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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observation | Other | This is an observational study |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| early conceptional maternal serum folate deficiency | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Ying G Huang, PHD | Children's Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18657826 | Background | 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. | |
| 19436079 | Result | 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. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Venous Blood
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 | 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 | 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 | 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 | 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) |
| 25059817 | 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. |
| 38085559 | Derived | 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. |
| 35994746 | 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. |
| 31767586 | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |