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

NCT06997835 | Active Not Recruiting DMC

• 1 other identifier: 2025XM105
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Nursing Intervention; Gestational Diabetes Mellitus

Keywords

Gestational diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• The incidence of gestational diabetes

  The number of cases of GDM/the total number of observed cases

  24 weeks of gestation

Secondary Outcomes (18)

• 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)

Study Arms (2)

Control group

EXPERIMENTAL

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

Intervention group

EXPERIMENTAL

Behavioral: Intervention group：Family-centered early care intervention

Interventions

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

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.

Control group

Intervention group：Family-centered early care intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yan Lu: lead

Study Sites (1)

Nantong First People's Hospital

Nantong, Jiangsu, 226001, China

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)