Peri-conception Key Nutritional Factors and Congenital Heart Disease

Overview

The study is a nested case-control study and the purpose is to describe the status of key nutrients(eg.folic acid and vitamins) supplementation among pregnant women in Shanghai, to find out the association between the level of serum key nutrients during peri-conceptional period and the incidence of congenital heart defects (CHD) in newborn, and to provide better preconception care.

Full Title of Study: “Peri-conception Key Nutritional Factors and Primary Prevention of Congenital Heart Disease(CHD)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 30, 2020

Detailed Description

Congenital heart defects (CHD) are among the most common major congenital anomalies with an incidence of about 8-12/1,000 live births worldwide. The mechanism of CHD is still unclear. Many studies indicated that the level of key nutrients (eg.folic acid and vitamins) during peri-conceptional period might affect the incidence of CHD, but the evidence is limited. The study aimed to explore the association between serum key nutrients during peri-conceptional period and the incidence of CHD in newborn. All couples attending pre-pregnancy physical examination from 11 districts (Minhang District, Huangpu District, Xuhui District, Changning District, Jingan District, Putuo District, Yangpu District, Jiading District, Pudong District,Songjiang District, Qingpu District) in Shanghai from March 2016, are recruited and their blood samples and questionnaires about the supplementation of key nutrients are collected. During the gestation, venous blood of pregnant women at all of three trimesters is taken. Besides, questionnaires about the supplementation of key nutrients at the first antenatal visit are also obtained. The level of serum folic acid, vitamin A and vitamin B12 at preconception and during gestation are measured. Finally, investigators identifies those whose newborns developed CHD during follow-up as the cases. Then, investigators selects four controls for each case from the rest of the cohort by matching on constitutional determinants of CHD such as age and sex. Participants are identified by national identification number during the follow up. The level of serum key nutrients is compared in cases and controls. Univariate and multivariate association analyses will be performed to identify risk factors to CHD by using multivariate logistic regression model.

Interventions

  • Other: observation
    • This is an observational study

Arms, Groups and Cohorts

  • CHD birth cohort
    • Cases are identified as those whose newborns screened and confirmed with CHD during the follow-up and four age- and delivery-hospital matched controls are selected for each case from the rest of the cohort.

Clinical Trial Outcome Measures

Primary Measures

  • preconceptional maternal serum folate level
    • Time Frame: usually 6 months before pregnancy
    • a serum sample collected at preconception and/or early conception will be used for examination

Secondary Measures

  • early conceptional maternal serum folate deficiency
    • Time Frame: first antenatal visit (usually 12th-16th gestational week)
    • a serum sample collected at early conception will be used for examination
  • The status of serum Vitamin D level
    • Time Frame: periconception period ( defined as around 6 months before and the first 3 months of gestation
    • a serum sample collected at preconception and/or first antenatal visit will be used for examination
  • Pre-conceptional maternal diet folic acid supplement intake
    • Time Frame: preconception examination (usually 0-6 months before pregnancy)
    • a questionnaire administered at preconception and early conception will be used for estimation based on the dose and frequency of supplements intake
  • Peri-conceptional maternal plasma homocysteine level
    • Time Frame: peri-conception examination ( defined as about 6 months before and 3 months after conception
    • a plasma sample collected at preconception and first antenatal visit will be used for examination
  • neonatal congenital heart disease(CHD) status
    • Time Frame: Congenital heart disease screening during 6-72 hours after delivery
    • The newborn babies with heart murmurs(≥ 2 grade) and subnormal Pulse Oximetry reading positive will be considered positive-screened and echocardiography will performed.
  • Peri-conceptional paternal serum folate level
    • Time Frame: usually between 0-6 months before and 3 months after conception)
    • a serum sample collected at preconception and/or early conception will be used for examination

Participating in This Clinical Trial

Inclusion Criteria

  • attend pre-pregnancy physical examination from 11 districts in Shanghai, OR pregnant women present at first antenatal care < 14 week of gestation – plan to deliver in Shanghai Exclusion Criteria:

  • none

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Fudan University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ying G Huang, PHD, Study Chair, Children’s Hospital of Fudan University

References

Reller MD, Strickland MJ, Riehle-Colarusso T, Mahle WT, Correa A. Prevalence of congenital heart defects in metropolitan Atlanta, 1998-2005. J Pediatr. 2008 Dec;153(6):807-13. doi: 10.1016/j.jpeds.2008.05.059. Epub 2008 Jul 26.

Citations Reporting on Results

Ionescu-Ittu R, Marelli AJ, Mackie AS, Pilote L. Prevalence of severe congenital heart disease after folic acid fortification of grain products: time trend analysis in Quebec, Canada. BMJ. 2009 May 12;338:b1673. doi: 10.1136/bmj.b1673.

Peyvandi S, Rychik J, Zhang X, Shea JA, Goldmuntz E. Preconceptual Folic Acid Use and Recurrence Risk Counseling for Congenital Heart Disease. Congenit Heart Dis. 2015 May-Jun;10(3):219-25. doi: 10.1111/chd.12206. Epub 2014 Jul 24.

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