Clinical trial NCT05824897: The Cohort Study of the Correlation Between Serum 25(OH)D Level and Pregnancy Outcome
Official title: The Cohort Study of the Correlation Between Serum 25(OH)D Level and Pregnancy Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitamin D Deficiency
Recurrent Miscarriage
Pregnancy Related
Keywords: vitamin D
pregnancy
recurrent spontaneous abortion
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 171
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of childbearing age who are ready to become pregnant or already pregnant.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* ≥20 years old
* The chromosome karyotype of the couple is normal
* Color ultrasound examination results indicated that there was no organic disease related to reproductive tract
* No serious complications of surgery and medicine
* Agree and voluntarily sign informed consent

Exclusion Criteria:

* There are contraindications to pregnancy
* the initiative to give up pregnancy
* Severe medical and surgical complications, for example, liver disease was defined as serum alanine aminotransferase \[ALT\] or aspartic aminotransferase \[AST\]\>3 x upper normal limit \[ULN\] after repeated testing
* Concomitant malignant tumor, malignant tumor developed in the last 5 years (except for the skin squamous basal cell carcinoma that has been removed and considered cured). Subjects who developed malignant tumors more than 5 years ago should provide evidence of remission or cure. Subjects with a history of cervical cancer were eligible if they could demonstrate that their cervical cancer had been cone removed or cured within the past 3 years
* Known human immunodeficiency virus (HIV) positive and/or hepatitis B surface antigen or hepatitis C virus antibody positive at screening visit
* With a history of chronic infections such as mycoplasma, chlamydia, cryptococcus, and invasive fungal infections should be discussed with the principal investigator

Primary outcomes:
measure: pregnancy loss
timeFrame: Up to 28 weeks
Secondary outcomes:
measure: Live birth
timeFrame: Up to 20 weeks
measure: Premature birth
timeFrame: 9 weeks
measure: Preeclampsia
timeFrame: 20 weeks
measure: Gestational diabetes mellitus
timeFrame: 4 weeks
measure: Fetal growth restriction
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Aimin Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References: