Peri-conception Key Nutritional Factors and Congenital Heart Disease

NCT02737644 | Completed DMC

• 1 other identifier: GWIV24_v1
• Study Type: observational
• Target: 37,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease; Key Nutritional Factors; conception; pregnant

Outcome Measures

Primary Outcomes (1)

• preconceptional maternal serum folate level

  a serum sample collected at preconception and/or early conception will be used for examination

  usually 6 months before pregnancy

Secondary Outcomes (6)

• early conceptional maternal serum folate deficiency

  first antenatal visit (usually 12th-16th gestational week)

• The status of serum Vitamin D level

  periconception period ( defined as around 6 months before and the first 3 months of gestation

• Pre-conceptional maternal diet folic acid supplement intake

  preconception examination (usually 0-6 months before pregnancy)

• Peri-conceptional maternal plasma homocysteine level

  peri-conception examination ( defined as about 6 months before and 3 months after conception

• neonatal congenital heart disease(CHD) status

  Congenital heart disease screening during 6-72 hours after delivery

Study Arms (1)

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

Interventions

observation OTHER

This is an observational study

Also known as: This is an observational study

CHD birth cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (6)

• 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.

  PMID: 18657826 BACKGROUND

• 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.

  PMID: 19436079 RESULT

• 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.

  PMID: 25059817 RESULT

• Chen X, Zhang Y, Chen H, Dou Y, Wang Y, He W, Ma X, Sheng W, Yan W, Huang G. Association Between Serum Glycated Hemoglobin Levels at Early Gestation and the Risk of Subsequent Pregnancy Loss in Pregnant Women Without Diabetes Mellitus: Prospective Cohort Study. JMIR Public Health Surveill. 2023 Dec 12;9:e46986. doi: 10.2196/46986.

  PMID: 38085559 DERIVED

• Chen H, Zhang Y, Wang D, Chen X, Li M, Huang X, Jiang Y, Dou Y, Wang Y, Ma X, Sheng W, Jia B, Yan W, Huang G; SPCC (Shanghai Preconception Cohort) Group. Periconception Red Blood Cell Folate and Offspring Congenital Heart Disease : Nested Case-Control and Mendelian Randomization Studies. Ann Intern Med. 2022 Sep;175(9):1212-1220. doi: 10.7326/M22-0741. Epub 2022 Aug 23.

  PMID: 35994746 DERIVED

• Wang D, Zhang Y, Jiang Y, Ye Y, Ji M, Dou Y, Chen X, Li M, Ma X, Sheng W, Huang G, Yan W; SPCC group. Shanghai Preconception Cohort (SPCC) for the association of periconceptional parental key nutritional factors with health outcomes of children with congenital heart disease: a cohort profile. BMJ Open. 2019 Nov 24;9(11):e031076. doi: 10.1136/bmjopen-2019-031076.

  PMID: 31767586 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Venous Blood

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Observation

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Ying G Huang, PHD

  Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2016
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Locations

CN (1)