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NCT Number: NCT06997835

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

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.

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Key information

Conditions

Early Nursing Intervention Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nantong First People's Hospital

Nantong, Jiangsu, 226001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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

Exclusion criteria

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)

Treatment and study plan

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.

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:

  • 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.
  • 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.

Primary outcomes

  1. The incidence of gestational diabetes

    Time frame: 24 weeks of gestation

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

Secondary outcomes

  1. Blood sugar status of pregnant women

    Time frame: 24 weeks of gestation

    The occurrence of abnormal OGTT (OGTT examination was performed at 24 weeks, and fasting, 1-hour, and 2-hour blood glucose were measured), and the level of glycated hemoglobin (HbA1c)

  2. The weight gain of pregnant women during pregnancy

    Time frame: From randomization to pregnancy termination (maximum assessment time: 42 weeks of gestation)

    The pre-pregnancy BMI was lower than the normal value, and the weight gain during pregnancy was 12.5-18.0kg. Those with a normal BMI before pregnancy gained 11.5 to 16.0kg during pregnancy. Those with an excessive BMI before pregnancy gained 7.0 to 11.5 kilograms during pregnancy. Obese people before pregnancy gain 5.0 to 9.0 kilograms during pregnancy. Weight gain during pregnancy is classified into three levels: insufficient weight gain, appropriate weight gain, and excessive weight gain. If the weight gain during pregnancy is less than the corresponding pre-pregnancy BMI weight gain range, it is considered insufficient weight gain; if it is greater than the corresponding weight gain range, it is considered excessive weight gain.

  3. Gestational weeks at delivery

    Time frame: From pregnancy confirmation to delivery (range: ≥20 weeks to ≤42 weeks)

    Gestational age at delivery (based on the gestational age confirmed by the last menstrual period or early ultrasound)

  4. Complications during pregnancy

    Time frame: From enrollment to delivery

    Clinical diagnosis of gestational hypertension, preeclampsia, diabetic ketoacidosis, preterm birth (<37 weeks), post-term pregnancy (≥42 weeks), and urogenital tract infections

  5. Polyhydramnios

    Time frame: Middle and late stages of pregnancy (such as being evaluated every 4 weeks after 20 weeks of pregnancy until delivery)

    Ultrasound diagnosis: Amniotic fluid index (AFI) >24 cm or maximum vertical amniotic fluid depth (MVP) >8 cm

  6. Postpartum complications

    Time frame: From delivery to discharge (or within 42 days after delivery)

    The incidence of postpartum hemorrhage (blood loss ≥500ml) and puerperal infection (body temperature ≥38℃+ laboratory confirmation)

  7. Mode of delivery

    Time frame: Records during childbirth

    The incidence rates of induced labor, shoulder dystocia and cesarean section

  8. Premature rupture of membranes

    Time frame: Pregnancy ≥37 weeks until before delivery

    Clinical diagnosis of natural rupture of membranes before labor

  9. The length and cost of hospital stay after delivery

    Time frame: From delivery to discharge

    Length of hospital stay (days) and total cost

  10. Fetal growth restriction

    Time frame: The assessment should be conducted every 4 weeks after 20 weeks of pregnancy until delivery

    Ultrasound assessment of fetal weight < the 10th percentile at the same gestational week

  11. Macrosomia

    Time frame: Records during childbirth

    Birth weight ≥4000g

  12. Premature birth

    Time frame: From enrollment to delivery

    The gestational age at delivery is less than 37 weeks

  13. Stillbirth

    Time frame: From enrollment to delivery

    Fetal death occurs after ≥20 weeks of pregnancy

  14. Fetal malformation

    Time frame: During the second trimester of pregnancy (18-24 weeks) and within 24 hours after birth

    Congenital malformations confirmed by ultrasound or clinically after birth

  15. Fetal distress

    Time frame: Records during childbirth

    Abnormal fetal heart rate monitoring (such as repeated late deceleration) or amniotic fluid fecal contamination

  16. Neonatal respiratory distress syndrome

    Time frame: Within 7 days after birth

    Clinical diagnosis (aerobic therapy or ventilator support + chest X-ray confirmation)

  17. Neonatal hypoglycemia

    Time frame: Within 24 hours after birth

    Blood glucose <2.6mmol/L (at least two tests are required for confirmation)

  18. The rate of newborns admitted to the NICU

    Time frame: From birth to discharge (or within 28 days after birth)

    Indications and days of transfer to the Neonatal Intensive Care Unit (NICU)

Sponsors and collaborators

Lead sponsor

Yan Lu

Other

Registry information

Official study title

Research on the Preventive Effect of Family-centered Early Nursing Intervention on High-risk Population of Gestational Diabetes Mellitus

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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