Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes

GDM Clinical Trial

Official title:

Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05212519
• Other study ID #: rszqwssdspyrsqtnbjrsjjdxgx
• Status: Enrolling by invitation
• Start date: January 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2022
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Explore the specific correlation between different concentration levels of vitamin D in early pregnancy and blood glucose levels at each time node of OGTT, the correlation between different concentrations of vitamin D levels and A1 and A2 diabetes in pregnancy, and the impact on maternal and infant outcomes , And provide a basis for the prevention and treatment of GDM.

Description:

1. According to the diagnostic criteria of GDM proposed by the International Association for the Study of Diabetes and Pregnancy (IADPSG), the 18-45-year-old pregnant women who were filed and delivered by the Obstetrics Department of Beijing Friendship Hospital from September 2022 to September 2024 were selected to collect their early pregnancy (pregnancy 1- 3 months) Vitamin d level, divided into three groups: A (<20 ng/ml), B (20~<30 ng/ml), and C (≥30 ng/ml), compare the early pregnancy (1-3 months of pregnancy) Differences in vitamin D levels.

2. Follow-up patients with gestational diabetes mellitus are divided into type A1 gestational diabetes patients (GDM 1 group) and type A2 gestational diabetes patients (GDM 2 group) according to whether participant are treated with insulin, and study vitamins through multiple linear and logistic regression models The relationship between D level and GDM and follow-up pregnancy outcome

3. Analyze the relationship between the level of vitamin D in early pregnancy and pregnancy complications, such as whether it is combined with premature rupture of membranes, hypertension during pregnancy, whether it is a cesarean section, whether it is a giant baby, whether there is asphyxia in newborns, etc.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Pregnant women aged 18 to 45 years who have received regular antenatal examinations and delivered in the department of obstetrics in Beijing Friendship Hospital, Capital Medical University.

Exclusion Criteria:

(1) chronic or acute disease history (diabetes mellitus, hypertension,or thyroid disease); (2) any mental disorder; (3) abortion (fetal loss before 28 gestational weeks); (4)multiple fetuses; (5) planning to give birth in other hospitals.

Related Conditions & MeSH terms

• Diabetes, Gestational
• GDM

Locations

Country	Name	City	State
China	Beijing Friendship Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Min Shang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether suffering from gestational diabetes	Low vitamin D levels are more likely to develop diabetes	2022-1-1to2024-1-1