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

Yan Lu

Status: Active, not recruiting

Conditions: Gestational Diabetes Mellitus; Early Nursing Intervention

Treatments: Behavioral: Intervention group：Family-centered early care intervention; Behavioral: Control group：The interactive management nursing model on the wechat platform

Study type: Interventional

Funder types: Other

Identifiers

NCT06997835

2025XM105

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

Control group

Experimental group

Treatment:

Behavioral: Control group：The interactive management nursing model on the wechat platform

Intervention group

Experimental group

Treatment:

Behavioral: Intervention group：Family-centered early care intervention