Clinical trial NCT06997835: The Role of Early Nursing Intervention in the High-risk Population of Gestational Diabetes
Official title: Research on the Preventive Effect of Family-centered Early Nursing Intervention on High-risk Population of Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Early Nursing Intervention
Gestational Diabetes Mellitus
Keywords: Gestational diabetes mellitus
Lead sponsor: Nantong First People's Hospital
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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, 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 criteria: 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 outcomes:
measure: The incidence of gestational diabetes
timeFrame: 24 weeks of gestation
Secondary outcomes:
measure: Blood sugar status of pregnant women
timeFrame: 24 weeks of gestation
measure: The weight gain of pregnant women during pregnancy
timeFrame: From randomization to pregnancy termination (maximum assessment time: 42 weeks of gestation)
measure: Gestational weeks at delivery
timeFrame: From pregnancy confirmation to delivery (range: ≥20 weeks to ≤42 weeks)
measure: Complications during pregnancy
timeFrame: From enrollment to delivery
measure: Polyhydramnios
timeFrame: Middle and late stages of pregnancy (such as being evaluated every 4 weeks after 20 weeks of pregnancy until delivery)
measure: Postpartum complications
timeFrame: From delivery to discharge (or within 42 days after delivery)
measure: Mode of delivery
timeFrame: Records during childbirth
measure: Premature rupture of membranes
timeFrame: Pregnancy ≥37 weeks until before delivery
measure: The length and cost of hospital stay after delivery
timeFrame: From delivery to discharge
measure: Fetal growth restriction
timeFrame: The assessment should be conducted every 4 weeks after 20 weeks of pregnancy until delivery
measure: Macrosomia
timeFrame: Records during childbirth
measure: Premature birth
timeFrame: From enrollment to delivery
measure: Stillbirth
timeFrame: From enrollment to delivery
measure: Fetal malformation
timeFrame: During the second trimester of pregnancy (18-24 weeks) and within 24 hours after birth
measure: Fetal distress
timeFrame: Records during childbirth
measure: Neonatal respiratory distress syndrome
timeFrame: Within 7 days after birth
measure: Neonatal hypoglycemia
timeFrame: Within 24 hours after birth
measure: The rate of newborns admitted to the NICU
timeFrame: From birth to discharge (or within 28 days after birth)
Other outcomes:
Locations:
city: Nantong
country: China
facility: Nantong First People's Hospital
state: Jiangsu
Study officials:
References: