Gestational Diabetes Mellitus (GDM)

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Review clinical trials related to Gestational Diabetes Mellitus (GDM). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 226
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of Massachusetts, WorcesterUpdated: Sep 28, 2026Locations: 1
Eligibility criteria

Age greater than or equal to 18 [+2]

a history of acute or chronic pancreatitis [+9]

Status: Recruiting

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.

Participants needed: 60
Trial details
Age: 19+Biological sex: FemaleType: InterventionalSponsor: University of New BrunswickUpdated: Sep 28, 2026Locations: 1
Eligibility criteria

Pregnant individual with a singleton pregnancy [+14]

Pre-existing metabolic disease affecting glucose regulation, including type 1 di... [+3]

Status: Not yet recruiting

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.

Participants needed: 1,500
Trial details
Age: 18-40Biological sex: FemaleType: InterventionalSponsor: Peking University Third HospitalUpdated: Sep 22, 2026Locations: 1
Eligibility criteria

Aged 18-40 years; [+5]

Maternal factors: signs of labor; prelabor rupture of membranes; history of cesa... [+4]

Status: Not yet recruiting

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.

Participants needed: 100
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Hospital Clinic of BarcelonaUpdated: Sep 18, 2026Locations: 1
Eligibility criteria

Pregnant women aged ≥18 years [+5]

Preexisting type 1 or type 2 diabetes mellitus [+5]

Status: Not yet recruiting

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.

Participants needed: 1,200
Trial details
Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Hospital San Carlos, MadridUpdated: Sep 16, 2026Locations: 1
Eligibility criteria

Unassisted single pregnancy; [+3]

Multiple or assisted pregnancies; [+2]

Status: Recruiting

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.

Participants needed: 10
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of California, DavisUpdated: Sep 14, 2026Locations: 1
Eligibility criteria

≥18 years old and able to communicate in English [+3]

Subjects not meeting the inclusion criteria will be considered ineligible for pa...

Status: Not yet recruiting

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.

Participants needed: 54
Trial details
Age: 18-65Biological sex: FemaleType: ObservationalSponsor: Gaziantep City HospitalUpdated: Sep 14, 2026Duration: 1 Day
Eligibility criteria

PREGNANT WOMEN AGED 18-65 YEARS WITH A SINGLETON PREGNANCY, [+3]

EMERGENCY CESAREAN SECTION CASES. [+6]

Status: Recruiting

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.

Participants needed: 92
Trial details
Phase: Phase 4Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Nishtar Medical UniversityUpdated: Sep 3, 2026Locations: 1
Eligibility criteria

Gestational diabetes requiring drug treatment [+1]

Known cases of diabetes mellitus [+3]

Status: Recruiting

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.

Participants needed: 150
Trial details
Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Icahn School of Medicine at Mount SinaiUpdated: Aug 13, 2026Locations: 3
Eligibility criteria

Ages 18-50 [+2]

Multiple fetal gestation [+5]

Status: Recruiting

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.

Participants needed: 35
Trial details
Age: 18-50Biological sex: FemaleType: InterventionalSponsor: Queen's University, BelfastUpdated: Aug 12, 2026Locations: 1
Eligibility criteria

Pregnant women with gestational diabetes mellitus [+2]

History of type 1 or type 2 diabetes mellitus [+5]

Status: Not yet recruiting

Co-designing Enhanced Models of Care for First Nations Children at Risk for Childhood-onset Type 2 Diabetes

The overall objective: to co-design and implement targeted and timely community led strategies to improve the health of the Next Generation and end the intergenerational impact of T2D in this population.

Participants needed: 600
Trial details
Age: Up to 18Biological sex: AllType: ObservationalSponsor: University of ManitobaUpdated: Aug 3, 2026Locations: 1Duration: 4 Years
Eligibility criteria

Pregnant women with type 2 diabetes or no diabetes. [+3]

Parents or children with type 1 diabetes. [+1]

Status: Recruiting

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.

Participants needed: 360
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: University of OxfordUpdated: Jul 23, 2026Locations: 1
Eligibility criteria

Female, aged 18 years or above [+7]

Non-pregnant participants with active health conditions that could confound stud... [+1]

Status: Recruiting

Assessment of Quality of Life and Psychological Factors Among Women Diagnosed With Gestational Diabetes Mellitus

Summary of Research Protocol Title: Quality of Life and Associated Psychological Factors in Women with Gestational Diabetes Mellitus Background: Gestational Diabetes Mellitus (GDM) is a common metabolic disorder of pregnancy characterized by glucose intolerance first recognized during pregnancy. The prevalence of GDM is increasing globally and in India due to the rising burden of obesity and diabetes. While much research has focused on the physiological and obstetric consequences of GDM, its impact on quality of life (QoL) and psychological well-being remains less explored. Women diagnosed with GDM often experience anxiety, stress, fear regarding pregnancy outcomes, and concerns about their own and their baby's health, which may negatively affect their quality of life and adherence to treatment. Research Gap: Existing studies have primarily concentrated on glycemic control and pregnancy outcomes, with limited attention to the psychosocial dimensions of GDM. The relationship between quality of life and psychological factors such as anxiety, depression, stress, and social support among women with GDM has not been adequately studied, particularly in the Indian population. Aim: To assess the quality of life among women with Gestational Diabetes Mellitus and examine its association with psychological factors. Objectives: To study the quality of life in women with GDM. To compare the quality of life between pregnant women with GDM and those without GDM. To assess associated psychological factors, including anxiety, depression, stress, and perceived social support, among women with GDM. Methodology: A comparative cross-sectional study will be conducted among pregnant women aged 20-40 years attending the OPD and IPD services of Christian Medical College \& Hospital, Ludhiana. Women diagnosed with GDM according to DIPSI criteria (2-hour post 75 g oral glucose load blood sugar ≥140 mg/dL) will constitute the study group, while pregnant women without GDM will serve as controls. Data regarding demographic characteristics, obstetric history, medical history, family history of diabetes, and socioeconomic status will be collected using a structured case record form. Socioeconomic status will be assessed using the Modified Kuppuswamy Scale. Psychological assessment will include: GAD-7 for anxiety symptoms. PHQ-9 for depressive symptoms. MSPSS for perceived social support. Quality of life will be assessed using a validated QoL questionnaire appropriate for women with GDM. Sample Size: Based on previous literature, a minimum sample size of 103 participants in each group (GDM and non-GDM) has been calculated, resulting in a total sample size of 206 participants. Statistical Analysis: Data will be analyzed using SPSS version 26.0. Quantitative variables will be compared using Student's t-test or Mann-Whitney U test, while categorical variables will be analyzed using Chi-square or Fisher's exact test. A p-value \<0.05 will be considered statistically significant. Expected Outcome: The study is expected to provide insights into the quality of life of women with GDM and identify psychological and social factors associated with poorer QoL. The findings may help healthcare providers develop holistic and patient-centered management strategies that address not only glycemic control but also the psychosocial needs of pregnant women with GDM.

Participants needed: 206
Trial details
Age: 20-40Biological sex: FemaleType: ObservationalSponsor: Lovely Professional UniversityUpdated: Jul 21, 2026Locations: 1Duration: 15 Days
Eligibility criteria

1) All Pregnant females admitted to Christian Medical College & Hospital, Ludhia...

1) Subjects not willing to participate.

Status: Recruiting

The Impact of Myo-Inositol on Glycemic Control and Oxidative Stress in Gestational Diabetes Mellitus

The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM). The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group assignment. They will be allocated either to an intervention group (myo-inositol + folic acid) or a control group (folic acid). Both supplements will be taken until delivery. The intervention group supplement contains 4 g myo-inositol and 400 μg folic acid (BIOGENA GmbH, Salzburg) and is to be taken twice daily with water - three capsules per meal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH, Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study, both participants and study personnel will be aware of group assignments. Blood glucose measurements will be repeated mid-study (around the 33rd week of pregnancy) and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluation of glucose measurements, participants will keep dietary logs during these periods. Three study visits are planned, during which the following assessments will be conducted. To determine the primary outcome, "time in range (TIR)" (time spent within the target glucose range), three glucose sensor measurements will be performed. At each visit, blood samples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA-IR), insulin dosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels), and inflammatory markers (interleukin-6 (IL-6), C-reactive protein (CRP)). Anthropometric measurements (weight gain, blood pressure, pulse) and body composition (Bioelectrical Impedance Analysis) will also be performed. Additionally, maternal and fetal birth outcomes will be recorded, including cesarean section rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemia occurrence. To assess participants' well-being and physical activity, questionnaires will be distributed at the beginning and end of the study.

Participants needed: 40
Trial details
Age: 18-45Biological sex: FemaleType: InterventionalSponsor: Medical University of ViennaUpdated: Jul 6, 2026Locations: 2
Eligibility criteria

GDM diagnosis [+3]

T2DM [+8]

Status: Recruiting

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.

Participants needed: 50
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of HawaiiUpdated: Jul 2, 2026Locations: 3
Eligibility criteria

Be at least 10 weeks into their pregnancy [+6]

Less than 10 weeks pregnant or already in third trimester [+6]

Status: Recruiting

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.

Participants needed: 108
Trial details
Age: 18-35Biological sex: FemaleType: InterventionalSponsor: Lahore University of Biological and Applied SciencesUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

Female participants aged 18-35 years. [+9]

Previous Cesarean section or medically indicated bed rest. [+8]

Status: Not yet recruiting

Polyphenol Intake, Mediterranean Diet Adherence, and Oxidative Stress in Pregnancy

This study is a randomized controlled clinical trial designed to evaluate the effect of a polyphenol-rich dietary intervention during pregnancy on endothelial function, oxidative stress biomarkers, and maternal and neonatal outcomes. Pregnancy is associated with metabolic and vascular adaptations, and complications such as gestational diabetes and hypertensive disorders are linked to endothelial dysfunction and increased oxidative stress. Dietary factors, particularly adherence to the Mediterranean diet and intake of polyphenol-rich foods, may play a protective role. Pregnant women will be randomly assigned to either an intervention group or a control group. The intervention consists of daily consumption of 10 g of natural non-alkalized cocoa and structured dietary counseling aimed at achieving at least five daily servings of fruits and vegetables, alongside general Mediterranean diet recommendations. The intervention will last 12 weeks, from early to mid-pregnancy. Biomarkers of endothelial function and oxidative stress will be measured at different time points, along with clinical maternal outcomes (including gestational diabetes and hypertensive disorders) and neonatal outcomes. The aim is to determine whether this dietary intervention improves endothelial function, reduces oxidative stress, and contributes to better pregnancy outcomes.

Participants needed: 60
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of SalamancaUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

Pregnant women aged 18 years or older. [+5]

Medical or obstetric conditions that contraindicate dietary modifications. [+7]

Status: Recruiting

Protective Effect of Lactation Against Gestational Diabetes Mellitus in Subsequent Pregnancies: A Prospective Observational Cohort Study

Gestational diabetes mellitus (GDM) is a common metabolic disorder of pregnancy associated with increased maternal and fetal morbidity. Lactation has been suggested to improve maternal glucose metabolism, enhance insulin sensitivity, and reduce the risk of future glucose intolerance. However, evidence regarding the protective effect of lactation on the development of GDM in subsequent pregnancies remains limited. This prospective observational cohort study aims to evaluate the association between lactation and the risk of gestational diabetes mellitus and related pregnancy complications in women who conceive during the lactation period. Routine glycemic markers including fasting plasma glucose, HbA1c, glycosuria, and 75-g oral glucose tolerance test (OGTT) results will be recorded. Ultrasonographic findings including fetal abdominal circumference percentile, estimated fetal weight percentile, and amniotic fluid index will also be assessed. The study will investigate whether lactation is associated with a reduced risk of GDM, fetal macrosomia, and polyhydramnios in subsequent pregnancies.

Participants needed: 140
Trial details
Age: 18-50Biological sex: FemaleType: ObservationalSponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUpdated: Jun 3, 2026Locations: 2
Eligibility criteria

Pregnant individuals aged 18 to 50 years. [+5]

Age below 18 years. [+4]

Status: Recruiting

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.

Participants needed: 30
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Hong Kong Metropolitan UniversityUpdated: May 22, 2026Locations: 1
Eligibility criteria

Pregnant women diagnosed with Gestational Diabetes Mellitus (GDM) via a 75g Oral... [+3]

Pre-existing diagnosis of Type 1 or Type 2 diabetes mellitus. [+3]

Status: Recruiting

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.

Participants needed: 74
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: University of ZurichUpdated: May 14, 2026Locations: 1
Eligibility criteria

Singleton gestation [+5]

Pregnant women with multiple gestation [+8]

Status: Recruiting

Cardiometabolic Disease and Substrate Metabolism

This study's primary purpose is to determine the potential relationship between cardiometabolic disease, specifically insulin resistance (HOMA-IR), and maternal lipid oxidation.

Participants needed: 50
Trial details
Age: 18-45Biological sex: FemaleType: ObservationalSponsor: University of Tennessee Graduate School of MedicineUpdated: May 4, 2026Locations: 1Duration: 9 Months
Eligibility criteria

Age 18-45 [+6]

Type 2 Diabetes Mellitus [+13]

Status: Not yet recruiting

The ROOT Study: Scaling the 'Standard of Care Plus' Obstetric Nutrition Model to Optimize Maternal and Infant Health

The 'Standard of Care Plus' ('PLUS') model in the ROOT Study consists of analyzing select micronutrient and gene variants of pregnant females to construct trimester-specific and personalized nutrition and lifestyle recommendations in collaboration with in-person standard obstetric care (SOC). In 2014, the investigators demonstrated statistically significant reductions in adverse maternal and infant outcomes using the 'PLUS' model compared to SOC alone. Further study in a 50% Medicaid Oregon 'PLUS' cohort (N=387) demonstrated association with highly significant risk reductions in all primary outcomes (p-value \<0.001): preterm birth: relative risk (RR) = 0.238 (4.2x less likely), hypertensive disorders of pregnancy: RR = 0.229 (4.4x less likely), gestational diabetes: RR = 0.071 (14x less likely), small for gestational age: RR = 0.252 (4x less likely), and large for gestational age: RR = 0.357 (2.8x less likely). A 100% Medicaid and ethnically diverse Nevada 'PLUS' cohort showed similar trends in all outcomes that were not statistically significant because of small sample size. Structured as a prospective interventional study, the study evaluates whether the 'PLUS' model can achieve similar outcome improvements within the Novant Health (NH) system in North Carolina. The study will assess both clinical outcomes and digital nutrition platform performance within the existing healthcare infrastructure. The primary hypothesis of the ROOT study is that collaborative implementation of the 'PLUS' nutritional care model at NH Triad Obstetrics/Gynecology (OB/GYN) Clinic will be associated with reduced maternal and infant adverse outcome rates when compared to historical regional and NH system outcomes in those who received SOC alone. The secondary hypothesis of the ROOT Study is that the 'PLUS' model applied during pregnancy will be associated with reduced pediatric adverse outcomes. The 'PLUS' offspring that remain in the NH system will be observed longitudinally over 5 years with chart review at birth through 2 weeks of age, and at 1, 3, and 5 years of life. The outcomes assessed include neonatal intensive care unit (NICU) admission in the first two weeks of life, atopic dermatitis, eczema, asthma, allergies, otitis media, obesity, and autism. The 'PLUS' adverse outcome rates will be compared to adverse outcome rates in children born regionally and nationally under SOC alone. Participant compliance with the 'PLUS' model, and participant and nutritionist access to the digital health platform will be studied during each trimester of use, as well as in the postpartum time period. The exploratory hypothesis is that the digital platform will not affect access, compliance, and rates of maternal and neonatal adverse outcomes.

Participants needed: 500
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: GrowBaby Life ProjectUpdated: Apr 30, 2026
Eligibility criteria

Pregnant women receiving care at NH Triad OB/GYN [+4]

> 20 weeks gestational age [+3]

Status: Recruiting

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).

Participants needed: 182
Trial details
Biological sex: FemaleType: InterventionalSponsor: University of Sao Paulo General HospitalUpdated: May 4, 2026Locations: 1
Eligibility criteria

initial fasting blood glucose ≥ 92mg/dL OR [+1]

Status: Recruiting

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.

Participants needed: 400
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Medical University of GrazUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

ongoing pregnancy prior to the 32nd gestational week and a positive GDM screenin...

gestational age 32nd gestational week [+1]

Status: Recruiting

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.

Participants needed: 84
Trial details
Age: 18-50Biological sex: FemaleType: ObservationalSponsor: Burak Deniz AydoğduUpdated: Apr 8, 2026Locations: 1Duration: 9 Months
Eligibility criteria

Pregnant women aged 18-50 years [+5]

Age <18 years or >50 years [+3]