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.
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.
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.
First Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
First People's Hospital of Foshan
Collaborator
Jiangmen Maternity and Child Health Care Hospital
Collaborator
Panyu Maternal And Child Care Service Centre Of Guangzhou
Collaborator
The Affiliated Shunde Hospital of Jinan University
Collaborator
Shenzhen Second People's Hospital
Collaborator
BoAi Hospital of Zhongshan
Collaborator
Yuebei People's Hospital
Collaborator
Qingyuan People's Hospital
Collaborator
The Sixth Affliated Hospital of Jinan University
Collaborator
Baoan Maternal And Child Health Care Hospital, Shenzhen, China
Collaborator
Jiangxi Maternal and Child Health Hospital
Collaborator
Guangxi provincial maternal and chidren's hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Obstetrics and Gynecology Hospital of Zhejiang University
Collaborator
Xiangya Hospital of Central South University
Collaborator
Guangzhou Women's and Children's Hospital
Collaborator