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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Weight Gain

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GDM group<br>questionnaire survey and clinical follow-up | |
| non-GDM group<br>questionnaire survey and clinical follow-up | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose metabolism index | OGTT results (mmol/L), HbA1c (%) and so on | postpartum 42 days | 
| offspring | weight (in gram), height (in centimetre), feeding situation (breast feeding or artificial feeding) and so on. | postpartum 42 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational weight gain, gestational diabetes mellitus