B-vitamin Levels and Adverse Pregnancy Outcomes

Sponsor

Westlake University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05073978

Collaborator

Beijing Obstetrics and Gynecology Hospital (Other)

15,000

Enrollment

Location

Anticipated Duration (Months)

834.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Birth Defect Pregnancy Loss Pregnancy Complications Pregnancy Induced Hypertension Recurrent Pregnancy Loss Health Problems in Pregnancy Gestational Diabetes Gestational Hypertension Preterm Birth	Other: No intervention

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 Design

Study Type:

Observational

Anticipated Enrollment :

15000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

The Association Between Niacin Deficiency and Birth Defects: a Case-control Study

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Case group Case group with certain pregnancy outcome, e.g., abortion, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc.	Other: No intervention This is an observational study without any intervention
Control group Control group without certain pregnancy outcome,e.g., abortion, stillbirth, preterm birth, and birth defects,gestational hypertension, gestational diabetes mellitus, etc.	Other: No intervention This is an observational study without any intervention

Arm

Intervention/Treatment

Case group

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

Other: No intervention

This is an observational study without any intervention

Control group

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

Other: No intervention

This is an observational study without any intervention

Outcome Measures

Primary Outcome Measures

fetal outcomes [at delivery]
Including intrauterine growth retardation,abortion, stillbirth, preterm birth, live birth
fetal outcomes [42 days after delivery]
Including birth defects
maternal outcomes [at delivery]
Including gestational hypertension, preeclampsia, gestational diabetes mellitus, hypothyroidism

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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