Clinical Research Directory
Browse clinical research sites, groups, and studies.
Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal Outcomes in Gestational Diabetes
Sponsor: University of Split, School of Medicine
Summary
The goal of this observational study is to learn how sleep quality, mental health, lifestyle behaviors, and metabolic markers are related to glucose control and pregnancy outcomes in women with gestational diabetes mellitus (GDM). The main questions it aims to answer are: * Do differences in sleep quality, anxiety levels, and eating behaviors relate to differences in glycemic control in women with GDM? * Are maternal metabolic markers (such as glucose, liver enzymes, and lipid levels) associated with perinatal outcomes such as birth weight, cesarean delivery, and neonatal complications? * To compare women who undergo short inpatient glucose monitoring with women who undergo home-based digital glucose monitoring to see if the mode of monitoring is related to differences in sleep, mental health, metabolic profiles, or perinatal outcomes. Participants will: * Complete questionnaires on sleep, anxiety, lifestyle, and eating behaviors * Undergo routine laboratory testing, including metabolic and blood markers. * Have glucose monitored either during a short hospital stay or through home use of the FreeStyle Libre sensor. * Be followed from GDM diagnosis (24-34 weeks) until delivery to assess maternal and newborn outcomes
Official title: Integrated Assessment of Sleep, Mental Health, Lifestyle Behaviors, Metabolic Markers, and Perinatal Outcomes in Women With Gestational Diabetes Mellitus: A Prospective Cohort Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2025-11-01
Completion Date
2030-01-01
Last Updated
2026-01-02
Healthy Volunteers
No
Conditions
Interventions
Home-Based Glucose Monitoring
Intervention Description: Home-Based Glucose Monitoring Participants undergo short-term outpatient glucose monitoring as part of routine GDM care. They follow a written schedule for capillary glucose checks while continuing normal daily activities. Data are reviewed at the follow-up visit, where routine laboratory tests and a fetal ultrasound are also performed. This approach reflects standard outpatient management for women able to return for next-day review.
Inpatient Glucose Monitoring
Participants undergo a 24-hour hospital admission for scheduled capillary glucose measurements using standard hospital glucometers. During admission, participants follow the hospital's predetermined meal plan and receive continuous nursing oversight. A fetal ultrasound and routine laboratory testing are performed during the stay. This pathway follows usual clinical practice for women who require or are assigned inpatient monitoring based on logistical or clinical considerations.
Locations (1)
University hospital of Split
Split, Croatia