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Early Nursing InterventionNCT06997835

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

A study testing Intervention group：Family-centered early care intervention in people with Early Nursing Intervention and Gestational Diabetes Mellitus, run by Yan Lu at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
Intervention group：Family-centered early care intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 Jan 2025to 30 Sep 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • Phentolamine
  • Diuretics (e.g., furosemide, hydrochlorothiazide)
  • Phenytoin
  • Systemic corticosteroids (e.g., cortisone, prednisone)
  • Activity-limiting comorbidities:
  • Severe medical complications contraindicating physical activity (e.g., unstable angina, advanced respiratory failure)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nantong First People's Hospital

    Nantong, Jiangsu, 226001

Other trials in China

About this study

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

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.

Being tested
Control group：The interactive management nursing model on the wechat platform, Intervention group：Family-centered early care intervention
Keywords
Gestational diabetes mellitus
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control group：The interactive management nursing model on the wechat platformBehavioural

    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 interventionBehavioural

    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.
Study groups in NCT06997835
Study groupRoleWhat they receive
Control groupExperimentalNot described
Receives: Behavioral: Control group：The interactive management nursing model on the wechat platform
Intervention groupExperimentalNot described
Receives: Behavioral: Intervention group：Family-centered early care intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of gestational diabetes

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

    Measured: 24 weeks of gestation

Secondary outcomes (18)

  1. Blood sugar status of pregnant women

    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)

    Measured: 24 weeks of gestation

  2. The weight gain of pregnant women during pregnancy

    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.

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

  3. Gestational weeks at delivery

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

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

  4. Complications during pregnancy

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

    Measured: From enrollment to delivery

  5. Polyhydramnios

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

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

  6. Postpartum complications

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

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

  7. Mode of delivery

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

    Measured: Records during childbirth

  8. Premature rupture of membranes

    Clinical diagnosis of natural rupture of membranes before labor

    Measured: Pregnancy ≥37 weeks until before delivery

  9. The length and cost of hospital stay after delivery

    Length of hospital stay (days) and total cost

    Measured: From delivery to discharge

  10. Fetal growth restriction

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

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

  11. Macrosomia

    Birth weight ≥4000g

    Measured: Records during childbirth

  12. Premature birth

    The gestational age at delivery is less than 37 weeks

    Measured: From enrollment to delivery

  13. Stillbirth

    Fetal death occurs after ≥20 weeks of pregnancy

    Measured: From enrollment to delivery

  14. Fetal malformation

    Congenital malformations confirmed by ultrasound or clinically after birth

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

  15. Fetal distress

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

    Measured: Records during childbirth

  16. Neonatal respiratory distress syndrome

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

    Measured: Within 7 days after birth

  17. Neonatal hypoglycemia

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

    Measured: Within 24 hours after birth

  18. The rate of newborns admitted to the NICU

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2025
  2. Study start1 Jan 2025
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997835
Sponsor's protocol ID
2025XM105
Status last verified
May 2025
First submitted
14 May 2025
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group：Family-centered early care intervention in people with Early Nursing Intervention and Gestational Diabetes Mellitus, run by Yan Lu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of gestational diabetes (time frame: 24 weeks of gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06997835.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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