Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
NCT06767722

Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial

Led by First Affiliated Hospital, Sun Yat-Sen University · Updated on 2025-07-01

3430

Participants Needed

1

Research Sites

115 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital, Sun Yat-Sen University

Lead Sponsor

F

First People's Hospital of Foshan

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age.
  • Able to provide informed consent.
  • Confirmed viable singleton pregnancy by nuchal translucency scan between 11+0 and 13+6 weeks.
  • Abnormal glucose metabolism before 14 weeks defined as fasting plasma glucose 5.1-6.9 mmol/L and/or hemoglobin A1c 5.7%-6.4%.
Not Eligible

You will not qualify if you...

  • Diagnosed pregestational diabetes or fasting plasma glucose ≥7.0 mmol/L or hemoglobin A1c ≥6.5% at first prenatal visit.
  • Plan to terminate pregnancy due to fetal anomaly found in first trimester scan.
  • Use of medications affecting glucose metabolism at randomization (e.g., corticosteroids, antipsychotics).
  • Serious physical or psychological conditions interfering with trial participation.
  • Current hyperemesis gravidarum causing dehydration or requiring hospitalization unless resolved by 14+6 weeks gestation.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Sun Yatsen University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

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Research Team

H

Haitian Chen, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Effectiveness of a Lifestyle Intervention for Pregnant Women With Abnormal Glucose Metabolism in Early Pregnancy: EAGM Trial | DecenTrialz