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Pregnancy in Diabetics clinical trials

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NCT ID: NCT03229161 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Interval Walking Intervention for Pregnant Women Diagnosed With Gestational Diabetes Mellitus

Start date: January 3, 2017
Phase: N/A
Study type: Interventional

It is well-known that regular physical activity (PA) can improve glycemic control and physical fitness in type 2 diabetes patients. However, studies examining the effects of PA in patients with gestational diabetes mellitus (GDM) are limited. Interval walking training (IWT) is a careful type of PA consisting of repeatedly cycles of 3 min. fast and slow walking. The investigators aimed to examine, if IWT is feasible as PA intervention for GDM patients, and to examine the effects of IWT on glycemic control, PA levels and physical fitness.

NCT ID: NCT03169205 Enrolling by invitation - Clinical trials for Pregnancy in Diabetics

Diabetes Mellitus With Pregnancy in Benisuef Localities

Start date: May 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal & fetal complications and to predict the risk factors for poor maternal, fetal & neonatal outcomes

NCT ID: NCT03106870 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Start date: June 2016
Phase: N/A
Study type: Interventional

The purpose of the study to prove benefits of adding metformin to insulin for controlling presentational and gestational diabetes mellitus and improving neonatal outcome.

NCT ID: NCT03067662 Recruiting - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Aerobic Exercise in Women With Gestational Diabetes

GDM-FIT
Start date: September 27, 2012
Phase: N/A
Study type: Interventional

A few, small randomized controlled trials have investigated the effects of exercise on blood glucose levels in women with gestational diabetes (GDM), with inconsistent results. To assess the effects of supervised exercise in women with GDM, 48 women with gestational diabetes, diagnosed between the 18th and 28th week of gestation, will be recruited, after exclusion of subjects with contraindications to exercise. These subjects will be randomly assigned to two groups: structured exercise intervention or standard care. Women in the intervention group will perform low intensity aerobic exercise three times per week at 30% HRR (heart rate reserve), under continuous heart rate monitoring. Duration of each session will progress from 26 minutes the first week to 40 minutes (increasing 2 min/week). Women in the control group will receive standard diet and physical exercise recommendations. In all women, clinical, metabolic and anthropometric features will be assessed before, during and at the end of the study. Newborn data will also be collected.

NCT ID: NCT03029702 Completed - Clinical trials for Gestational Diabetes

Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

MATCh-GDM
Start date: February 28, 2018
Phase: Phase 4
Study type: Interventional

Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over 400,000 pregnant women in the United States each year. Without adequate treatment, women with GDM and their infants are at risk for substantial morbidity. Because of this, experts recommend treatment focused on normalization of hyperglycemia to improve outcomes. However, providers have limited capacity to predict which treatment will achieve glycemic goals. This results in a choice based on provider and patient preference and a trial and error approach, which can create delays in glycemic control within the short (8-10 weeks) window between diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use of an individualized treatment approach. The overall goal of this project is to investigate an individualized treatment approach for GDM where treatment is based on each woman's GDM mechanism. The study will employ the same treatment in both arms, but choice of treatment will differ based on study arm (matched or unmatched to GDM mechanism).

NCT ID: NCT03028506 Completed - Clinical trials for Diabetes in Pregnancy

Meal Composition and the Influence on Pre-prandial Blood Glucose Values

Start date: January 2015
Phase: N/A
Study type: Observational

The purpose of the proposed study is to assess the distribution of carbohydrates and fat in the diet of women with type 1 diabetes during pregnancy. More specifically, it will look at the distribution of carbohydrate in the diet during weeks 29-32 of pregnancy. The carbohydrate distribution and fat content of the meal will be compared to maternal glucose control, preprandial glucose levels, and the percentile for weight of the infant at birth. In addition, each meal and snack will be classified as low-moderate fat or high fat.

NCT ID: NCT02979756 Completed - Clinical trials for Gestational Diabetes Mellitus in Pregnancy

Improve Detection and Management of Gestational Diabetes Through the Primary Health Care Level in Morocco

Start date: November 14, 2016
Phase: N/A
Study type: Interventional

A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in receiving appropriate care. Based on the results of the situational analysis, the investigators developed this proposal in close collaboration with the Moroccan research group on gestational diabetes composed of representatives of the Ministry of Health, researchers, members of professional organizations and specialists in the domains of endocrinology, gynecology, neonatal health and nutrition. The investigators opted for an hybrid implementation effectiveness trial to evaluate both clinical effectiveness of the proposed screening and initial management strategy and its implementation at the first level of care. The objectives of this study are thus to evaluate the feasibility of a decentralized strategy of screening for GDM and the initialization of GDM treatment already through the primary level of care and to assess its potential for scaling-up. Specific objectives of this study are to augment universal access to screening and management of gestational diabetes and to increase the competencies of health care providers at first level health care facilities to detect, start initial treatment and to improve follow-up of affected women. By comparing active screening and treatment initiation through first line health facilities with the existing practices, the investigators would like to explore the effect of the new model on maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery complications and birth weight. The investigators will further assess the acceptability of screening and initial management of GDM through first line health services by health care providers and by pregnant women diagnosed with GDM and the impact of two different screening approaches on the lifestyle of affected mothers.

NCT ID: NCT02968628 Completed - Clinical trials for Diabetes, Gestational

Effect of Maternal Diabetes on Brain Development, as Measured by Neonatal Electroencephalogram (EEG)

Start date: September 1, 2016
Phase:
Study type: Observational

Alterations in the intrauterine environment can have profound effects on fetal development. Diabetes during gestation results in multiple deleterious short-term outcome differences, and is correlated with long-term developmental deficits. Multiple studies, in neonates through school-aged children, have demonstrated differences in language, attention and psychomotor development in offspring of diabetic pregnancies. Neonatal EEG is a promising and non-invasive tool for assessment of abnormal brain development or "dysmaturity" in this population. Multiple conventional EEG (cEEG) and amplitude-integrated EEG (aEEG) parameters change predictably with advancing gestational development and have been used to differentiate between at risk groups in neonatal studies. The investigators hypothesize that neonatal EEG can identify brain dysmaturity in infants of diabetic mothers (IDMs) compared to gestational-age matched controls. The primary aim is documentation of brain dysmaturity in IDMs using cEEG. The secondary aim is establishment of aEEG as a more accessible tool to quantify the effects of maternal diabetes on neonatal brain development. The investigators will conduct a pilot study comparing cEEG and aEEG parameters of cases to gestational-age matched controls. Cases will be IDM neonates of at least 35 weeks' gestation whose mothers were recommended treatment with either insulin or an oral glycemic agent. Video EEG recording will be planned for approximately 60 minutes and obtained between 24 hours and 5 days of life during birth hospitalization. Additional data will be extracted from maternal and neonatal medical records and a maternal questionnaire. In addition to evaluating the measures of cEEG and aEEG, this project will establish a research cohort. A subsequent study involving developmental evaluations will allow for correlation of EEG results with long-term outcomes. The ability to identify those at risk at birth would provide the opportunity to intervene in order to mitigate outcome differences, particularly in language development. More significantly, we hope to establish neonatal CNS outcome measures for future diabetic pregnancy intervention studies. .

NCT ID: NCT02890836 Completed - Clinical trials for Pregnancy in Diabetics

Blood Pressure, Antihypertensive Treatment and Preeclampsia in Pregnant Wom-en With Pre-existing Diabetes

Start date: February 2016
Phase:
Study type: Observational

Aim: First, to investigate the prevalence of a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure in pregnant women with pre-existing diabetes. Second, to explore the prevalence of preeclampsia and preterm delivery in women with pre-existing diabetes with a) confirmed hypertension, b) white coat hypertension and c) normal blood pressure before entering the third trimester of pregnancy. Third, to explore the influence of lifestyle, gestational weight gain and mental well-being on confirmed hypertension and preeclampsia in pregnant women with diabetes.The recruitment period was in 2018 extended to 2020 to perform the following studies: First whether home BP in early pregnancy is superior to office BP to predict preeclampsia. Second to evaluate the prevalence of preeclampsia after initiation of a new treatment strategy including prophylactic aspirin and, in case of insufficiency, vitamin D supplementation. Design: A prospective multicentre observational study where approximately 400 pregnant women with pre-existing diabetes are offered measurements of office blood pressure (BP) and home BP for three days three times during pregnancy as well as when the routinely measured office BP exceeds 135/85 mmHg. The prevalence of confirmed hypertension (office BP >135/85 mmHg and home BP >130/80 mmHg) and white coat hypertension (office BP >135/85 mmHg but home BP ≤130/80 mmHg) will be determined. Women with confirmed hypertension are offered antihypertensive treatment mainly with methyldopa. In women with a) confirmed hypertension, b) white coat hypertension, and c) normal blood pressure before entering third trimester of pregnancy, the prevalence of preeclampsia and preterm delivery will be evaluated. Possible side effects of antihypertensive treatment including impaired fetal haemodynamics and lower infant birth weight will be recorded. The women will complete food diaries and questionnaires on lifestyle and mental health three times in pregnancy in order to evaluate the influence of these parameters on hypertension and preeclampsia.

NCT ID: NCT02768818 Recruiting - Clinical trials for Dietary Modification

Modulation of the Intestinal Flora With the Probiotic VIVOMIXX™ in Pregnant Women at Risk of Metabolic Complications

Start date: January 2016
Phase: Phase 3
Study type: Interventional

The investigators aimed at evaluating the effectiveness of probiotics ingestion in changing maternal microbiota and preventing gestational diabetes in overweight and obese women. To achieve these goals, obese (BMI> 30 kg/m^2) or overweight (BMI> 25 kg/m^2) pregnant women with risk factors were enrolled in the study and randomized to the supplementation with the probiotic VIVOMIXX® or with placebo. The endpoints of this study are to evaluate if the dietary supplementation with the probiotic VIVOMIXX® modifies the maternal fecal microbiota (bifidobacteria and lactobacilli) and related enzymatic activity (alkaline sphingomyelinase and alkaline phosphatase), and if this if this is linked to an improvement of the intermediate metabolism (positive Oral Glucose Tolerance Test at 24-26 weeks).