Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China

NCT ID: NCT04744714

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-12-31

Brief Summary

Appropriate gestational weight gain (GWG) is a key factor in balancing maternal and neonatal needs of nourishment and health, which is especially important in women with gestational diabetes mellitus (GDM). However, there are no specific guidelines for GWG in Chinese pregnant women and even for GDM pregnant women.This project intends to fill in the gaps of this field through multi-center large sample prospective cohort study.

Detailed Description

Inappropriate gestational weight gain (GWG) is an important risk factor affecting adverse pregnancy outcomes. However, the current guidelines for GWG are based on American population and may not apply to pregnant women in China, especially for those with gestational diabetes mellitus (GDM) who have high risk factors. The big gaps in academic-related fields need to be filled.

Our research group has previously found the heterogeneous relationships between GWG and adverse outcomes in GDM women with different abnormal glucose metabolism. Therefore, based on the principles of precision medicine, this project intends to establish for the first time the GWG standard for Chinese pregnant women to optimize the GWG management through a multicenter prospective cohort study. At the same time, specific GWG guidelines applicable to GDM women with different glucose metabolism abnormalities were innovatively constructed. Our study will provide strong evidence for stratified management and precise intervention of GDM pregnant women, which is of great significance to ensure health of both mothers and their offspring.

Conditions

Gestational Weight Gain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GDM group

questionnaire survey and clinical follow-up

No interventions assigned to this group

non-GDM group

questionnaire survey and clinical follow-up

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Maternal age: 20-49 years;
• Natural conception;
• Single pregnancy;
• Plan to have routine prenatal examinations and give birth in the research center;
• No plan to move within two years;
• No second pregnancy within two years;
• Willing to cooperate with the hospital to follow up after childbirth.

Exclusion Criteria

• Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, heart disease, liver and kidney diseases, thyroid diseases, autoimmune diseases, malignant tumors, AIDS, etc.;
• Assisted reproduction;
• Multiple pregnancy;
• Fetus has a known deformity or genetic defects;
• Incomplete clinical data.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaoxia Liang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Women's Hospital School Of Medicine Zhejiang University

Locations

Women's Hospital School of Medicine Zhejiang University

Hangzhou, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhaoxia Liang, M.D.

Role: CONTACT

xiaozaizai@zju.edu.cn

86571-87061501

Facility Contacts

Zhaoxia Liang, M.D.

Role: primary

xiaozaizai@zju.edu.cn

86571-87061501

Other Identifiers

GWG2021

Identifier Type: -

Identifier Source: org_study_id