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Gestational Diabetes clinical trials

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NCT ID: NCT06327191 Not yet recruiting - Clinical trials for Gestational Diabetes

EMERGE Mothers and Kids

Start date: March 2024
Phase:
Study type: Observational

The EMERGE Mothers and Kids study is a follow-up to the EMERGE trial of women with GDM (N=535) that aimed to determine the effect of the addition of metformin compared to placebo on insulin initiation rates, maternal weight gain and perinatal morbidity and mortality. The primary objectives of the EMERGE Mothers and Kids follow up study are: 1. to determine whether treatment with metformin leads to a reduction in maternal disorders of glucose, metabolic syndrome, obesity, hypertension and lipids at up to 6 years post the index pregnancy; 2. to examine the impact of metformin on maternal anxiety, depression, quality of life and breast feeding duration; 3. to examine whether exposure to metformin leads to a reduction in obesity in the offspring at follow up; 4. to determine whether treatment with metformin during pregnancy, in women with GDM, leads to a reduction in adiposity in the offspring at follow up as measured by anthropometric measurements and sum of skinfolds.

NCT ID: NCT06320054 Not yet recruiting - Clinical trials for Gestational Diabetes

Preventing Obstetric Complications With Dietary Intervention

PLATE
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to learn whether access to healthy and fresh food, health coaching, and nutrition support intervention can reduce adverse birth outcomes in pregnant women. The main questions it aims to answer are: - Does access to healthy and fresh food, health coaching and nutrition support reduce the risk of gestational diabetes or preeclampsia and ultimately improve health outcomes for mothers and their newborns? - Are participants able to successfully utilize the health program? Are participants satisfied and self-equipped to apply the teachings of the program within their lives following their participation in the study? Participants will be randomly assigned to one of two groups. Participants in the standard of care will be asked to: - Complete surveys - Biometric screenings Participants in the intervention group will be asked to: - Complete surveys - Biometric screenings - Participate in weekly personal health coaching - Receive and consume provided weekly meals. Researchers will compare the standard of care to those who receive the intervention to see the impact of the intervention on clinical outcomes including: gestational weight gain, blood pressure, diagnosis of gestational diabetes, diagnosis of gestational hypertension or preeclampsia, and gestational age at birth.

NCT ID: NCT06310356 Not yet recruiting - Clinical trials for Gestational Diabetes

Continuous Glucose Monitoring for Women With Gestational Diabetes

CORDELIA
Start date: September 2024
Phase: N/A
Study type: Interventional

There are a few ongoing large randomized controlled trials (RCT's) on continuous glucose monitoring (CGM) in women with gestational diabetes (GDM) powered for pregnancy outcomes. However, none of these studies included women diagnosed with early GDM. The CORDELIA trial is a Belgian open-label multi-centric RCT with 17 centers in women with GDM (including both early and late GDM). Women will be randomized 1/1 to either treatment with CGM (intervention group, Freestyle Libre 3) or continue with self-monitoring of blood glucose (SMBG) with glucometer in line with normal routine (control arm). The study ends at the postpartum oral glucose tolerance test (OGTT 6-24 weeks postpartum) to screen for glucose intolerance.

NCT ID: NCT06292871 Not yet recruiting - Clinical trials for Gestational Diabetes

The Use of Social Media Platform to Continuously Support Pregnant Women With Gestational Diabetes Mellitus

Start date: March 2024
Phase: N/A
Study type: Interventional

To assess the efficacy of utilizing a social media platform for dietary and lifestyle management in improving acceptance and blood glucose control in patients with gestational diabetes mellitus (GDM), compared to the control group under usual care. Specifically, i. To measure the participants' acceptability and satisfaction levels of receiving intervention through the social media platform. ii. To measure the feasibility of using the social media platform to provide GDM support through participants' engagement levels and feedback questionnaire. iii. To measure the efficacy of using the social media platform to manage emotional responses in women with GDM. iv. To measure the efficacy of using the social media platform to optimize glycemic control in women with GDM.

NCT ID: NCT06234332 Not yet recruiting - Obesity Clinical Trials

Peking University Birth Cohort in Weifang (PKUBC-WF)

Start date: February 1, 2024
Phase:
Study type: Observational

The PKUBC-WF is a prospective cohort study carried out in Weifang city of Shandong, China. The primary aim of this study is to investigate the short-term and long-term effects of pre-pregnant and prenatal exposure on maternal and child health. Data are collected regarding environmental, nutritional and lifestyle exposures as well as short-term and long-term health outcomes of mothers and their children from birth to before 18 years old. Biological samples including peripheral blood, urine, placenta, umbilical cord, cord blood, and faeces are also collected.

NCT ID: NCT06209411 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Community Health Worker-Led Postpartum Diabetes Screening

Start date: March 5, 2024
Phase: N/A
Study type: Interventional

Women who experience gestational diabetes are at high risk of developing type 2 diabetes mellitus in the postpartum period-especially in low- and middle-income countries like India where the burden of diabetes is high and disproportionately affects women- but few receive the World Health Organization-recommended postpartum diabetes screening test. The investigators propose a cluster randomized clinical trial to determine whether community health worker-administered, home-based testing increases uptake of postpartum diabetes screening in the urban slums of Pune, India. The proposed study will provide an acceptable and scalable model that can be used to improve postpartum diabetes screening in other low-income settings, thereby improving early detection of diabetes in women and preventing morbidity and mortality in this high-risk population.

NCT ID: NCT06200519 Not yet recruiting - Clinical trials for Gestational Diabetes

Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography

DiFuSE
Start date: January 2024
Phase:
Study type: Observational

The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined antenatal, intrapartum, maternal, and neonatal factors on cardiac function. The main question it aims to answer are: - What are the normal reference ranges for parameters of diastolic cardiac function in neonates? - How are these influenced by maternal, intrapartum and neonatal factors? - Do the diastolic changes noted during the first two days of life persist into infancy? Participants will have four echocardiographic assessments in total: - Two during the first 48 hours of life (prior to discharge home) - Two during infancy (as an outpatient)

NCT ID: NCT06190405 Not yet recruiting - Clinical trials for Gestational Diabetes

Universal Hemoglobin A1c Versus Risk-based Screening for Early Gestational Diabetes Mellitus (EARLY GDM): A Randomized Controlled Trial

EARLYGDM
Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to compare the rate of large-for-gestational-age neonates between universal screening with glycated hemoglobin (A1C) and early risk-based screening with a glucose tolerance test (GTT) among pregnancies that present to prenatal care at <16 weeks 6 days.

NCT ID: NCT06184373 Not yet recruiting - Clinical trials for Gestational Diabetes

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

ENGAGED
Start date: June 1, 2024
Phase:
Study type: Observational

One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

NCT ID: NCT05981547 Not yet recruiting - Clinical trials for Gestational Diabetes

Patterns and Glycaemic Endpoints for Diagnosing Gestational Diabetes

PAGED-GDM
Start date: November 2023
Phase:
Study type: Observational

Gestational diabetes (GDM) develops during pregnancy and is becoming increasingly common. The condition is associated with adverse outcomes for mother and baby during both the pregnancy and delivery period. This study compares glucose variability (recorded by a continuous glucose monitoring (CGM) sensor) in pregnant women who have been diagnosed with GDM with pregnant woman who do not have the diagnosis but are at high risk. The sensors will be applied to 400 participants around the time of their standard test for GDM, with a randomly selected 60 of these patients forming a sub-group later in the study to assess for progression of high blood glucose. At present, a positive oral glucose tolerance test (OGTT) is used to confirm the diagnosis of GDM but the test can be unreliable leading to potential diagnostic error. CGM devices are used extensively in the management of Type 1 diabetes and GDM, and have also shown potential to be used in the diagnosis of Type 2 diabetes. If this study can demonstrate similar trends in glucose variability between OGTT positive patients and those who are OGTT negative but are at high risk for the condition, then further research into the utility of CGM as a diagnostic alternative or supplement to the OGTT would be indicated. The investigators will recruit 400 patients at high risk for GDM, give them a blinded CGM device, and compare the CGM glucose data with their OGTT result, their initial risk factors for GDM, their pregnancy outcome and their need for treatment. The investigators will use the data to test our hypothesis that a positive OGTT result does not predict hyperglycaemia in pregnancy.