Clinical Research Directory

Gastric Ultrasound After Clear Fluid Intake in Diabetic and Non-Diabetic Pregnant Women

Pulmonary aspiration of gastric contents during anesthesia is a serious perioperative complication associated with significant morbidity and mortality. Pregnant women are at increased risk of aspiration because of physiological changes such as delayed gastric emptying and increased intra-abdominal pressure. In addition, gestational diabetes mellitus (GDM) may affect gastric motility and gastric emptying. Current fasting guidelines allow the intake of clear fluids up to two hours before anesthesia. However, the effect of preoperative oral clear fluid intake on gastric volume in pregnant women with GDM remains unclear. This prospective interventional study compares gastric volume measured by gastric ultrasonography in term pregnant women with and without gestational diabetes mellitus (GDM) undergoing elective cesarean delivery. Participants receive 200 mL of oral water after baseline gastric ultrasonography. Gastric ultrasonography is performed before water intake (T1), immediately after completion of water intake (T2), and two hours after water intake immediately before anesthesia (T3) to evaluate gastric volume and gastric content. The study aims to improve the assessment of gastric volume and perioperative fasting in pregnant women, particularly those with gestational diabetes mellitus.

Diabetes, Insulin, Gut, Enteric Supplementation Trial

Pregnancy is a critical window for metabolic health, and early changes in blood sugar regulation can increase the risk of gestational diabetes mellitus (GDM), which affects both maternal and infant health. At the same time, the maternal gut microbiome changes throughout pregnancy and may play a role in glucose metabolism and insulin resistance. Kefir, a fermented milk drink containing beneficial bacteria and yeasts, may be a simple dietary strategy to support metabolic health during pregnancy, but its role in preventing GDM has not been well studied. This study will test whether drinking kefir daily from mid-pregnancy until routine GDM screening can improve glucose and insulin regulation, reduce the incidence of GDM, and modulate the maternal gut microbiome and metabolites, among other outcomes. Pregnant individuals will be randomly assigned to either a kefir group or a control group receiving usual prenatal care. Researchers will collect blood glucose and insulin measures, dietary information, stool samples, and body composition data across pregnancy and postpartum to evaluate metabolic and microbiome-related changes. As one of the first studies to examine kefir as an early pregnancy intervention for GDM prevention, this study will help clarify whether a practical, food-based approach can improve maternal metabolic health. The findings may support future nutrition strategies aimed at reducing GDM risk and improving pregnancy outcomes.

Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus

This is an effectiveness-implementation Hybrid Type 1 study using a randomized clinical trial design to evaluate the effectiveness and potential real-world integration of immediate postpartum semaglutide following a pregnancy complicated by gestational diabetes mellitus (GDM). A total of 226 postpartum individuals with recent GDM will be randomized 1:1 to semaglutide or standard postpartum care for a 6-month active treatment phase. The primary effectiveness outcome, development of metabolic syndrome, will be assessed at 6 months postpartum. Participants will subsequently enter a 6-month maintenance phase, during which semaglutide continuation, discontinuation, or initiation will reflect patient preferences, clinical decision-making, medication access, and insurance coverage.

The WAIT Trial: Waiting Versus Active Induction at Term in Women With A1 Gestational Diabetes Mellitus

This multicenter, open-label, superiority randomized controlled trial will evaluate whether delaying planned induction from 40 weeks to 41 weeks improves delivery outcomes in women with A1 gestational diabetes mellitus (A1 GDM). The study is designed to enroll 1,500 eligible women (750 per group), all of whom are planned for vaginal delivery. Eligible participants are women aged 18-40 years with singleton pregnancy and who are primiparous. GDM will be diagnosed using OGTT at 24-28 weeks, and participants must meet criteria for A1 GDM, meaning blood glucose is controlled with diet and exercise only (no insulin or other glucose-lowering medications during pregnancy). After providing written informed consent, participants will be randomized 1:1 to one of two pre-specified induction strategies. Control group (planned induction at 40 weeks): Participants will have planned induction at 40+0 weeks (time window 39+6 to 40+0). If spontaneous labor occurs before or during the window, obstetric management will follow routine clinical practice. If labor has not started by the end of the window, induction will be performed according to the protocol. Intervention group (expectant management until 41 weeks): Participants will be managed expectantly until 41+0 weeks with planned induction in the 41+0 to 41+1 weeks window. If spontaneous labor occurs before or during the window, routine obstetric management will be used. If labor has not started by the end of the window, induction will be performed according to the protocol. Participants will be followed from randomization until delivery and hospital discharge, with selected outcomes followed up to postpartum day 42. The primary outcome is the cesarean delivery rate. Secondary outcomes include maternal outcomes such as postpartum hemorrhage and other obstetric complications, neonatal/perinatal outcomes including perinatal death, and need for respiratory support, as well as selected health-economic and patient-reported outcomes. All participating centers will apply standardized procedures for screening, monitoring, induction methods, and data collection. An independent Data and Safety Monitoring Board (DSMB) and a blinded Clinical Endpoint Committee will monitor safety and validate the primary outcome. The trial is expected to be completed within approximately 18 months after initiation of recruitment, and the results will provide high-quality evidence to inform timing of delivery for women with A1 GDM in China.

The Role of Hormonal and Metabolic Disorders in the Debelopment of Gestational Diabetes Mellitus

The work was carried out at the V. P. Demikhov City Clinical Hospital, a clinical base of the Department, and consisted of two consecutive stages, during which clinical material was collected between 2019 and 2021≥5.1mmol/L, but \< 7.0 mmol/L, or when performing OGTT with 75 g of glucose during pregnancy at 24-28 weeks (after 1 hour ≥10.0 mmol/l and/or after 2 hours ≥8.5, but \< 11.1 mmol/l). The 1st group consisted of 359 pregnant women who were diagnosed with GDM as part of the 1st stage of the disease screening (gestational age less than 24 weeks). The 2nd group included 151 pregnant women who were diagnosed with GDM as part of the 2nd stage of the disease screening (24 weeks of gestation or more). To assess the dynamics of anthropometric indicators, the following were studied: body weight, height, BMI at the time of registration at the women's consultation, and gestational weight gain over the entire period of pregnancy. To assess the characteristics of the glycemic profile and calculate the parameters of glycemic variability, pregnant women underwent glycemic monitoring using the FreeStyle Libre Flash system (Abbott Diabetes Care, Witney,United Kingdom)current pregnancy Diagnosis of GDM (O24.4) was carried out in accordance with the criteria regulated by domestic clinical guidelines. The diagnostic threshold for GDM was an increase in fasting blood glucose levels ≥5.1mmol/L, but \< 7.0 mmol/L, or when performing OGTT with 75 g of glucose during pregnancy at 24-28 weeks (after 1 hour ≥10.0 mmol/l and/or after 2 hours ≥8.5, but \< 11.1 mmol/l). Individual outpatient records, data from instrumental and laboratory studies, and birth histories of pregnant women with GDM, as well as the development history of newborns born to mothers with GDM. The main risk factors for the development of GDM (age, parity of childbirth, heredity, GDM and its indirect signs in the medical history, obesity, gestational weight gain (GWG); 40 gestational age and venous plasma glucose level at the time of diagnosis GDM; methods of GDM treatment (diet therapy/insulin therapy); complications of the current pregnancy (fetoplacental insufficiency (FPI), preeclampsia, eclampsia, threat of pregnancy termination, threat of premature birth, polyhydramnios, oligohydramnios). 213 women with GDM from the total analyzed group were delivered at the maternity hospital No. 8 in 2019-2020. Based on the birth histories and development histories of newborns from this group, the main outcomes of pregnancy, the frequency of complications during childbirth on the part of the mother and the fetus (macrosomia, birth trauma, fetal respiratory distress syndrome, weakness of labor activity, premature birth, premature rupture of membranes (PROM), congenital malformations, etc.), were evaluated. The postpartum glycemic levels of women with GDM and newborns were assessed. The clinical and anamnestic features and risk factors for the development of adverse outcomes in GDM were established. To assess the risk factors for the development of perinatal complications in GDM, as well as the impact of its course and treatment on the development of perinatal pathology, all pregnant women were divided into two groups based on the gestational age at which GDM was detected. The 1st group consisted of 359 pregnant women who were diagnosed with GDM as part of the 1st stage of the disease screening (gestational age less than 24 weeks). The 2nd group included 151 pregnant women who were diagnosed with GDM as part of the 2nd stage of the disease screening (24 weeks of gestation or more). At the 2nd stage of the study, a prospective non-interventional observational study was conducted to identify the etiopathogenetic mechanisms of the development of GDM and to determine the clinical and laboratory markers of the formation of adverse perinatal outcomes. For this purpose, a new study group was formed using a random sample method, which included 91 pregnant women with a confirmed diagnosis of GSD at different stages of gestation, and they were monitored dynamically.

Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes

Gestational diabetes mellitus (GDM) is a type of diabetes that is first diagnosed during pregnancy. It causes high blood sugar levels and can increase the risk of health problems for both the mother and the baby. Babies may grow larger than expected (macrosomia), which can make delivery more difficult and increase the risk of birth complications. Mothers with GDM are also more likely to need insulin treatment and may have a higher risk of high blood pressure during pregnancy. Good blood sugar control is important to reduce these risks. The usual way to monitor blood sugar in women with GDM is by self-monitoring of blood glucose (SMBG). This involves pricking the finger several times a day to measure blood sugar levels. Although this method provides useful information, it only shows glucose levels at specific moments and may miss changes that happen during the night or between measurements. Continuous glucose monitoring (CGM) is a newer method that uses a small sensor placed under the skin to measure glucose levels throughout the day and night. It provides more detailed information about blood sugar patterns and does not require frequent finger pricks. CGM has been shown to improve blood sugar control in people with type 1 and type 2 diabetes, but its benefits in women with gestational diabetes are not yet fully known. The purpose of this study is to compare continuous glucose monitoring (CGM) with standard finger-prick monitoring (SMBG) in pregnant women diagnosed with gestational diabetes between 24 and 28 weeks of pregnancy. The study will evaluate whether CGM is practical to use, whether women are satisfied with it, and whether it may help improve blood sugar control and pregnancy outcomes. A total of 100 pregnant women with gestational diabetes will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups: One group will use a continuous glucose monitoring device. The other group will continue with standard finger-prick blood glucose monitoring. Both groups will receive the same medical care, including dietary advice, physical activity recommendations, and insulin treatment if needed. Participants will attend regular pregnancy visits every 2 to 3 weeks until delivery, as part of usual care. No extra hospital visits are required because of the study. Women using CGM will receive training on how to use the device. The researchers will compare blood sugar control, the need for insulin, pregnancy complications, and newborn outcomes such as birth weight and episodes of low blood sugar after birth. The study will also assess how satisfied women are with their glucose monitoring method and how it affects their quality of life. This is a pilot study, which means its main goal is to determine whether a larger study should be carried out in the future. The results will help researchers understand whether continuous glucose monitoring could improve the care of women with gestational diabetes and their babies.

Effect of an Early and Intensified Nutritional Intervention on the Risk of Developing Gestational Diabetes Mellitus

The goal of this clinical trial is to learn if a nutritional intervention based on a Mediterranean diet (MedDiet), initiated early in pregnancy, reduces the incidence of gestational diabetes mellitus (GDM) and other adverse maternal, fetal and obstetric events in pregnant women considered high-risk. It will also learn about the stratification of GDM risk based on clinical, anthropometric, analytical and genetic characteristics. The main questions it aims to answer are: * Does the nutritional intervention based on MedDiet reduce the incidence of GDM in women with high risk? * How can we stratify the risk of GDM? Researchers will compare an advanced nutritional intervention based on a Mediterranean diet to standard care (general recommendations given at the beginning of pregnancy). Participants will: * Receive intensive nutritional counselling or standard regular recommendations during the first trimester of pregnancy. * Visit the clinic at the time of the first ultrasound (gestational week 8-11) and at the time of screening for GDM (gestational week 24-26). * Undergo a genetic test performed with a buccal swab.

Pregnancy and Postpartum Breastfeeding Support for Patients With Gestational Diabetes

The investigators will use implementation methods to develop better breastfeeding support for patients with gestational diabetes as a way to prevent type 2 diabetes.

ULTRASOUND ASSESSMENT OF GASTRİC VOLUME IN PREGNANT WOMEN UNDERGOİNG ELECTİVE CESAREAN SECTİON, WITH AND WITHOUT GESTATİONAL DIABETES MELLITUS

THE PRIMARY OBJECTIVE OF THIS STUDY IS TO COMPARE GASTRIC VOLUME PRIOR TO ELECTIVE CESAREAN SECTION BETWEEN PREGNANT WOMEN DIAGNOSED WITH GESTATIONAL DIABETES MELLITUS (GDM) AND THOSE WITHOUT GDM. THE SECONDARY OBJECTIVES ARE TO EVALUATE THE EFFECT OF GDM ON PREOPERATIVE RESIDUAL GASTRIC VOLUME AND TO OBTAIN DATA THAT COULD CONTRIBUTE TO CLINICAL ANESTHESIA PRACTICES REGARDING THE RISK OF ASPIRATION. THIS STUDY AIMS TO OBTAIN OBJECTIVE ULTRASONOGRAPHIC DATA REGARDING THE ADEQUACY OF STANDARD FASTING PERIODS IN PREGNANT WOMEN, PARTICULARLY IN THE PRESENCE OF GDM.

Maternal Obesity, Breast Milk Composition, and Infant Growth

Today the majority of pregnant women in the United States are either overweight or obese at conception with their offspring having greater adiposity at birth, a 2-fold greater risk of later obesity, and neonatal insulin resistance. It was long thought that breast milk composition was fairly uniform among women, having been optimized through evolutionary time to provide adequate sole nutrition for the growing infant regardless of the environmental circumstances. However, recent evidence shows that breast milk is a highly complex fluid with significant inter-individual variation in hormonal and cytokine concentrations, human milk oligosaccharides (HMOs) and other features. Pervasive maternal obesity and gestational diabetes are evolutionarily novel conditions for the human species but little effort has yet been made to systematically examine how they are associated with breast milk adipose-tissue derived hormone and cytokine (adipocytokine) variation, HMOs, or other features, or whether that variation relates to infant metabolic status. The objective of this study is to comprehensively assess the "lactational programming" hypothesis, that is, whether or not recently documented variation in breast-milk composition is related to both maternal and infant metabolic status. The central hypothesis is that a graded, dose-response relationship between maternal adiposity and GDM exists with adipocytokine concentrations, HMOs, and other features in breast milk and that the milk concentrations of these features are associated with altered body composition in their exclusively breast-fed offspring. The results of the study will be used to design interventions to reduce maternal weight during pregnancy and lactation and to augment lactation education materials to focus on the needs of breastfeeding women with obesity and GDM.

Comparison of Metformin Versus Glyburide for Blood Sugar Control in Women With Gestational Diabetes

The goal of this randomized clinical trial is to compare metformin and glyburide for controlling blood sugar in pregnant women with gestational diabetes mellitus (GDM) who require treatment with oral medication. The main question the study aims to answer is: Q: Is treatment failure less common with metformin or glyburide in pregnant women with GDM? The study will include 92 pregnant women aged 18-45 years with a singleton pregnancy, diagnosed with GDM between 13 and 33 weeks of pregnancy and requiring medication to control blood sugar. Participants will be randomly assigned to one of two treatment groups. Participants in the metformin group will receive metformin, starting at 850 mg once daily and increased to a maximum of 2,550 mg per day according to their blood sugar levels. Participants in the glyburide group will receive glyburide, starting at 2.5 mg twice daily and increased according to their blood sugar levels, up to a maximum of 20 mg per day. Blood glucose levels will be monitored regularly using a glucometer. Treatment will be considered successful when at least 80% of the recorded blood glucose measurements are within the target range. Treatment failure will be defined as fewer than 80% of blood glucose measurements being within the target range after up to 4 weeks of treatment. Participants who have treatment failure or cannot continue the assigned medication because of adverse effects will be switched to insulin therapy. Participants will be followed during pregnancy until delivery. The study will record treatment failure as the primary outcome and will also assess maternal outcomes, including preeclampsia, polyhydramnios, and preterm delivery, as well as newborn outcomes including macrosomia and the need for admission to a neonatal intensive care unit (NICU). The study will determine whether metformin or glyburide provides better blood sugar control and reduces the need to switch to insulin in pregnant women with gestational diabetes.

Validating CGM for GDM

This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM). Pregnant individuals between the ages of 18-50 years old receiving prenatal care at Mount Sinai Hospital (e..g, E-Level clinic and Faculty Practice Associates) will be enrolled. Potential participants will be approached during their prenatal care appointments. Participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.

Determining the Effect of Food Ordering on Blood Glucose In Gestational Diabetes Mellitus (DEFI-GDM)

The goal of this clinical trial is to determine whether the sequence of macronutrient consumption affects post-prandial glycaemia in women with gestational diabetes mellitus. The main questions it aims to answer are: * The difference in the magnitude of postprandial rise in blood glucose between the two test meals as measured by Flash Glucose Monitoring (FGM) sensor, alongside blood/serum glucose from collected intravenous blood samples and finger prick results. * The difference in the magnitude of postprandial change in serum levels of gut hormones between the two test meals. * The difference in mean change in pre-post ingestion satiety scores between the two test meals. * The difference in 24 hour energy and macronutrient intake following the two test meals. Participants will attend two study visits at the Centre for Public Health, with an interval of at least two days between the visits and complete the following, anthropometric measurements, demographic and appetite questionnaires, glucose measurements, two food diaries and fasting blood samples and the consumption of the study breakfast. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Researchers will compare the results from participants between the two test meals to see if the order of macronutrient consumption has any effect on post-prandial glycaemia, gut hormones, satiety scores and energy and macronutrient intake.

Placental Biology in Health and Disease

Pre-eclampsia (PET) is a condition characterised by high blood pressure and damage to other organs, and is a leading cause of maternal and fetal complications such as fetal growth restriction (FGR). Gestational diabetes mellitus (GDM) involves abnormal blood sugar levels during pregnancy and can have both short and long-term impacts on the health of the mother and child. Both conditions are linked to placental dysfunction but the precise mechanisms behind these links remain unclear. A major focus of this study is on extracellular vesicles (EVs) which are tiny, bubble-like particles released by the placenta into the mother's and baby's bloodstreams. These EVs act as messengers, carrying proteins, lipids and genetic material that can influence how cells function, even in parts of the body far from the placenta. Notably, the number and content of these EVs change in conditions like PET and GDM, suggesting they may play a role in the development of these complications. This single-site, observational, laboratory study aims to investigate how these EVs contribute to maternal health and disease. To enable analysis across different physiological and pathological conditions pregnant participants with healthy pregnancies, pregnancies predisposed to PET and pregnancies complicated by GDM, FGR and PET will be recruited alongside healthy non-pregnant controls. Recruitment will be from the Oxford University Hospitals NHS Foundation Trust and the Nuffield Department of Women's and Reproductive Health, University of Oxford (who fund the research). Demographic and clinical data will be collected as well as blood, urine, breath, voice, placenta, umbilical cord, umbilical cord blood, amniotic fluid and/or uterine vein blood samples. Through examining EV content and function, it is hoped a better understanding of their role in pregnancy complications will be gained, including their potential as non-invasive biomarkers for early detection and targeted treatments, improving outcomes for mothers and babies worldwide.

Poi for Mama: a Pilot to Improve Maternal Microbiome and Gestational Diabetes Risk

This investigator-initiated, non-randomized pilot study evaluates the effect of daily consumption of fermented poi on the maternal microbiome and gestational diabetes risk during pregnancy. Fifty pregnant participants between approximately 12 and 24 weeks of gestation will receive one pound of poi daily for four weeks, accompanied by culturally tailored nutrition education delivered via secure text messaging. Changes in vaginal, oral, and rectal microbiome composition, diet quality, gestational diabetes diagnosis, and pregnancy-related outcomes will be assessed and compared with matched controls derived from an existing cohort. This study aims to inform the feasibility and design of a larger culturally grounded dietary intervention for gestational diabetes prevention.

Effects of Leg Ergometer Versus Arm Ergometer on Blood Glucose, Exercise Tolerance, Weight, and Psychological Stress Among Gestational Diabetic Patients

The current study is a single-blind, parallel-group randomized controlled trial involving 108 participants with diabetes during pregnancy. The trial will compare leg ergometer with arm ergometer. Interventions will be delivered three times per week for eight weeks. The primary outcomes are glucose, exercise tolerance, weight, and psychological stress. Assessments will be conducted at baseline and after eight weeks. The trial will be carried out at Jinnah hospital, Services hospital, Sir Ganga Ram Hospital, Lahore. The hypothesis is that the leg ergometer including aerobic exercise will result in greater reduction in glucose and exercise tolerance, weight and stress management than arm ergometer.

Feasibility Testing of the "MyGlucoCare" Smartphone App for Women With Gestational Diabetes

The goal of this pilot study is to test the feasibility and preliminary impact of "MyGlucoCare," a smartphone-based program designed to support women with gestational diabetes (GDM). The main questions it aims to answer are: Is the "MyGlucoCare" program practical and acceptable for participants? Does it show preliminary signs of improving self-management, blood sugar control, and well-being in women with gestational diabetes (GDM)? Researchers will conduct a single-arm study to gather initial data on the program's use and effects, which will be used to plan a larger future clinical trial. Participants will: Use the "MyGlucoCare" app for 8-12 weeks during their pregnancy. Receive personalized education, support from a clinician, and access to a moderated peer group through the app. Complete questionnaires and log health data via the app at the start, near the end of pregnancy, and after giving birth. Some participants will also take part in an interview to share their feedback on the program.

Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus

In order to ascertain the relative safety and effectiveness of insulin and OHAs in the treatment of GDM, well-designed, prospective clinical trials are required. GDM is growing more common, and proper care is crucial to preventing complications. Although the evidence is conflicting, both therapy approaches might be beneficial. To maximize outcomes for both mother and child, evidence-based recommendations for pregnant women with GDM must close this knowledge gap. Comparing the effects of insulin and metformin in gestational diabetes mellitus is the rationale for this study. We can thus give our people a medication with less fetal adverse effects based on these findings. Based on this empirical data, we can then incorporate some useful suggestions into our standard practice guidelines for the use of the more effective medication of the two for gestational diabetes mellitus in order to lower perinatal mortality and fetal morbidity.

mHealth Integrated Model of Hypertension, Diabetes and Antenatal Care in India and Nepal

Our research aims to address a critical gap in the provision of quality antenatal care (ANC) in India and Nepal, by developing and evaluating an intervention comprising of a tablet-based electronic decision support system (EDSS). This intervention -"mIRA" - is an mHealth integrated model of hypertension, diabetes, and antenatal care in primary care settings. mIRA aims to (a) prompt frontline health workers (FHWs) to provide evidence-based routine ANC, and also enhance the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia, whilst improving adherence to National ANC guidelines; (b) facilitate record-keeping and reporting and; (c) link providers across various levels of care to improve continuity of care. A cluster randomized controlled (cRCT) to assess the effectiveness of the mIRA EDSS in improving ANC and enhancing the detection and management of Pregnancy Induced Hypertension (PIH), Gestational Diabetes Mellitus (GDM), and anemia will be conducted in Telangana, India. A mixed-methods process evaluation will be conducted in both India and Nepal. The process evaluation will contribute to our understanding of the mechanisms contributing to changes (improvement) in the quality of ANC by using the EDSS intervention.

Natural Cervical Ripening to Prevent Pharmacological Induction of Labor - a Pilot Study.

As of today, around 25% of all vaginal births happen after induction of labor (IOL). The internal guidelines of the University Hospital Zurich currently recommend pregnant women with a non-insulin dependent gestational diabetes an IOL around term. One possibility to prevent an IOL and increase the chance for a spontaneous onset of birth is a ripening of the cervix by alternative methods in an outpatient setting. The primary objective of this study is to evaluate the effect of natural cervical ripening methods on the time interval between 37 weeks (beginning of the intervention) and the onset of spontaneous labor.

Screening for Dysglycemia During Postpartum Period in Women With GDM

Gestational diabetes mellitus (GDM) is one of the most common clinical conditions in pregnancy, with an increasing incidence due to the rise in overweight women and the postponement of motherhood. It is associated with perinatal complications and an increased risk of developing prediabetes and type 2 diabetes after delivery. Therefore, it is recommended that a 75g oral glucose tolerance test (OGTT-75g) be performed between 6 and 12 weeks postpartum. Despite its relevance, the rate of adherence to the test is low. Recent studies also indicate that measuring blood glucose one hour after the overload may be more sensitive than the traditional two-hour measurement in the early detection of dysglycemia. This study aims to evaluate strategies for qualifying the screening of metabolic changes in the postpartum period among women with GDM. The objectives are: (1) to analyze the impact of sending reminders via WhatsApp on the attendance rate for the 75g OGTT; and (2) to compare the frequency of prediabetes and diabetes diagnoses using two different diagnostic strategies applied to the same test-the traditional (fasting and 2-hour blood glucose) and the alternative (fasting and 1-hour blood glucose).

Gestational Diabetes and Health Outcomes in Mothers and Babies

Gestational diabetes mellitus (GDM) is a common pregnancy complication characterized by impaired glucose metabolism and increased insulin resistance. GDM is associated with adverse pregnancy outcomes and an increased long-term risk of metabolic and cardiovascular disease for both mother and offspring. This prospective observational cohort study aims to establish a longitudinal pregnancy and birth cohort of women diagnosed with GDM. Pregnant women with a positive 75 g oral glucose tolerance test (OGTT) between gestational weeks 24 and 28 will be recruited after diagnosis and followed through late pregnancy, delivery, and early postpartum. Participants will undergo two study visits during pregnancy, sample collection at delivery, and one postpartum visit 8-12 weeks after birth. Clinical data, physical measurements, questionnaire-based information, and biological samples will be collected from mothers and infants to enable comprehensive phenotyping of GDM pregnancies. Data and biosamples from this cohort will be used for descriptive and hypothesis-driven analyses and may be compared with data from an existing longitudinal cohort of healthy pregnancies to support interpretation of GDM-related changes.

Glycemic Markers for Predicting Gestational Diabetes in Pregnant Women With Previous Bariatric Surgery

Gestational diabetes mellitus (GDM) is associated with significant maternal and fetal complications. The standard diagnostic test for GDM is the 75-gram oral glucose tolerance test (OGTT). However, pregnant women who have undergone bariatric surgery may not tolerate OGTT due to dumping syndrome and gastrointestinal side effects. This creates diagnostic challenges in this specific population. The aim of this prospective observational study is to evaluate whether routinely measured glycemic markers, including fasting blood glucose, postprandial blood glucose, HbA1c, and urinary glucose levels, can predict the development of gestational diabetes mellitus and related pregnancy complications in women with prior bariatric surgery. Pregnant women aged 18-50 years with a history of bariatric surgery will be enrolled and followed throughout pregnancy. The predictive value of glycemic markers for GDM, macrosomia, and polyhydramnios will be analyzed using multivariable logistic regression models. This study aims to provide alternative diagnostic approaches for GDM screening in pregnant women who are unable to tolerate OGTT and to contribute to improving maternal and perinatal outcomes in this growing patient population.

Imprinting in Metabolic Diseases - Identifying Epigenetic Mechanisms in Human Gestational Diabetes Through Cell-free DNA

This clinical trials aims to investigate the impact of parental metabolism during pregnancy on fetal epigenetic signatures. The metabolic profiles of both parents will be evaluated through a blood sample collected from the father and an oral glucose tolerance test administered to the pregnant mother. Additionally, epigenetic signatures will be assessed using parental blood samples. Fetal epigenetic signatures can be identified by analyzing fetal cell-free DNA that circulates in the mother's bloodstream.