Bortolus R^{1<\/sup>,\u00a0Blom F,\u00a0Filippini F,\u00a0van Poppel MN,\u00a0Leoncini E,\u00a0de Smit DJ,\u00a0Benetollo PP,\u00a0Cornel MC,\u00a0de Walle HE,\u00a0Mastroiacovo P;Italian and Dutch\u00a0folic acid\u00a0trial study groups.<\/p>\n}

BACKGROUND:<\/h4>\n
In 2010 a Cochrane review confirmed that\u00a0folic acid\u00a0(FA) supplementation prevents the first- and second-time occurrence of neural tube defects (NTDs). At present some evidence from observational studies supports the hypothesis that FA supplementation can reduce the risk of all\u00a0congenital malformations\u00a0(CMs) or the risk of a specific and selected group of them, namely cardiac defects and oral clefts. Furthermore, the effects on theprevention\u00a0of prematurity, foetal growth retardation and pre-eclampsia are unclear.Although the most common recommendation is to take 0.4\u00a0mg\/day, the problem of the most appropriate dose of FA is still open.The aim of this project is to assess the effect a higher dose of peri-conceptional FA supplementation on reducing the occurrence of all CMs.\u00a0Other\u00a0aims include the promotion of pre-conceptional counselling, comparing rates of selected CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age, abruptio placentae.<\/p>\n

METHODS\/DESIGN:<\/h4>\n
This project is a joint effort by research groups in\u00a0Italy\u00a0and\u00a0the Netherlands. Women of childbearing age, who intend to become pregnant within 12\u00a0months are eligible for the studies. Women are randomly assigned to receive 4\u00a0mg of FA (treatment in study) or 0.4\u00a0mg of FA (referent treatment) daily. Information onpregnancy outcomes\u00a0are derived from women-and-physician information.We foresee to analyze the data considering all the\u00a0adverse\u00a0outcomes\u00a0of\u00a0pregnancy\u00a0taken together in a global end point (e.g.: CMs, miscarriage, pre-eclampsia, preterm birth, small for gestational age). A total of about 1,000 pregnancies need to be evaluated to detect an absolute reduction of the frequency of 8%. Since the sample size needed for studying\u00a0outcomes\u00a0separately is large, this project also promotes an international prospective meta-analysis.<\/p>\n

DISCUSSION:<\/h4>\n
The rationale of these randomized clinical trials (RCTs) is the hypothesis that a higher intake of FA is related to a higher risk reduction of NTDs,\u00a0other\u00a0CMs and\u00a0other\u00a0adverse\u00a0pregnancy outcomes. Our hope is that these trials will act as catalysers, and lead to\u00a0other\u00a0large RCTs studying the effects of this supplementation on CMs andother\u00a0infant and maternal\u00a0outcomes.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"
Bortolus R1,\u00a0Blom F,\u00a0Filippini F,\u00a0van Poppel MN,\u00a0Leoncini E,\u00a0de Smit DJ,\u00a0Benetollo PP,\u00a0Cornel MC,\u00a0de Walle HE,\u00a0Mastroiacovo P;Italian and Dutch\u00a0folic acid\u00a0trial study groups. BACKGROUND: In 2010 a Cochrane review confirmed [\u2026]<\/span><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[],"class_list":["post-392","post","type-post","status-publish","format-standard","hentry","category-bibliografia-mthfr-prevent-plus"],"_links":{"self":[{"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/posts\/392","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/comments?post=392"}],"version-history":[{"count":1,"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/posts\/392\/revisions"}],"predecessor-version":[{"id":393,"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/posts\/392\/revisions\/393"}],"wp:attachment":[{"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/media?parent=392"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/categories?post=392"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pharmarte.com\/en\/wp-json\/wp\/v2\/tags?post=392"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}