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

Study acronym: EAGM
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Jan 1, 2025 to Apr 16, 2025
    • Study sites: 0 to 1
    • Collaborators: 13 to 16
    • Study title shortened, about 2 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06767722
Lead Sponsor First Affiliated Hospital, Sun Yat-Sen University
Collaborators: First People's Hospital of Foshan, Jiangmen Maternity and Child Health Care Hospital, Panyu Maternal And Child Care Service Centre Of Guangzhou, The Affiliated Shunde Hospital of Jinan University, Shenzhen Second People's Hospital, BoAi Hospital of Zhongshan, Yuebei People's Hospital, Qingyuan People's Hospital, The Sixth Affliated Hospital of Jinan University, Baoan Maternal And Child Health Care Hospital, Shenzhen, China, Jiangxi Maternal and Child Health Hospital, Guangxi provincial maternal and chidren's hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Women's Hospital School Of Medicine Zhejiang University, Xiangya Hospital of Central South University, Guangzhou Women's and Children's Hospital
Conditions
(from sponsor)		 Early Pregnancy, Fasting Plasma Glucose, Hemoglobin A1c Protein, Human, Lifestyle Intervention, Adverse Pregnancy Outcomes
Enrollment 3,430 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov