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Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal Outcomes in Gestational Diabetes 100 À domicile Observationnel Mode de vie

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07314944 est une étude observationnel pour Diabète gestationnel. Son statut actuel est : en recrutement. L'étude a débuté le 1 novembre 2025 et vise à recruter 100 participants. Dirigée par University of Split, School of Medicine, l'étude devrait être terminée d'ici le 1 janvier 2030. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 janvier 2026.
Résumé succinct

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 materna...
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Description détaillée
Gestational diabetes mellitus (GDM) is associated with disturbances in glucose regulation as well as a range of behavioral, psychological, and metabolic factors that may contribute to pregnancy outcomes. This prospective observational cohort study follows pregnant women with newly diagnosed GDM to evaluate how sleep quality, anxiety, eating behaviors, physical activity, and metabolic markers relate to glycemic contro...Afficher plus
Titre officiel

Integrated Assessment of Sleep, Mental Health, Lifestyle Behaviors, Metabolic Markers, and Perinatal Outcomes in Women With Gestational Diabetes Mellitus: A Prospective Cohort Study

Pathologies
Diabète gestationnel
Autres identifiants de l'étude
  • 520-03/25-01/206
Numéro NCT
NCT07314944
Date de début (réel)
2025-11-01
Dernière mise à jour publiée
2026-01-02
Date de fin (estimée)
2030-01-01
Inscription (estimée)
100
Type d'étude
Observationnel
Statut
En recrutement
Mots clés
Gestational Diabetes Mellitus
Sleep Quality
Anxiety
Mental Health
Eating Behavior
Lifestyle Factors
Physical Activity
Metabolic Markers
Glycemic Control
Perinatal Outcomes
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Group 1: Home-Based Digital Monitoring
Pregnant women with GDM who are managed as outpatients using a short (24-36 hour) period of home-based glucose monitoring with the FreeStyle Libre system. This pathway reflects routine clinical practice for women who can return for follow-up the next day and are able to use the digital device.
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 ...Afficher plus
Group 2: Hospital-Based Glucose Monitoring
Pregnant women with GDM who undergo short (24-hour) inpatient glucose monitoring according to standard hospital protocols. Allocation to this pathway follows clinical logistics (e.g., distance ≥80 km, island residence) and is not assigned by the research team.
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 inpat...Afficher plus
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Composite Adverse Perinatal Outcome
Proportion of participants experiencing any of the following outcomes in the newborn: macrosomia (birth weight ≥4000 g), neonatal hypoglycemia requiring intervention, admission to neonatal intensive care unit (NICU), 5-minute Apgar score \<7, or stillbirth.
At delivery/birth
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Sleep Quality (PSQI Score)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-administered questionnaire consisting of 19 items that generate a global score ranging from 0 to 21, as well as seven component (subscale) scores. The global PSQI score (range 0-21) and individual component scores will be analyzed as continuous variables. Higher PSQI scores indicate poorer sleep quality, while lower scores reflect better sleep quality.
At enrollment (24-34 weeks of gestation)
Anxiety Levels (STAI Score)
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI), a validated self-report instrument comprising two 20-item subscales: STAI-State (situational anxiety) and STAI-Trait (general anxiety proneness). Each subscale yields a score ranging from 20 to 80, analyzed as a continuous measure. Higher STAI scores indicate greater anxiety, whereas lower scores indicate lower anxiety levels.
At enrollment (24-34 weeks of gestation)
Eating Behaviors (TFEQ Subscales)
Eating behaviors will be assessed using the Three-Factor Eating Questionnaire (TFEQ), a validated self-report instrument that evaluates three domains of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating. Each TFEQ subscale is scored according to the instrument's standard scoring procedure and analyzed as a continuous measure. Higher scores on each subscale indicate a greater degree of the corresponding eating behavior (i.e., greater cognitive restraint, greater uncontrolled eating, or greater emotional eating), whereas lower scores indicate a lesser degree of that behavior.
At enrollment (24-34 weeks of gestation)
Mean Glucose Level
Average interstitial or capillary glucose level obtained from sensor downloads or hospital measurements.
During the 24-36 hour monitoring period (home or inpatient)
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Femme
  • Pregnant women aged 18 years or older
  • New diagnosis of gestational diabetes mellitus (GDM) according to IADPSG criteria
  • Gestational age 24-34 weeks at enrollment
  • Able to complete study questionnaires (sleep, anxiety, eating behavior, lifestyle)
  • Able to provide informed consent
  • For participants in the home-monitoring pathway: ability to use a smartphone and the FreeStyle Libre device

  • Pre-existing type 1 or type 2 diabetes mellitus
  • Current preeclampsia or major obstetric complications at enrollment
  • Major psychiatric disorders interfering with participation
  • Chronic use of sedatives or anxiolytic medications
  • Inability to complete questionnaires
  • Planned delivery outside the study's hospital network
  • Any condition judged by clinicians to interfere with participation or data reliability
University of Split, School of Medicine logoUniversity of Split, School of Medicine
University Hospital of Split logoUniversity Hospital of Split
Partie responsable de l'étude
Ivana Pavlinac Dodig, Investigateur principal, Assoc Prof, University of Split, School of Medicine
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
University hospital of Split, Split, 21000, Croatia
Blagoja Markoski, MD, Contact, +385 21 556 111, [email protected]
En recrutement