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

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ClinicalTrials.gov Identifier: NCT02737644
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Congenital Heart Disease Other: observation

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.

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Study Type : Observational
Estimated Enrollment : 60000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Peri-conception Key Nutritional Factors and Primary Prevention of Congenital Heart Disease(CHD)
Study Start Date : March 2016
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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 Name: This is an observational study




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Venous Blood


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737644


Contacts
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Contact: Wei L Yan, PHD 86 21 64931215 ext 86 21 64931215 yanwl@fudan.edu.cn
Contact: Ying G Huang, MD PHD 86-21-64931928 ext 86-21-64931913 gyhuang@shmu.edu.cn

Locations
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China, Shanghai
Children Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Guoying Huang    (21)64931928    gyhuang@shmu.edu.cn   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Chair: Ying G Huang, PHD Children's Hospital of Fudan University

Publications of Results:
Other Publications:
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02737644     History of Changes
Other Study ID Numbers: GWIV24_v1
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Children's Hospital of Fudan University:
Congenital Heart Disease
Key Nutritional Factors
conception
pregnant
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities