Research on the Preventive Effect of Family-centered Early Nursing Intervention on High-risk Population of Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The incidence of gestational diabetes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Systemic corticosteroids (e.g., cortisone, prednisone)
- •Activity-limiting comorbidities:
- •a) Severe medical complications contraindicating physical activity (e.g., unstable angina, advanced respiratory failure)
研究组 & 干预措施
Control group
干预措施: Control group：The interactive management nursing model on the wechat platform (Behavioral)
Intervention group
干预措施: Intervention group：Family-centered early care intervention (Behavioral)
结局指标
主要结局
The incidence of gestational diabetes
时间窗: 24 weeks of gestation
The number of cases of GDM/the total number of observed cases
次要结局
- Premature birth(From enrollment to delivery)
- Stillbirth(From enrollment to delivery)
- Fetal distress(Records during childbirth)
- Blood sugar status of pregnant women(24 weeks of gestation)
- The weight gain of pregnant women during pregnancy(From randomization to pregnancy termination (maximum assessment time: 42 weeks of gestation))
- Gestational weeks at delivery(From pregnancy confirmation to delivery (range: ≥20 weeks to ≤42 weeks))
- Complications during pregnancy(From enrollment to delivery)
- Polyhydramnios(Middle and late stages of pregnancy (such as being evaluated every 4 weeks after 20 weeks of pregnancy until delivery))
- Postpartum complications(From delivery to discharge (or within 42 days after delivery))
- Mode of delivery(Records during childbirth)
- Premature rupture of membranes(Pregnancy ≥37 weeks until before delivery)
- The length and cost of hospital stay after delivery(From delivery to discharge)
- Fetal growth restriction(The assessment should be conducted every 4 weeks after 20 weeks of pregnancy until delivery)
- Macrosomia(Records during childbirth)
- Fetal malformation(During the second trimester of pregnancy (18-24 weeks) and within 24 hours after birth)
- Neonatal respiratory distress syndrome(Within 7 days after birth)
- Neonatal hypoglycemia(Within 24 hours after birth)
- The rate of newborns admitted to the NICU(From birth to discharge (or within 28 days after birth))
研究者
Yan Lu
Clinical Professor
Nantong First People's Hospital