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

NCT05824897 | Unknown

• 1 other identifier: IIT-2023-0011
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Recurrent Miscarriage; Pregnancy Related

Keywords

vitamin D; pregnancy; recurrent spontaneous abortion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Live birth

  Up to 20 weeks

• Premature birth

  9 weeks

• Preeclampsia

  20 weeks

• Gestational diabetes mellitus

  4 weeks

• Fetal growth restriction

  Up to 28 weeks

Interventions

Serum levels of vitamin D OTHER

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.

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Women of childbearing age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aimin Zhao: lead

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Abortion, Habitual; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aimin Zhao, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renyi Zhou

CONTACT

86-15151561775; klyjzrysfmyn@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 24, 2023
• Study Start: November 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)