Skip to main content
OpenTrials
Completed

NCT Number: NCT02737644

Peri-conception Key Nutritional Factors and Congenital Heart Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observation

Other

This is an observational study

Other names: This is an observational study

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Acronym: PKNFCHD

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2016
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.