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

NCT ID: NCT06997835

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control group

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Intervention group

Group Type: EXPERIMENTAL

Intervention group：Family-centered early care intervention

Intervention Type: 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.

Interventions

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 Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yan Lu

OTHER

Sponsor Role: lead

Responsible Party

Yan Lu

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nantong First People's Hospital

Nantong, Jiangsu, China

Countries

China

Other Identifiers

2025XM105

Identifier Type: -

Identifier Source: org_study_id