Clinical trial NCT04744714: Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China
Official title: Establishment of Gestational Weight Gain Criteria for Pregnant Women With Gestational Diabetes Mellitus in China: a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Weight Gain
Keywords: gestational weight gain
gestational diabetes mellitus
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 10000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This project intends to recruit pregnant women who go to the research center for routine prenatal examination and OGTT screening.

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.

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.

Primary outcomes:
measure: Maternal outcomes
timeFrame: Through delivery completion, up to 40 weeks
measure: Neonatal outcomes
timeFrame: Through delivery completion, up to 40 weeks
Secondary outcomes:
measure: glucose metabolism index
timeFrame: postpartum 42 days
measure: offspring
timeFrame: postpartum 42 days
measure: annual follow-up results
timeFrame: 1 or 2 years after delivery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Zhaoxia Liang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: