scholarly journals Dietary Intervention in Pregnant Women with Gestational Diabetes; Protocol for the DiGest Randomised Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1165
Author(s):  
Laura C. Kusinski ◽  
Helen R. Murphy ◽  
Emanuella De Lucia Rolfe ◽  
Kirsten L. Rennie ◽  
Linda M. Oude Griep ◽  
...  
Keyword(s):  
Weight Gain ◽  
Caesarean Section ◽  
Gestational Diabetes ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Large For Gestational Age ◽  
Institute Of Medicine ◽  
Weight Changes ◽  
Maternal Weight ◽  
Double Blind

Gestational diabetes mellitus (GDM) annually affects 35,000 pregnancies in the United Kingdom, causing suboptimal health outcomes to the mother and child. Obesity and excessive gestational weight gain are risk factors for GDM. The Institute of Medicine recommends weight targets for women that are overweight and obese, however, there are no clear guidelines for women with GDM. Observational data suggest that modest weight loss (0.6–2 kg) after 28 weeks may reduce risk of caesarean section, large-for-gestational-age (LGA), and maternal postnatal glycaemia. This protocol for a multicentre randomised double-blind controlled trial aims to identify if a fully controlled reduced energy diet in GDM pregnancy improves infant birthweight and reduces maternal weight gain (primary outcomes). A total of 500 women with GDM (National Institute of Health and Care Excellence (NICE) 2015 criteria) and body mass index (BMI) ≥25 kg/m2 will be randomised to receive a standard (2000 kcal/day) or reduced energy (1200 kcal/day) diet box containing all meals and snacks from 28 weeks to delivery. Women and caregivers will be blinded to the allocations. Food diaries, continuous glucose monitoring, and anthropometry will measure dietary compliance, glucose levels, and weight changes. Women will receive standard antenatal GDM management (insulin/metformin) according to NICE guidelines. The secondary endpoints include caesarean section rates, LGA, and maternal postnatal glucose concentrations.

scholarly journals Calcium plus vitamin D supplementation affects pregnancy outcomes in gestational diabetes: randomized, double-blind, placebo-controlled trial

2015 ◽  
Vol 19 (1) ◽  
pp. 156-163 ◽  
Author(s):  
Maryam Karamali ◽  
Zatollah Asemi ◽  
Maedeh Ahmadi-Dastjerdi ◽  
Ahmad Esmaillzadeh
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Caesarean Section ◽  
Gestational Diabetes ◽  
Pregnancy Outcomes ◽  
Controlled Trial ◽  
Caesarean Section Rate ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Double Blind Placebo

AbstractObjectiveThe present study was designed to assess the effects of Ca+vitamin D supplementation on pregnancy outcomes in women with gestational diabetes mellitus (GDM).DesignA randomized, double-blind, placebo-controlled trial was conducted among sixty women with GDM. Participants were divided into two groups to receive Ca+vitamin D supplements or placebo. Individuals in the Ca+vitamin D group (n 30) received 1000 mg Ca/d and two pearls containing 1250 µg (50 000 IU) of cholecalciferol (vitamin D3) during the intervention (one at study baseline and another at day 21 of the intervention); those in the placebo group (n 30) received two placebos of vitamin D at the mentioned times and placebos of Ca every day for 6 weeks. Pregnancy outcomes were determined.SettingA urban community setting in Arak, Iran.SubjectsSixty women with GDM and their newborns, living in Arak, Iran were enrolled.ResultsWomen treated with Ca+vitamin D had a significant decrease in caesarean section rate (23·3 % v. 63·3 %, P=0·002) and maternal hospitalization (0 v. 13·3 %, P=0·03) compared with those receiving placebo. In addition, newborns of GDM women randomized to Ca+vitamin D had no case of macrosomia, while the prevalence of macrosomia among those randomized to placebo was 13·3 % (P=0·03). Lower rates of hyperbilirubinaemia (20·0 % v. 56·7 %, P=0·03) and hospitalization (20·0 % v. 56·7 %, P=0·03) were also seen in the supplemented group of newborns than in the placebo group.ConclusionsCa+vitamin D supplementation for 6 weeks among pregnant women with GDM led to decreased caesarean section rate and maternal hospitalization, and decreased macrosomia, hyperbilirubinaemia and hospitalization in newborns.

THE ASSOCIATION OF GESTATIONAL WEIGHT GAIN AND ADVERSE PREGNANCY OUTCOMES IN WOMEN WITH GESTATIONAL DIABETES MELLITUS

2019 ◽  
Vol 25 (11) ◽  
pp. 1137-1150 ◽  
Author(s):  
Qianyue Xu ◽  
Zhijuan Ge ◽  
Jun Hu ◽  
Shanmei Shen ◽  
Yan Bi ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Glucose Tolerance ◽  
Gestational Diabetes Mellitus ◽  
Gestational Weight Gain ◽  
Gestational Age ◽  
Large For Gestational Age ◽  
Institute Of Medicine ◽  
Gestational Weight

Objective: To explore the association of excessive gestational weight gain (GWG) defined by the Institute of Medicine (IOM) targets and adverse perinatal outcomes in gestational diabetes mellitus (GDM) pregnancies, and whether a modified target might be related to a lower rate of adverse perinatal outcomes for GDM. Methods: This retrospective cohort study involved 1,138 women of normal glucose tolerance (NGT) and 1,200 women with GDM. Based on the IOM target, pregnancies were classified to appropriate GWG (aGWG), inadequate GWG, and excessive GWG (eGWG). Modified GWG targets included: upper limit of IOM target minus 1 kg (IOM-1) or 2 kg (IOM-2), both upper and lower targets minus 1 kg (IOM-1-1) or 2 kg (IOM-2-2). Results: The proportions of women achieving eGWG were 26.3% in NGT and 31.2% in GDM ( P = .036); in comparison, for aGWG NGT, the risks of large for gestational age (LGA) were significantly higher in eGWG NGT (adjusted odds ratio [OR] 1.47; 95% confidence interval [CI] 1.02 to 2.13), aGWG GDM (adjusted OR 1.42; 95% CI 1.03 to 1.95), and eGWG GDM (adjusted OR 2.70; 95% CI 1.92 to 3.70). GDM pregnancies gaining aGWG based on the modified GWG targets (IOM-2, IOM-1-1, and IOM-2-2) had a lower prevalence of LGA and macrosomia delivery than that for similar pregnancies using the original IOM target (all P<.05). Conclusion: For aGWG GDM according to the IOM target, adhering to a more stringent weight control was associated with decreased adverse outcomes. A tighter IOM target might help to reduce the prevalence of adverse pregnancy outcomes. Abbreviations: aGWG = appropriate gestational weight gain; BG = blood glucose; BMI = body mass index; CI = confidence interval; eGWG = excessive gestational weight gain; GDM = gestational diabetes mellitus; GW = gestational weeks; GWG = gestational weight gain; HbA1c = hemoglobin A1c; iGWG = inadequate gestational weight gain; IOM = Institute of Medicine; LGA = large for gestational age; NGT = normal glucose tolerance; NICU = neonatal intensive care unit; OGTT = oral glucose tolerance test; OR = odds ratio; PARp = partial population attributable risks; SGA = small for gestational age

scholarly journals Antenatal Determinants of Childhood Obesity in High-Risk Offspring: Protocol for the DiGest Follow-Up Study

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1156
Author(s):  
Danielle Jones ◽  
Emanuella De Lucia Rolfe ◽  
Kirsten L. Rennie ◽  
Linda M. Oude Griep ◽  
Laura C. Kusinski ◽  
...  
Keyword(s):  
Childhood Obesity ◽  
Gestational Diabetes ◽  
Dietary Intervention ◽  
Controlled Trial ◽  
Large For Gestational Age ◽  
Postnatal Life ◽  
Follow Up Study ◽  
Calorie Diet ◽  
In Pregnancy

Childhood obesity is an area of intense concern internationally and is influenced by events during antenatal and postnatal life. Although pregnancy complications, such as gestational diabetes and large-for-gestational-age birthweight have been associated with increased obesity risk in offspring, very few successful interventions in pregnancy have been identified. We describe a study protocol to identify if a reduced calorie diet in pregnancy can reduce adiposity in children to 3 years of age. The dietary intervention in gestational diabetes (DiGest) study is a randomised, controlled trial of a reduced calorie diet provided by a whole-diet replacement in pregnant women with gestational diabetes. Women receive a weekly dietbox intervention from enrolment until delivery and are blinded to calorie allocation. This follow-up study will assess associations between a reduced calorie diet in pregnancy with offspring adiposity and maternal weight and glycaemia. Anthropometry will be performed in infants and mothers at 3 months, 1, 2 and 3 years post-birth. Glycaemia will be assessed using bloodspot C-peptide in infants and continuous glucose monitoring with HbA1c in mothers. Data regarding maternal glycaemia in pregnancy, maternal nutrition, infant birthweight, offspring feeding behaviour and milk composition will also be collected. The DiGest follow-up study is expected to take 5 years, with recruitment finishing in 2026.

Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Awathif Mackeen ◽  
Danielle Downs ◽  
Vonda Hetherington ◽  
Shawnee Lutcher ◽  
Jacob Mowery ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Usual Care ◽  
Gestational Weight Gain ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Household Food Security ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

scholarly journals Continued versus discontinued oxytocin stimulation in the active phase of labour (CONDISOX): double blind randomised controlled trial

BMJ ◽  
2021 ◽  
pp. n716
Author(s):  
Sidsel Boie ◽  
Julie Glavind ◽  
Niels Uldbjerg ◽  
Philip J Steer ◽  
Pinar Bor
Keyword(s):  
Caesarean Section ◽  
Fetal Heart Rate ◽  
Fetal Heart ◽  
Controlled Trial ◽  
Caesarean Section Rate ◽  
Active Phase ◽  
Double Blind ◽  
Oxytocin Infusion ◽  
Randomised Controlled ◽  
Reduced Risk

Abstract Objective To determine whether discontinuing oxytocin stimulation in the active phase of induced labour is associated with lower caesarean section rates. Design International multicentre, double blind, randomised controlled trial. Setting Nine hospitals in Denmark and one in the Netherlands between 8 April 2016 and 30 June 2020. Participants 1200 women stimulated with intravenous oxytocin infusion during the latent phase of induced labour. Intervention Women were randomly assigned to have their oxytocin stimulation discontinued or continued in the active phase of labour. Main outcome measure Delivery by caesarean section. Results A total of 607 women were assigned to discontinuation and 593 to continuation of the oxytocin infusion. The rates of caesarean section were 16.6% (n=101) in the discontinued group and 14.2% (n=84) in the continued group (relative risk 1.17, 95% confidence interval 0.90 to 1.53). In 94 parous women with no previous caesarean section, the caesarean section rate was 7.5% (11/147) in the discontinued group and 0.6% (1/155) in the continued group (relative risk 11.6, 1.15 to 88.7). Discontinuation was associated with longer duration of labour (median from randomisation to delivery 282 v 201 min; P<0.001), a reduced risk of hyperstimulation (20/546 (3.7%) v 70/541 (12.9%); P<0.001), and a reduced risk of fetal heart rate abnormalities (153/548 (27.9%) v 219/537 (40.8%); P<0.001) but rates of other adverse maternal and neonatal outcomes were similar between groups. Conclusions In a setting where monitoring of the fetal condition and the uterine contractions can be guaranteed, routine discontinuation of oxytocin stimulation may lead to a small increase in caesarean section rate but a significantly reduced risk of uterine hyperstimulation and abnormal fetal heart rate patterns. Trial registration ClinicalTrials.gov NCT02553226 .

scholarly journals Contributing Factors to Perinatal Outcome in Pregnancies with Gestational Diabetes—What Matters Most? A Retrospective Analysis

2021 ◽  
Vol 10 (2) ◽  
pp. 348
Author(s):  
Friederike Weschenfelder ◽  
Friederike Hein ◽  
Thomas Lehmann ◽  
Ekkehard Schleußner ◽  
Tanja Groten
Keyword(s):  
Weight Gain ◽  
Gestational Diabetes ◽  
Perinatal Outcome ◽  
Perinatal Outcomes ◽  
Large For Gestational Age ◽  
Obese Women ◽  
Patient Counseling ◽  
Contributing Factors ◽  
Prepregnancy Bmi ◽  
The Impact

The aim of diabetes care of pregnant women with gestational diabetes mellitus (GDM) is to attain pregnancy outcomes including rates of large-for-gestational-age (LGA) newborns, pre-eclampsia, C-sections (CS) and other neonatal outcomes similar to those of the non-GDM pregnant population. Obesity and excessive weight gain during pregnancy have been shown to also impact perinatal outcome. Since GDM is frequently associated with elevated body mass index (BMI), we evaluated the impact of maternal prepregnancy BMI, development of GDM and gestational weight gain (GWG) during pregnancy on perinatal outcome. We compared 614 GDM patients with 5175 non-diabetic term deliveries who gave birth between 2012 and 2016. Multivariate regression analysis was used to evaluate the independent contribution of each factor on selected perinatal outcome variables. Additionally, subgroup analysis for obese (BMI ≥ 30 kg/m2) and non-obese women (BMI < 30 kg/m2) was performed. LGA was significantly influenced by BMI, GWG and GDM, while Neonatal Intensive Care Unit (NICU) admission was solely impacted by GDM. Maternal outcomes were not dependent on GDM but on GWG and prepregnancy BMI. These results remained significant in the non-obese subgroup only. Thus, GDM still affects perinatal outcomes and requires further improvement in diabetic care and patient counseling.

scholarly journals The effects of synbiotic supplementation on markers of insulin metabolism and lipid profiles in gestational diabetes: a randomised, double-blind, placebo-controlled trial

2016 ◽  
Vol 116 (8) ◽  
pp. 1394-1401 ◽  
Author(s):  
Shahnaz Ahmadi ◽  
Mehri Jamilian ◽  
Maryam Tajabadi-Ebrahimi ◽  
Parvaneh Jafari ◽  
Zatollah Asemi
Keyword(s):  
Gestational Diabetes ◽  
Controlled Trial ◽  
Lipid Profiles ◽  
Model Assessment ◽  
Double Blind ◽  
Insulin Metabolism ◽  
Double Blind Placebo ◽  
Vldl Cholesterol ◽  
Freeze Dried ◽  
Synbiotic Supplementation

AbstractTo the best of our knowledge, data on the effects of synbiotic supplementation on markers of insulin metabolism and lipid concentrations in patients with gestational diabetes mellitus (GDM) are scarce. The aim of the current study was to determine the effects of synbiotic supplementation on markers of insulin metabolism and lipid profiles in GDM patients. In total, seventy patients with GDM aged 18–40 years were assigned to two groups – the synbiotic group (n 35) and the placebo group (n 35) – in this randomised, double-blind, placebo-controlled trial. Patients in the synbiotic group received a daily capsule that contained three viable and freeze-dried strains: Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium bifidum (2×109 colony-forming units/g each) plus 800 mg inulin for 6 weeks. Fasting blood samples were collected at the beginning and week 6 to quantify related markers. After 6 weeks of intervention, compared with the placebo, synbiotic supplementation led to a significant decrease in serum insulin levels (−1·5 (sd 5·9) v. +4·8 (sd 11·5) µIU/ml, P=0·005), homoeostatic model assessment for insulin resistance (−0·4 (sd 1·3) v. +1·1 (sd 2·7), P=0·003) and homoeostatic model assessment for β cell function (−5·1 (sd 24·2) v. +18·9 (sd 45·6), P=0·008) and a significant increase in quantitative insulin sensitivity check index (+0·01 (sd 0·01) v. −0·007 (sd 0·02), P=0·02). In addition, synbiotic intake significantly decreased serum TAG (−14·8 (sd 56·5) v. +30·4 (sd 37·8) mg/dl, P<0·001) and VLDL-cholesterol concentrations (−3·0 (sd 11·3) v. +6·1 (sd 7·6) mg/dl, P<0·001) compared with the placebo. Overall, the results of this study demonstrate that taking synbiotic supplements for 6 weeks among patients with GDM had beneficial effects on markers of insulin metabolism, TAG and VLDL-cholesterol concentrations.

Sign in / Sign up

Export Citation Format

Share Document