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NCT05843175
Poor glycaemic control in pregnancy is a major factor leading to obstetric complications and future maternal-offspring diseases. This phenomenon is evidenced in women with type 1 diabetes (T1DM), and is worrisome since it is aggravating the disease burden of this and next generations. Exercise is a promising tool to improve glucose control during pregnancy and thus avoid adverse consequences. The MERIT1D study will explore when is exercise (before or after lunch) more effective to improve postprandial glycaemic control in pregnant and non-pregnant women (of reproductive age) with T1DM, and the mechanisms underlying these metabolic responses.
NCT06343974
The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls. The main questions it aims to answer are: * Are fetal liver ultrasound radiomic features reproducible? * Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls? Participants will undergo ultrasound examination to collect ultrasound data for the analyses.
NCT05909046
DIP : To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM. Follow up PP CARE: To engage with individuals with a history of GDM through a patient-centered mixed-methods survey and qualitative assessment to evaluate the barriers to and facilitators of Cardiovascular health (CVH) counseling and risk-reduction postpartum at the patient and healthcare system levels inclusive of Social determinants of health (SDOH) and structural factors, as well as patient preferences and perspectives on CVH and wellness interventions
NCT06963528
The primary goal is to predict the clinical outcomes of mother and baby using blood glucose and other routinely collected clinical data in pregnancy to predict adverse outcomes at birth in women with GDM. The secondary goal is to develop models to predict optimal blood glucose testing schedules for pregnant women. Exploratory Objectives are (1) to understand patterns of dosage and / or medication choice and (2) to describe different phenotypes of gestational diabetes based on multiple data input.
NCT06959316
T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.
NCT04060056
The Westlake Precision Birth Cohort (WeBirth) is a prospective cohort study among women with hyperglycemia during pregnancy and their offspring living in Hangzhou, China. The primary aim of this cohort is to characterize the continuous blood glucose response to dietary intake and physical activity among pregnant women with gestational diabetes mellitus (GDM) over 2 weeks, and to facilitate the development of personalized nutritional/lifestyle recommendation among these patients. Another aim of WeBirth is to investigate the association of dietary intake and physical activity together with continuous glucose change during pregnancy on the adverse birth outcomes including preterm birth, macrosomia and large-for-gestational-age birth. The secondary aim is to investigate the prospective associations of diet, physical activity and continuous glucose change over 2 weeks among the participants with long-term metabolic health of these women and their offspring.
NCT05370612
This study will assess differences in patient preferences and glucose control between continuous glucose monitoring and standard glucose checks in pregnant patients with Type 2 Diabetes. 40 participants will be on study for approximately 182 days (26 weeks).
NCT04433364
Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2. Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood. Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires as well as in form of interviews. Conclusion: This project will help obstetricians and neonatologists better recognize clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies alongside providing right level of surveillance and management during pregnancy, delivery, and child health care.
NCT05678543
Pregnancies in women with pre-existing diabetes are considered "high risk" pregnancies, poses daily clinical challenges and in terms of research - a number of unanswered questions. Therefore, the investigators wish to establish a nationwide cohort of pregnancies complicated by pre-existing diabetes - the Danish Diabetes Birth Registry (DDBR2) The DDBR2 registry comprises all types of pre-existing diabetes including T1D, T2D and other types (as MODY), generating a nationwide cohort of mother/partner/children trios with accessible registry-, clinical data and biological biobank samples. This will enable the investigators to use data longitudinally to examine short- and long-term outcomes of pregnancies in women with diabetes.
NCT03761615
The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow their glycemic outcomes prospectively throughout pregnancy and into the post-partum period. The investigators anticipate that when compared to subjects using an Artificial pancreas system (AP) as part of a future protocol, this comparator group of subjects undergoing usual care will exhibit less time in target continuous glucose monitoring (CGM) glucose range defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose \<63 mg/dL.
NCT06228313
Rationale: Most BGM (blood glucose monitoring) devices in Vietnam are manufactured for home use only. However, they are commonly used in healthcare facility, primarily at point of care. We want to assess the validity of these devices by using CLSI (Clinical and Laboratory Standards Institute) POCT12-A3 to assess the accuracy. Objective: To validate the accuracy and effect of hematocrit on these devices, along with the precision profile using CLSI EP15A3 Study design: This is a cross-sectional study. Study population: Because we need a wide range of blood glucose level. We chose pregnant women who underwent 75g glucose tolerance test.
NCT05025852
The incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. Metformin is used for type 2 diabetes (T2DM) outside of pregnancy and is now increasingly prescribed during pregnancy. There are some concerns as metformin crosses the placenta and effects on offspring exposed during pregnancy are unknown. Animal and human evidence indicate that metformin may create an atypical in-utero environment similar to under-nutrition which has been associated with adult obesity. This is supported by studies in children of mothers treated with metformin in other populations where an increase in childhood obesity was found at 4-9 years of age. We now have evidence from the MiTy trial, that offspring of metformin-exposed women with T2DM have less large infants and are less adipose at birth, but are also more likely to be small for gestational age (SGA). These effects could lead to benefit or harm in the long-term. Offspring of MiTy mothers are currently being followed up to 2 years. Given that long-term effects may not be evident until 5 years of age, it is imperative to follow these children longer. Goals/Research Aims:To determine whether in-utero exposure to metformin, in offspring of women with T2DM, is beneficial or harmful in the long-term. Research Questions: 1. In offspring of women with T2DM, how does treatment with metformin during pregnancy affect a) adiposity b) growth over time c) metabolic syndrome d) cognitive and behavioral measures:2. What factors predict altered childhood adiposity and insulin resistance in these offspring? Primary Outcome: Body mass index (BMI) z-score. Secondary Outcomes: 1) other measures of adiposity (i.e. skinfolds, 2) growth over time 3) measures of insulin resistance 4) adipocytokines 5)neurodevelopment Expected Outcomes Given these increasing concerns, this study will inform the best treatment for pregnant mothers with diabetes by studying the long-term outcomes of children exposed to metformin during pregnancy.
NCT03240289
Diabetes during pregnancy can be a challenging circumstance requiring extensive patient learning and self-care. The purpose of this study is to develop and pilot test a patient-centered diabetes education and self-care tool using text messaging to provide supportive messaging and education to underserved women with a pregnancy complicated by diabetes.
NCT03273881
This study aims to examine the effect of intrapartum treatment of diabetic women with combined glucose and constant insulin infusion compared to glucose alone on the incidence of neonatal hypoglycemia. Pregnant women with diabetes in pregnancy will be randomly divided during labor to 2 groups: group 1, will receive intravenous glucose with constant insulin infusion; group 2 will receive intravenous glucose alone. The primary outcome is the incidence of neonatal hypoglycemia.
NCT06002997
The results of contemporary studies suggest an association between inflammatory periodontal disease and pregnancy and delivery complications. The aim of this study was to assess the association between periodontal disease, clinical periodontal parameters and pregnancy or delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women.
NCT04547023
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. The investigators plan to conduct a prospective randomized trial comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed state on routine gestational diabetes screening results.
NCT04801121
Diabetic pregnancies are often complicated by placental dysfunction with reduced transfer of oxygen from the mother to the fetus, which may compromise fetal growth and organ development. In diabetic pregnancies, hyperinsulinemia and hyperglycemia very often leads to fetal macrosomia. The combination of reduced placental oxygen transfer and increasing fetal demand due to fetal overgrowth may possess a particular risk of adverse pregnancy outcome. Current methods in the antenatal identification of placental dysfunction relies on estimates of fetal size and fetal wellbeing using ultrasound including Doppler flows measurements. These measurements are only indirect estimates of placental function, as no clinical method exists to assess placental function directly. In diabetic pregnancies, the estimates are further limited due to fetal overgrowth and unreliable Doppler. In addition, in diabetic pregnancies, intrauterine fetal weight estimates by ultrasound are inaccurate because of asymmetric fetal growth. Therefore, new accurate methods to assess placental function, fetal oxygenation and fetal growth in this particular group of high-risk pregnancies is highly needed. Early and precise identification of pathology in diabetes pregnancy may lead to an improved outcome in the offspring, as precise identification of pathology facilitates important obstetric decisions in regards to maternal antidiabetic treatment and timing of delivery. Resent research indicates that MRI is useful for this purpose. It is well described, that preeclampsia is associated with an increased maternal risk of cardiovascular disease later in life. Recent studies suggest, that pregestational subclinical cardiovascular dysfunction, in particular left ventricular dysfunction, may increase the risk of preeclampsia and fetal growth restriction during pregnancy. Cardiac MRI is a sensitive method to detect subclinical maternal cardiac dysfunction, which may be used in identification of high-risk pregnancies. In addition, the longitudinal design of this study allows for the investigation of cardiovascular changes during pregnancies in normal pregnancies and pregnancies complicated by diabetes. The overall aim of this study is to improve the antenatal fetal and maternal monitoring in diabetes pregnancies. Early and precise identification of pregnancy pathology provides a better basis for important obstetric decisions regarding antidiabetic treatment, monitoring intervals and timing of delivery, which leads to a better outcome for the mother and offspring. Hypothesis Project A: Placental function and fetal oxygenation in diabetic pregnancies estimated by T2\* weighted placental and fetal MRI Aim: To investigate placental function and fetal oxygenation by longitudinal T2\* weighted placental MRI and the association with pregnancy complications. Hypothesis: * Diabetic pregnancies are characterized by placental hypoxia (low T2\* value) * Diabetic pregnancies are characterized by fetal hypoxia (low T2\* value) * Fetal and placental hypoxia is a risk factor of placental related complications in pregnancy such as low birth weight, preterm delivery, acute cesarean sections and preeclampsia. Project B: Fetal growth and the growth of selected fetal organs in diabetic pregnancies estimated by longitudinal MRI volumetry Aim: To investigate growth velocity of the fetus and selected fetal organs and the correlation with pregnancy complications. Hypothesis: * Diabetic pregnancies are characterized by accelerated fetal growth in the third trimester * Diabetic pregnancies are characterized by asymmetric growth (reduced brain/liver-volume ratio) * Abnormal fetal growth is associated with dysregulated maternal diabetes. * Abnormal fetal growth is a risk factor of pregnancy complications such as; macrosomia, preterm delivery and acute cesarean sections. Project C: Maternal cardiac function in diabetic pregnancies estimated by MRI Aim: To investigate maternal cardiac function and the correlation with pregnancy complications such as preeclampsia and fetal growth restriction. Hypothesis: * Maternal cardiac function is altered in diabetes pregnancies when compared to normal pregnancies. * Impaired cardiac function (left ventricular dysfunction) is a risk factor of preeclampsia and fetal growth restriction.
NCT04862390
The physiological change in food and sleep pattern during Ramadan impacted hypoglycemia risks among pregnant women. Few studies investigated the incidence of hypoglycemia pregnant women with or without diabetes during fasting in Ramadan in Saudi Arabia. This study aims to understand the glucose variability in pregnant women during fasting Ramadan in Saudi Arabia.
NCT04206748
The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT
NCT04924738
This prospective observational trial includes women with high risk pregnancies complicated with hyperglycemia in pregnancy and excessive body weight. The participants are enrolled when pregnant and monitored throughout pregnancy and delivery until the offspring is 6 months old. This research addresses the question which risk factors for non-communicable disorders such as hypertension, obesity, type 2 diabetes for a woman and her offspring can be detected during pregnancy and in early childhood.