| Autor: |
Bortolus R; Office for Research Promotion, Verona University Hospital, 37134 Verona, Italy., Filippini F; Office for Research Promotion, Verona University Hospital, 37134 Verona, Italy., Cipriani S; Department of Woman, Newborn and Child, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy., Trevisanuto D; Department of Woman's and Child's Health, University of Padua, 35128 Padova, Italy., Cavallin F; Independent Statistician, 36020 Solagna, Italy., Zanconato G; Department of Surgery, Odontostomatology and Maternal and Child Health, University of Verona, 37134 Verona, Italy., Somigliana E; Department of Woman, Newborn and Child, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.; Department of Clinical Sciences and Community Health, University of Milan, 20122 Milan, Italy., Cesari E; Department of Obstetrics and Gynaecology, Sant'Antonio Abate Hospital, 21013 Gallarate, Italy., Mastroiacovo P; International Centre on Birth Defects-ICBD, 00195 Rome, Italy., Parazzini F; Department of Woman, Newborn and Child, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.; Department of Clinical Sciences and Community Health, University of Milan, 20122 Milan, Italy. |
| Abstrakt: |
Folic acid (FA) supplementation prevents neural tube defects (NTDs), but the effects on other reproductive outcomes are unclear. While common recommendation is 0.4 mg/day in addition to regular nutrition, the most appropriate dose of FA is still under debate. We investigated the effects of a higher dose of periconception FA on reducing adverse reproductive outcomes. In this multicenter double-blind randomized controlled trial (RCT), 1060 women (aged 18-44 years and planning a pregnancy) were randomly assigned to receive 4.0 mg or 0.4 mg of FA daily. The primary outcome was the occurrence of congenital malformations (CMs). A composite outcome including one or more adverse pregnancy outcomes was also evaluated. A total of 431 women had a natural conception within 1 year. The primary outcome occurred in 8/227 (3.5%) women receiving 4.0 mg FA and 9/204 (4.4%) women receiving 0.4 mg FA (RR 0.80; 95%CI 0.31 to 2.03). The composite outcome occurred in 43/227 (18.9%) women receiving 4.0 mg FA and 75/204 (36.8%) women receiving 0.4 mg FA (RR 0.51; 95%CI 0.40 to 0.68). FA 4.0 mg supplementation was not associated with different occurrence of CMs, compared to FA 0.4 mg supplementation. However, FA 4.0 mg supplementation was associated with lower occurrence of other adverse pregnancy outcomes. |
