Actively Recruiting
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
Eligibility Criteria
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%.
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
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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