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The Role of Early Nursing Intervention in the High-risk Population of Gestational Diabetes

NCT06997835 · tracked via the Priya Life Science China tracker
Sponsor
Yan Lu
Phase
Not applicable
Started
2025-01-01
Last updated
2025-05-30

Condition(s) studied

Early Nursing InterventionGestational Diabetes Mellitus

Investigational drug(s) / intervention(s)

Control group:The interactive management nursing model on the wechat platformIntervention group:Family-centered early care intervention

Control group:The interactive management nursing model on the wechat platform: The intervention subjects of the control group: targeted at the pregnant and postpartum women themselves. Specifically, conduct routine outpatient prenatal examinations and health education for pregnant women. Regularly receive health education and pregnancy guidance intervention provided by the wechat platform. It includes: ① Setting specific wechat ringtones, 60-second voice messages and picture reminders every day; ② Basic knowledge education every Monday ③ Dietary guidance is provided every Tuesday. ④ Exercise guidance every Wednesday ⑤ Guidance on blood glucose monitoring every Thursday; Weight guidance is provided every Friday.

Intervention group:Family-centered early care intervention: The intervention subjects of the intervention group were parturients and their primary caregivers (spouses and parents). The specific measures are as follows: 1. Establish a family-centered healthcare team (FCC) It includes one chief physician, two attending physicians, one diabetes specialist nurse, two responsible nurses, one psychotherapist, and one nutritionist. The organization members will conduct FCC concept learning and knowledge training. 2. Interactive management nursing model on the wechat platform * Set specific wechat ringtones, 60-second voice messages and picture reminders every day; * Basic knowledge education every Monday; ③. Dietary guidance every Tuesday; ④. Exercise guidance every Wednesday; ⑤ Guidance on blood glucose monitoring every Thursday; ⑥. Weight guidance every Friday; ⑦. Strengthen home care guidance every Saturday and Sunday.

Study 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, 200 high-risk pregnant women with gestational diabetes mellitus (GDM) were selected. 100 people in the control group received conventional nursing intervention measures, and 100 people in the intervention group adopted the family-centered wechat platform interactive management nursing model. The observation period was from the start of prenatal examination to follow-up until delivery. The blood glucose conditions, glycated hemoglobin (HbA1c) levels, incidence of GDM, and weight gain during pregnancy of the two groups of pregnant women were observed. The pregnancy outcomes included: Gestational age at delivery, gestational complications (gestational hypertension, diabetic ketosis, preterm birth, post-term pregnancy, urogenital tract infection), polyhydramnios, mode of delivery (induced labor, shoulder dystocia, cesarean section), premature rupture of membranes, postpartum complications (postpartum hemorrhage, puerperal infection), etc. Perinatal outcomes: including fetal growth restriction, macrosomia, preterm birth, stillbirth, fetal malformations, fetal distress, neonatal respiratory distress syndrome, neonatal hypoglycemia, etc. We applied FCC to pregnant women at high risk of gestational diabetes mellitus (GDM) and advanced the intervention window to the beginning of prenatal examination (8-10 weeks of pregnancy). This may be able to improve weight gain and blood glucose levels during pregnancy in high-risk pregnant women, reduce the incidence of GDM, improve the final maternal and infant outcomes, and provide a certain theoretical basis for prenatal nursing intervention in pregnant women at high risk of GDM in the future.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: Gestational age \<10 weeks Singleton pregnancy confirmed by first-trimester ultrasound Primary caregiver availability: At least one primary caregiver (spouse or parent) who: 1. Demonstrates adequate verbal communication and literacy skills (assessed by standardized evaluation) 2. Voluntarily participates in the study with signed informed consent Metabolic risk factors meeting ≥1 criterion: 1. Pre-pregnancy BMI \>24 kg/m² 2. Maternal age ≥35 years at conception 3. Documented history of polycystic ovary syndrome (PCOS) 4. Fasting blood glucose (FBG) ≥5.1 mmol/L in early pregnancy 5. Parental history of diabetes mellitus (either parent) 6. Previous gestational diabetes mellitus (GDM) 7. History of macrosomia (birth weight ≥4000g) 8. Adverse obstetric history including: Preterm delivery (\<37 weeks) Stillbirth or fetal demise Congenital malformations Neonatal death or unexplained neonatal death Exclusion Criteria: Pre-existing medical conditions: 1. Chronic hypertension (diagnosed pre-pregnancy) 2. Renal disorders (e.g., chronic kidney disease stage ≥3) 3. Cardiovascular diseases (e.g., coronary artery disease, heart failure) Prohibited medication use during pregnancy including: 1. Indomethacin 2. Phentolamine 3. Diuretics (e.g., furosemide, hydrochlorothiazide) 4. Phenytoin 5. Systemic corticosteroids (e.g., cortisone, prednisone) Activity-limiting comorbidities: a) Severe medical complications contraindicating physical activity (e.g., unstable angina, advanced respiratory failure)

Primary outcome measure(s)

  • The incidence of gestational diabetes — 24 weeks of gestation
    The number of cases of GDM/the total number of observed cases

Trial sites (1)

FacilityCityRegionStatus
Nantong First People's Hospital Nantong Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06997835 on ClinicalTrials.gov ↗ ← All trials in China