Peri-conception Key Nutritional Factors and Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease
• Interventions: Other: observation

• Registration Number: NCT02737644
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-03
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-14
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CHD birth cohort	observation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
early conceptional maternal serum folate deficiency	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	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	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	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	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	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

Trial Locations

Locations (1)

Children Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China