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

Gestational Weight Gain Clinical Trial

Official title:

Establishment of Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China: a Multicenter Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04744714
• Other study ID #: GWG2021
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Zhaoxia Liang, M.D.
• Phone: 86571-87061501
• Email: xiaozaizai[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Weight Gain
• Weight Gain

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal outcomes	Including pregnancy-induced hypertension, preterm delivery, abortion, delivery way and so on. They are diagnosed by clinicians and the data is gathered from medical records.	Through delivery completion, up to 40 weeks
Primary	Neonatal outcomes	Birth weight(in gram), birth height (in centimetre), gestational week (in week) and so on. They are diagnosed by clinicians and the data is gathered from medical records.	Through delivery completion, up to 40 weeks
Secondary	glucose metabolism index	OGTT results (mmol/L), HbA1c (%) and so on	postpartum 42 days
Secondary	offspring	weight (in gram), height (in centimetre), feeding situation (breast feeding or artificial feeding) and so on.	postpartum 42 days
Secondary	annual follow-up results	Annual questionnaire and physical examination, including weight (in kilogram), height (in metre), disease history, diet surveys and so on.	1 or 2 years after delivery