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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04744714
Enrollment
10000
Registered
2021-02-09
Start date
2021-02-01
Completion date
2024-12-31
Last updated
2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Weight Gain

Keywords

gestational weight gain, gestational diabetes mellitus

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.

Interventions

None listed

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 49 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Maternal outcomesThrough delivery completion, up to 40 weeksIncluding 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 outcomesThrough delivery completion, up to 40 weeksBirth 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

MeasureTime frameDescription
glucose metabolism indexpostpartum 42 daysOGTT results (mmol/L), HbA1c (%) and so on
offspringpostpartum 42 daysweight (in gram), height (in centimetre), feeding situation (breast feeding or artificial feeding) and so on.
annual follow-up results1 or 2 years after deliveryAnnual questionnaire and physical examination, including weight (in kilogram), height (in metre), disease history, diet surveys and so on.

Countries

China

Contacts

Primary ContactZhaoxia Liang, M.D.
xiaozaizai@zju.edu.cn86571-87061501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026