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

NCT04744714 | Unknown

• 1 other identifier: GWG2021
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Weight Gain

Keywords

gestational weight gain; gestational diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• glucose metabolism index

  postpartum 42 days

• offspring

  postpartum 42 days

• annual follow-up results

  1 or 2 years after delivery

Study Arms (2)

GDM group

questionnaire survey and clinical follow-up

non-GDM group

questionnaire survey and clinical follow-up

Eligibility Criteria

• Age: 20 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine, tissue (placenta and umbilical cord)

MeSH Terms

Conditions

Gestational Weight Gain; Diabetes, Gestational

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Zhaoxia Liang, M.D.

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaoxia Liang, M.D.

CONTACT

86571-87061501; xiaozaizai@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 9, 2021
• Study Start: February 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

CN (1)