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

Recruiting

• Conditions: Gestational Weight Gain

• Registration Number: NCT04744714
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

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.

Study Timeline

• Study First Submitted: 2021-01-27
• Study Start: 2021-02-01
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-19
• Last Update Posted: 2023-02-21
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 10000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal outcomes	Through delivery completion, up to 40 weeks	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.
Neonatal outcomes	Through delivery completion, up to 40 weeks	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.

Secondary Outcome Measures

Name	Time	Method
glucose metabolism index	postpartum 42 days	OGTT results (mmol/L), HbA1c (%) and so on
offspring	postpartum 42 days	weight (in gram), height (in centimetre), feeding situation (breast feeding or artificial feeding) and so on.
annual follow-up results	1 or 2 years after delivery	Annual questionnaire and physical examination, including weight (in kilogram), height (in metre), disease history, diet surveys and so on.

Trial Locations

Locations (1)

Women's Hospital School of Medicine Zhejiang University; 🇨🇳 Hangzhou, China