NCT05824897

The Cohort Study of the Correlation Between Serum 25(OH)D Level and Pregnancy Outcome

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 171 (estimated)
• Sponsor: Aimin Zhao · Academic / Other
• Sex: Female
• Age: 20 Years
• Healthy volunteers: Accepted

Summary

The objective of this single-center prospective observational study is to clarify the trend of maternal serum 25(OH)D levels before pregnancy and during pregnancy, and to explore the correlation between serum 25(OH)D levels and subsequent pregnancy outcomes of patients with abortion, so as to provide certain scientific evidence for finding the optimal serum level of 25(OH)D and optimal vitamin D supplementation to maintain a healthy pregnancy.

Detailed description

Women of reproductive age who meet the inclusion criteria are recruited from the outpatient department of Renji Hospital from November 2022 to December 2023. Subjects fill in the basic information at the outpatient clinic. After being included in the study, peripheral blood is collected before and during the first trimester (\< 10 weeks), second trimester (22-24 weeks) and third trimester (32 weeks) to detect 25(OH)D, calcium, phosphorus and PTH levels. B-ultrasound examination is performed before pregnancy to record endometrial thickness, endometrial hemodynamic index (PI, RI and S/D) and uterine arterial hemodynamic index (PI, RI and S/D) during the luteal phase. Data are comprehensively analyzed through questionnaire form filling, laboratory examination, and clinical information records including pregnancy outcomes (final live birth rate, cesarean section rate, pregnancy loss rate, etc.), obstetric complications, and neonatal delivery information.

Conditions

• Vitamin D Deficiency
• Recurrent Miscarriage
• Pregnancy Related

Interventions

Type	Name	Description
OTHER	Serum levels of vitamin D	Subjects in this study are grouped according to baseline serum levels of 25(OH)D. The serum level of total 25(OH)D ≥30ng/ml (75nM) is sufficient, 20-30ng/ml (50-75 nm) is insufficient, and less than 20ng/ml (50nM) is deficient.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-12-31
• Completion: 2024-01-31
• First posted: 2023-04-24
• Last updated: 2023-04-24

Locations

1 site across 1 country: China