Peri-conception Key Nutritional Factors and Congenital Heart Disease (PKNFCHD)

March 9, 2021 updated by: Children's Hospital of Fudan University

Peri-conception Key Nutritional Factors and Primary Prevention of Congenital Heart Disease(CHD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

37000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All couples attending pre-pregnancy physical examination from 11 districts in Shanghai from March 2016, or pregnant women present at first antenatal care < 14 week of gestation

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: observation
This is an observational study
Other Names:
  • This is an observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
usually 6 months before pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
first antenatal visit (usually 12th-16th gestational week)
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
periconception period ( defined as around 6 months before and the first 3 months of gestation
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
preconception examination (usually 0-6 months before pregnancy)
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
peri-conception examination ( defined as about 6 months before and 3 months after conception
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.
Congenital heart disease screening during 6-72 hours after delivery
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
usually between 0-6 months before and 3 months after conception)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Chair: Ying G Huang, PHD, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

December 30, 2020

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GWIV24_v1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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