Status:
ACTIVE_NOT_RECRUITING
The Role of Early Nursing Intervention in the High-risk Population of Gestational Diabetes
Lead Sponsor:
Yan Lu
Conditions:
Early Nursing Intervention
Gestational Diabetes Mellitus
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Pregnant women who established prenatal examination cards in the prenatal outpatient department of our hospital from January 2025 to September 2025 were selected. According to the inclusion criteria, ...
Eligibility Criteria
Inclusion
- Gestational age \<10 weeks Singleton pregnancy confirmed by first-trimester ultrasound
- Primary caregiver availability: At least one primary caregiver (spouse or parent) who:
- Demonstrates adequate verbal communication and literacy skills (assessed by standardized evaluation)
- Voluntarily participates in the study with signed informed consent
- Metabolic risk factors meeting ≥1 criterion:
- Pre-pregnancy BMI \>24 kg/m²
- Maternal age ≥35 years at conception
- Documented history of polycystic ovary syndrome (PCOS)
- Fasting blood glucose (FBG) ≥5.1 mmol/L in early pregnancy
- Parental history of diabetes mellitus (either parent)
- Previous gestational diabetes mellitus (GDM)
- History of macrosomia (birth weight ≥4000g)
- Adverse obstetric history including:
- Preterm delivery (\<37 weeks) Stillbirth or fetal demise Congenital malformations Neonatal death or unexplained neonatal death
Exclusion
- Pre-existing medical conditions:
- Chronic hypertension (diagnosed pre-pregnancy)
- Renal disorders (e.g., chronic kidney disease stage ≥3)
- Cardiovascular diseases (e.g., coronary artery disease, heart failure)
- Prohibited medication use during pregnancy including:
- Indomethacin
- Phentolamine
- Diuretics (e.g., furosemide, hydrochlorothiazide)
- Phenytoin
- Systemic corticosteroids (e.g., cortisone, prednisone)
- Activity-limiting comorbidities:
- a) Severe medical complications contraindicating physical activity (e.g., unstable angina, advanced respiratory failure)
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06997835
Start Date
January 1 2025
End Date
September 30 2025
Last Update
May 30 2025
Active Locations (1)
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1
Nantong First People's Hospital
Nantong, Jiangsu, China, 226001