Clinical trial NCT05212519: Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes
Official title: Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GDM
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Whether suffering from gestational diabetes
timeFrame: 2022-1-1to2024-1-1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
affiliation: Beijing Friendship Hospital
name: min shang, MedicalPhD
role: PRINCIPAL_INVESTIGATOR
References: