B-vitamin Levels and Adverse Pregnancy Outcomes

NCT05073978 | Completed DMC

• 1 other identifier: 20210119SHJ001
• Study Type: observational
• Target: 7,500
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective nested case-control study aims to examine the effects of blood vitamin B levels in first-trimester pregnant women on the pregnancy outcomes

Conditions

Birth Defect; Pregnancy Loss; Pregnancy Complications; Pregnancy Induced Hypertension; Recurrent Pregnancy Loss; Health Problems in Pregnancy; Gestational Diabetes; Gestational Hypertension; Preterm Birth

Keywords

vitamin B; pregnancy outcome

Outcome Measures

Primary Outcomes (3)

• fetal outcomes

  Including intrauterine growth retardation,abortion, stillbirth, preterm birth, live birth

  at delivery

• fetal outcomes

  Including birth defects

  42 days after delivery

• maternal outcomes

  Including gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism

  at delivery

Study Arms (2)

Case group

Case group with certain pregnancy outcome, e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc.

Other: No intervention

Control group

Control group without certain pregnancy outcome,e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc.

Other: No intervention

Interventions

No intervention OTHER

This is an observational study without any intervention

Case group; Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

all pregnant women recruited in the birth cohort of Beijing Obstetrics and Gynecology Hospital between 2020.12 to 2021.12

You may qualify if:

• Pregnant women with 6-13(+6 days) gestational weeks
• Resided in Beijing in the past year
• Pregnant women who intend to have antenatal examinations and delivery at Beijing Obstetrics and Gynecology Hospital
• Pregnant women who are willing to participate in this study with informed consent

You may not qualify if:

• Women with Hepatitis B, syphilis, HIV/AIDS and other infectious diseases.

Sponsors & Collaborators

• Westlake University: lead
• Beijing Obstetrics and Gynecology Hospital: collaborator

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital

Beijing, Beijing Municipality, 100020, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

first-trimester maternal blood

MeSH Terms

Conditions

Congenital Abnormalities; Pregnancy Complications; Hypertension, Pregnancy-Induced; Diabetes, Gestational; Premature Birth

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Hongjun Shi, PhD

  Westlake University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 12, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

CN (1)