B-vitamin Levels and Adverse Pregnancy Outcomes

Completed

• Conditions: Pregnancy Loss; Pregnancy Complications; Gestational Hypertension; Birth Defect; Health Problems in Pregnancy; Pregnancy Induced Hypertension; Recurrent Pregnancy Loss; Gestational Diabetes; Preterm Birth
• Interventions: Other: No intervention

• Registration Number: NCT05073978
• Lead Sponsor: Westlake University

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

Detailed Description

Folate deficiency can cause severe adverse pregnancy outcomes, such as neural tube defects. Effective folate functioning requires essential metabolic interactions with other B vitamins including vitamin B2, vitamin B3, vitamin B6, and vitamin B12, which can also influence pregnancy outcomes independently. For example, animal and family studies have identified that niacin (B3) deficiency can lead to congenital malformations. However, how folate and related B-vitamin levels interact with each other while affecting various pregnancy outcomes including abortion, birth defects, pregnancy complications, etc. is unclear. Besides, folate levels in previous studies were mostly measured in plasma which are easily influenced by dietary factors, instead of red blood cell folate which can reflect the long-term status. Moreover, the difference in the risk of neural tube defects across a range of maternal red blood cell folate concentrations has been largely ignored. Using data of pregnant women recruited at Beijing Obstetrics and Gynecology Hospital from December 2020 to December 2021, this case-control study aims to examine the association of folate and related B-vitamin levels in first-trimester blood samples (plasma and red blood cell) with pregnancy outcomes, particularly the association between niacin deficiency and birth defects.

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-11
• Study First Posted: 2021-10-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7500

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	No intervention	Control group without certain pregnancy outcome,e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc.
Case group	No intervention	Case group with certain pregnancy outcome, e.g., miscarriage, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc.

Primary Outcome Measures

Name	Time	Method
fetal outcomes	42 days after delivery	Including birth defects
maternal outcomes	at delivery	Including gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital; 🇨🇳 Beijing, Beijing, China