NCT06767722 Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial
| NCT ID | NCT06767722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University |
| Condition | Early Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,430 participants |
| Start Date | 2025-04-16 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,430 participants in total. It began in 2025-04-16 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicentre, parallel-group, open-label, pragmatic, randomised-control trial of early lifestyle intervention versus routine prenatal care by random allocation (1:1) in women with early abnormal glucose metabolism (EAGM) to compare the incidence of large-gestational age and preterm birth between two groups. The investigators aim to assess the effectiveness of early lifestyle interventions and to provide evidence for the optimal standard management for Chinese women with EAGM.
Eligibility Criteria
Inclusion Criteria: * Over 18 years of age. * Able to provide informed consent. * Confirmed viable pregnancy on a nuchal translucency scan done between 11+0 and 13+6 weeks. * Singleton pregnancies. * An abnormal glucose metabolism determined by a blood test performed before 14 weeks, defined as FPG 5.1-6.9mmol/L and/or HbA1c 5.7-6.4%. Exclusion Criteria: * Pregestational diabetes (diagnosed as diabetes mellitus before pregnancy, or FPG≥7.0mmol/L, or HbA1c≥6.5% at the first prenatal visit), impaired fasting glucose or impaired glucose tolerance diagnosed before pregnancy. * Plan for termination of pregnancy due to fetal anomaly identified at the first trimester scan. * Use of medications known to interfere with glucose metabolism (e.g. corticosteroids, antipsychotic drugs) at the time of randomisation. * Any other physical (serious medical conditions such as cancer, organ failure, epilepsy, paraplegia, disability) or psychological condition (e.g. learning difficulties, serious mental illness) that is likely to interfere with the conduct of the trial according to evaluation by the trial monitoring group. * Women currently with hyperemesis gravidarum leading to dehydration or requiring hospitalization. If persisting vomiting resolves, the patient may be reassessed for inclusion in the trial up to and including 14+6 weeks of gestation, providing all other inclusion and exclusion criteria are met.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06767722 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 55 Years, studying Early Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06767722 currently recruiting?
Yes, NCT06767722 is actively recruiting participants. Contact the research team at chhait@mail.sysu.edu.cn for enrollment information.
Where is the NCT06767722 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06767722 clinical trial?
NCT06767722 is sponsored by First Affiliated Hospital, Sun Yat-Sen University. The trial plans to enroll 3,430 participants.