur by the frequentist method NMA for respective outcomes. The categorical and continuous outcomes effect size will get calculated in risk ratio and weighted or standardized mean difference, respectively. For each NMA model, network maps and league tables will show the connections between interventions and effect sizes with their 95% confidence intervals for each intervention pair compared, respectively. The publication bias assessment will occur using comparison-adjusted funnel plots. Best intervention prediction for NMA models with statistically significant intervention effect will happen by determining the surface under the cumulative ranking curve values. Statistical analysis will ensue using Stata software (v16). The statistical significance estimation will happen at p<0.05 and 95% confidence interval. TRIAL REGISTRATION PROSPERO registration no: CRD42021271199; https://clinicaltrials.gov/.
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Prenatal docosahexaenoic acid supplementation has long-term effects on childhood behavioral and brain responses during performance on an inhibitory task.
Gustafson, KM, Liao, K, Mathis, NB, Shaddy, DJ, Kerling, EH, Christifano, DN, Colombo, J, Carlson, SE
Nutritional neuroscience. 2022;(1):80-90
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Abstract
Introduction: Offsprings from a prenatal docosahexaenoic acid (DHA) supplementation trial, in which pregnant women were assigned to placebo or 600mg DHA/day, were followed to determine the effect of prenatal DHA supplementation on the behavior and brain function at 5.5 years (n=81 placebo, n=86 supplemented).Methods: Event-related potentials (ERP) were recorded during a visual task requiring a button press (Go) to frequent target stimuli and response inhibition to the rare stimuli (No-Go). Univariate ANOVAs were used to test differences between group and sex for behavioral measures. ERP differences were tested using a three-way mixed-design multivariate analysis of variance (MANOVA).Results: There was a significant sex × group interaction for hit rate and errors of omission; there was no difference between males and females in the placebo group, but DHA males outperformed DHA females. Males overall and the placebo group made more errors requiring response inhibition; DHA females were significantly better than placebo females and DHA males. ERP P2 amplitude was larger in the DHA group. A significant N2 amplitude condition effect was observed in females and DHA group males, but not in placebo group males.Discussion: Prenatal DHA supplementation improved inhibitory performance overall, especially for females in the DHA group, possibly accounting for their conservative behavior during Go trials. Development of brain regions responsible for visual processing may be sensitive to maternal DHA status, evidenced by greater P2 amplitude. Males may benefit more from maternal DHA supplementation, indicated by the N2 condition effect seen only in males in the DHA group.
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Effectiveness of carbohydrate counting and Dietary Approach to Stop Hypertension dietary intervention on managing Gestational Diabetes Mellitus among pregnant women who used metformin: A randomized controlled clinical trial.
Allehdan, S, Basha, A, Hyassat, D, Nabhan, M, Qasrawi, H, Tayyem, R
Clinical nutrition (Edinburgh, Scotland). 2022;(2):384-395
Abstract
BACKGROUND Gestational diabetes mellitus (GDM) is one of the most common complication of pregnancy that has significant impacts on both mother and her offspring health. The present study aimed to examine the effect of carbohydrate counting, carbohydrate counting combined with DASH, and control dietary interventions on glycemic control, and maternal and neonatal outcomes. METHODS A total of 75 pregnant women with GDM at 24th - 30th week of gestation were enrolled and randomized to follow one of the three diets: control or carbohydrate counting, or carbohydrate counting combined with Dietary Approach to Stop Hypertension (DASH). Only 70 of them completed the study until delivery. Fasting blood samples were taken at baseline and the end of the study to measure fasting blood glucose (FBG), fasting insulin, glycated hemoglobin (HbA1c), and fructosamine. Homeostatic model assessment-insulin resistance (HOMA-IR) score was calculated using HOMA2 calculator program. The participants recorded at least four blood glucose readings per day. Maternal and neonatal outcomes were collected from medical records. Dietary intake was assessed by three-day food records at the baseline and the end of the study. RESULTS Adherence to the three dietary interventions, resulted in decreased FBG levels significantly among all the participants (P < 0.05). Consumption of the carbohydrate counting combined with the DASH diet showed significant reduction in serum insulin levels and HOMA-IR score compared to carbohydrate counting group and control group. Means of fructosamine and HbA1c did not differ significantly among the three intervention diet groups. Overall mean of 1-h postprandial glucose (1 h PG) level was significantly lower in the carbohydrate counting combined with DASH group compared with that in the carbohydrate counting group and the control group (P < 0.001). The number of women who were required to commence insulin therapy after dietary intervention was significantly lower in carbohydrate counting group and carbohydrate counting combined with DASH group (P = 0.026). There were no significant differences in other maternal and neonatal outcomes among the three dietary intervention groups. CONCLUSIONS The carbohydrate counting and the carbohydrate counting combined with DASH dietary interventions resulted in beneficial effects on FBG and 1 h PG compared with the control diet. The three dietary interventions produced similar maternal and neonatal outcomes in women with GDM. TRIAL REGISTRATION This trial was registered on ClinicalTrials.gov under the identification code: NCT03244579. https://clinicaltrials.gov/ct2/show/NCT03244579.
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Managing hyperglycaemia during antenatal steroid administration, labour and birth in pregnant women with diabetes - an updated guideline from the Joint British Diabetes Society for Inpatient Care.
Dashora, U, Levy, N, Dhatariya, K, Willer, N, Castro, E, Murphy, HR, ,
Diabetic medicine : a journal of the British Diabetic Association. 2022;(2):e14744
Abstract
This article summarises the Joint British Diabetes Societies for Inpatient Care guidelines on the management of glycaemia in pregnant women with diabetes on obstetric wards and delivery units, Joint British Diabetes Societies (JBDS) for Inpatient Care Group, ABCD (Diabetes Care) Ltd. The updated guideline offers two approaches - the traditional approach with tight glycaemic targets (4.0-7.0 mmol/L) and an updated pragmatic approach (5.0-8.0 mmol/L) to reduce the risk of maternal hypoglycaemia whilst maintaining safe glycaemia. This is particularly relevant for women with type 1 diabetes who are increasingly using Continuous Glucose Monitoring (CGM) and Continuous Subcutaneous Insulin Infusion (CSII) during pregnancy. All women with diabetes should have a documented delivery plan agreed during antenatal clinic appointments. Hyperglycaemia following steroid administration can be managed either by increasing basal and prandial insulin doses, typically by 50% to 80%, or by adding a variable rate of intravenous insulin infusion (VRIII). Glucose levels, either capillary blood glucose or CGM glucose levels, should be measured at least hourly from the onset of established labour, artificial rupture of membranes or admission for elective caesarean section. If intrapartum glucose levels are higher than 7.0 or 8.0 mmol/L on two consecutive occasions, VRIII is recommended. Hourly capillary blood glucose rather than CGM glucose measurements should be used to adjust VRIII. The recommended substrate fluid to be administered alongside a VRIII is 0.9% sodium chloride solution with 5% glucose and 0.15% potassium chloride (KCl) (20 mmol/L) or 0.3% KCl (40 mmol/L) at 50 ml/hr. Both the VRIII and CSII rates should be reduced by at least 50% after delivery.
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Pilot Randomized Controlled Trial of Diabetes Group Prenatal Care.
Carter, EB, Barbier, K, Hill, PK, Cahill, AG, Colditz, GA, Macones, GA, Tuuli, MG, Mazzoni, SE
American journal of perinatology. 2022;(1):45-53
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OBJECTIVE This study aimed to determine the feasibility and effectiveness of Diabetes Group Prenatal Care to increase patient engagement in diabetes self-care activities. STUDY DESIGN A pilot randomized controlled trial was conducted at two sites. Inclusion criteria were English or Spanish speaking, type 2 or gestational diabetes, 22 to 34 weeks of gestational age at first study visit, ability to attend group care at specified times, and willingness to be randomized. Exclusion criteria included type 1 diabetes, multiple gestation, major fetal anomaly, serious medical comorbidity, and serious psychiatric illness. Women were randomized to Diabetes Group Prenatal Care or individual prenatal care. The primary outcome was completion of diabetes self-care activities, including diet, exercise, blood sugar testing, and medication adherence. Secondary outcomes included antenatal care characteristics, and maternal, neonatal, and diabetes management outcomes. Analysis followed the intention-to-treat principle. RESULTS Of 159 eligible women, 84 (53%) consented to participate in the study and were randomized to group (n = 42) or individual (n = 42) prenatal care. Demographic characteristics were similar between study arms. Completion of diabetes self-care activities was similar overall, but women in group care ate the recommended amount of fruits and vegetables on more days per week (5.1 days/week ± 2.0 standard deviation [SD] in group care vs. 3.4 days ± 2.6 SD in individual care; p < 0.01) and gained less weight per week during the study period (0.2 lbs/week [interquartile range: 0-0.7] vs. 0.5 lbs/week [interquartile range: 0.2-0.9]; p = 0.03) than women in individual care. Women with gestational diabetes randomized to group care were 3.5 times more likely to have postpartum glucose tolerance testing than those in individual care (70 vs. 21%; relative risk: 3.5; 95% confidence interval: 1.4-8.8). Other maternal, neonatal, and pregnancy outcomes were similar between study arms. CONCLUSION Diabetes group care is feasible and shows promise for decreasing gestational weight gain, improving diet, and increasing postpartum diabetes testing among women with pregnancies complicated by diabetes. KEY POINTS · Women with gestational diabetes in group care were 3.5 times more likely to return for postpartum glucose tolerance testing.. · Women with gestational diabetes in group care had less gestational weight gain during the study period.. · Diabetes Group Prenatal Care is a promising intervention to improve outcomes for women with diabetes in pregnancy..
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Pregnancy after bariatric surgery: Effects of personalized nutrition counseling on pregnancy outcomes.
Araki, S, Shani Levi, C, Abutbul Vered, S, Solt, I, Rozen, GS
Clinical nutrition (Edinburgh, Scotland). 2022;(2):288-297
Abstract
BACKGROUND & AIMS Nutritional challenges following bariatric surgery can be intensified during pregnancy and may have crucial effects on the fetus, including lower birth weight. To the best of our knowledge, the effect of nutritional counseling during post-bariatric pregnancy to improve maternal diet quality and eating habits on neonatal outcome has not been evaluated. The aim of this research was to examine the effects of personal nutritional counseling during post-bariatric pregnancy on nutritional intake and neonatal outcomes. METHODS We performed a non-randomized, intervention-control clinical trial. Women (n = 61) were divided into three groups; two prospective, and one retrospective: 1. An Intervention Bariatric Prospective group 2. A Control Prospective group without surgery, and 3. A Control Bariatric Retrospective group. Patient enrollment was performed from April 2016 to March 2018. The intervention program included biweekly visits with a pregnancy nutrition certified bariatric dietitian. Data collection was performed four times during pregnancy, and included demographic and eating habits questionnaires, 24 h dietary recall, and information about delivery outcomes. In the retrospective group delivery outcomes and Food Frequency Questionnaire was collected once, after delivery. RESULTS There were no differences between groups at baseline except for a higher pre-pregnancy BMI in the post-bariatric groups. In the prospective groups, dietary protein, energy, and iron were found to be consumed in higher amounts in the Control-Prospective group than in the Intervention Bariatric-Prospective group (p < 0.05), without the addition of supplements. On the other hand, iron and calcium calculated from diet with supplements, were found to be significantly higher in the Intervention Bariatric Prospective group than in the Control Prospective group. In addition, consumption of saturated fats, oil, and salty snacks was lower in both prospective groups compared to the retrospective group (p < 0.05), suggesting better food quality habits for the bariatric group with nutritional counseling. Mean birth weight was significantly lower in the Control Bariatric Retrospective group than in the Control-Prospective group (3074 ± 368 g vs. 3396 ± 502 g, respectively. p = 0.023). In the Intervention Bariatric Prospective group, mean birth weight was 3168 ± 412 g, and no significant difference was observed from the Control Prospective group. Birth percentiles were also significantly lower in the Control Bariatric Retrospective group compared to the Control Prospective group (27th vs. 42nd, respectively. p < 0.05). In the Intervention Bariatric Prospective group, mean birth percentile was 35th, and no significant difference was observed from the Control Prospective group. As for the weight change of the woman during pregnancy, the highest variability was noted among the Control Bariatric Retrospective group with cases of weight loss up to 37 kg, due to conception close to the bariatric operation. Nevertheless, this variable was controlled, and showed no significant impact on birth weight results. CONCLUSIONS Our results suggest that personalized nutritional counseling care during post bariatric pregnancy improved nutrient intake of mothers and may contribute to higher birth weight of offspring. Further research is needed to examine the effects of prenatal nutrition care intervention, in addition to repeating this trial with a larger sample size, to allow for clearer findings. CLINICAL TRIAL REGISTRATION IRB number: 0310-15-RMB. IDENTIFICATION NIH NUMBER NCT02697981 URL: https://www.nih.gov.
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Effects of iodine supplementation during pregnancy on pregnant women and their offspring: a systematic review and meta-analysis of trials over the past 3 decades.
Nazeri, P, Shariat, M, Azizi, F
European journal of endocrinology. 2021;(1):91-106
Abstract
OBJECTIVE The current systematic review aimed to provide comprehensive data on the effects of iodine supplementation in pregnancy and investigate its potential benefits on infant growth parameters and neurocognitive development using meta-analysis. METHODS A systematic review was conducted on trials published from January 1989 to December 2019 by searching MEDLINE, Web of Science, the Cochrane Library, Scopus, and Google Scholar. For most maternal and neonatal outcomes, a narrative synthesis of the data was performed. For birth anthropometric measurements and infant neurocognitive outcomes, the pooled standardized mean differences (SMDs) with 95% CIs were estimated using fixed/random effect models. RESULTS Fourteen trials were eligible for inclusion in the systematic review, of which five trials were included in the meta-analysis. Although the findings of different thyroid parameters are inconclusive, more consistent evidence showed that iodine supplementation could prevent the increase in thyroglobulin concentration during pregnancy. In the meta-analysis, no differences were found in weight (-0.11 (95% CI: -0.23 to 0.01)), length (-0.06 (95% CI: -0.21 to 0.09)), and head circumference (0.26 (95% CI: -0.35 to 0.88)) at birth, or in cognitive (0.07 (95% CI: -0.07 to 0.20)), language (0.06 (95% CI: -0.22 to 0.35)), and motor (0.07 (95% CI: -0.06 to 0.21)) development during the first 2 years of life in infants between the iodine-supplemented and control groups. CONCLUSION Iodine supplementation during pregnancy can improve the iodine status in pregnant women and their offspring; however, according to our meta-analysis, there was no evidence of improved growth or neurodevelopmental outcomes in infants of iodine-supplemented mothers.
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Pregnancy and COVID-19: pharmacologic considerations.
D'Souza, R, Ashraf, R, Rowe, H, Zipursky, J, Clarfield, L, Maxwell, C, Arzola, C, Lapinsky, S, Paquette, K, Murthy, S, et al
Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology. 2021;(2):195-203
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In this review, we summarize evidence regarding the use of routine and investigational pharmacologic interventions for pregnant and lactating patients with coronavirus disease 2019 (COVID-19). Antenatal corticosteroids may be used routinely for fetal lung maturation between 24 and 34 weeks' gestation, but decisions in those with critical illness and those < 24 or > 34 weeks' gestation should be made on a case-by-case basis. Magnesium sulfate may be used for seizure prophylaxis and fetal neuroprotection, albeit cautiously in those with hypoxia and renal compromise. There are no contraindications to using low-dose aspirin to prevent placenta-mediated pregnancy complications when indicated. An algorithm for thromboprophylaxis in pregnant patients with COVID-19 is presented, which considers disease severity, timing of delivery in relation to disease onset, inpatient vs outpatient status, underlying comorbidities and contraindications to the use of anticoagulation. Nitrous oxide may be administered for labor analgesia while using appropriate personal protective equipment. Intravenous remifentanil patient-controlled analgesia should be used with caution in patients with respiratory depression. Liberal use of neuraxial labor analgesia may reduce the need for emergency general anesthesia which results in aerosolization. Short courses of non-steroidal anti-inflammatory drugs can be administered for postpartum analgesia, but opioids should be used with caution due to the risk of respiratory depression. For mechanically ventilated pregnant patients, neuromuscular blockade should be used for the shortest duration possible and reversal agents should be available on hand if delivery is imminent. To date, dexamethasone is the only proven and recommended experimental treatment for pregnant patients with COVID-19 who are mechanically ventilated or who require supplemental oxygen. Although hydroxycholoroquine, lopinavir/ritonavir and remdesivir may be used during pregnancy and lactation within the context of clinical trials, data from non-pregnant populations have not shown benefit. The role of monoclonal antibodies (tocilizumab), immunomodulators (tacrolimus), interferon, inhaled nitric oxide and convalescent plasma in pregnancy and lactation needs further evaluation. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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Nutrition as Prevention Factor of Gestational Diabetes Mellitus: A Narrative Review.
Mierzyński, R, Poniedziałek-Czajkowska, E, Sotowski, M, Szydełko-Gorzkowicz, M
Nutrients. 2021;(11)
Abstract
Gestational diabetes mellitus (GDM) is defined as a glucose tolerance disorder with onset or first recognition during pregnancy. GDM is associated with several adverse maternal and neonatal outcomes. Management to reduce the incidence of GDM could decrease the incidence of these complications. Modification of nutrition in the prevention of GDM is postulated. The vital issue in GDM prevention is the implementation of proper dietary patterns, appropriate physical activity, and a combination of diet and lifestyle modifications. However, intervention studies examining the effects of diet and lifestyle on GDM prevention are contradictory. The aim of this study was to review the scientific evidence on nutritional prevention strategies, including diet and supplementation of some substances such as probiotics, micro/macroelements, fiber, myoinositol, and vitamins that may be effective in reducing the risk of GDM. The presented article is a narrative review. This article indicates that certain nutritional factors may have some benefit in preventing GDM. However, further studies in a variety of populations and large groups of patients are needed. At present, no definitive conclusions can be drawn as to the best intervention in the prevention of GDM.
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Is Supplementation with Micronutrients Still Necessary during Pregnancy? A Review.
Santander Ballestín, S, Giménez Campos, MI, Ballestín Ballestín, J, Luesma Bartolomé, MJ
Nutrients. 2021;(9)
Abstract
INTRODUCTION Proper nutrition during pregnancy is important to prevent nutritional imbalances that interfere with pregnancy. Micronutrients play critical roles in embryogenesis, fetal growth, and maternal health, as energy, protein, vitamin, and mineral needs can increase during pregnancy. Increased needs can be met by increasing the intake of dietary micronutrients. Severe micronutrient deficiency or excess during pregnancy can have negative effects on fetal growth (intrauterine growth retardation, low birth weight, or congenital malformations) and pregnancy development (pre-eclampsia or gestational diabetes). We investigate whether it is necessary to continue micronutrient supplementation during pregnancy to improve women's health in this stage and whether this supplementation could prevent and control pathologies associated with pregnancy. AIM: The present review aims to summarize evidence on the effects of nutritional deficiencies on maternal and newborn morbidity. METHODS This aim is addressed by critically reviewing results from published studies on supplementation with different nutrients during pregnancy. For this, major scientific databases, scientific texts, and official webpages have been consulted. PubMed searches using the terms "pregnancy" OR "maternal-fetal health" AND "vitamins" OR "minerals" OR "supplementation" AND "requirement" OR "deficiency nutrients" were performed. RESULTS There are accepted interventions during pregnancy, such as folic acid supplementation to prevent congenital neural tube defects, potassium iodide supplementation to correct neurodevelopment, and oral iron supplementation during the second half of pregnancy to reduce the risk of maternal anemia and iron deficiency. A number of micronutrients have also been associated with pre-eclampsia, gestational diabetes mellitus, and nausea and vomiting in pregnancy. In general, experimental studies are necessary to demonstrate the benefits of supplementation with different micronutrients and to adjust the recommended daily doses and the recommended periconceptional nutrition for mothers. CONCLUSIONS Presently, there is evidence of the benefits of micronutrient supplementation in perinatal results, but indiscriminate use is discouraged due to the fact that the side effects of excessive doses are not known. Evidence supports the idea that micronutrient deficiencies negatively affect maternal health and the outcome of pregnancy. No single micronutrient is responsible for the adverse effects; thus, supplementing or correcting one deficiency will not be very effective while other deficiencies exist.