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

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency; Pregnancy Related; Recurrent Miscarriage
• Intervention / Treatment: Other: Serum levels of vitamin D

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.

• Study Type: Observational
• Enrollment (Anticipated): 171

Contacts and Locations

• Study Contact: Name: Renyi Zhou; Phone Number: 86-15151561775; Email: klyjzrysfmyn@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Renyi Zhou; Phone Number: 86-15151561775; Email: klyjzrysfmyn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women of childbearing age who are ready to become pregnant or already pregnant.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy loss	After a positive urinary hCG pregnancy test at home or clinically, there were no clinical signs of pregnancy on subsequent ultrasound or signs of pregnancy were lost after ultrasound confirmation.	Up to 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth	A live baby born after 23 weeks of gestation	Up to 20 weeks
Premature birth	Delivery between 28 and 37 weeks gestation	9 weeks
Preeclampsia	New hypertension (blood pressure greater than 140/90 mmHg) after 20 weeks of gestation combined with new unexplained urinary protein greater than or equal to 300mg/24h or a urinary protein/creatinine ratio greater than or equal to 0.3 or other conditions	20 weeks
Gestational diabetes mellitus	Perform a 75-g OGTT with plasma glucose measurement when patient is fasting and at 1 and 2 h, at 24-to-28-wk gestation in women not previously diagnosed with overt diabetes The diagnosis of GDM is made when any one of the following plasma glucose values are met or exceeded: Fasting: 92 mg/dL; h: 180 mg/dL; h: 153 mg/dL	4 weeks
Fetal growth restriction	Fetal weight below the 10th percentile of the mean weight for its gestational age or below 2 standard deviations of the mean weight	Up to 28 weeks

Collaborators and Investigators

• Sponsor: Aimin Zhao
• Investigators: Principal Investigator: Aimin Zhao, MD, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 21, 2023
• First Posted (Actual): April 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy; vitamin D; recurrent spontaneous abortion
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Pregnancy Complications; Vitamin D Deficiency; Abortion, Spontaneous; Abortion, Habitual; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: IIT-2023-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No