Journal article
Periconceptional use of folic acid and risk of miscarriage – findings of the Oral Cleft Prevention Program in Brazil
Journal of perinatal medicine, Vol.41(4), pp.461-466
07/01/2013
DOI: 10.1515/jpm-2012-0173
PMCID: PMC3784004
PMID: 23669628
Abstract
We report on the risk of miscarriage with high- and low-dosage periconceptional folic acid (FA) supplementation from a double-blind randomized clinical trial for prevention of orofacial cleft recurrence in Brazil.
Women at risk of recurrence of orofacial clefts in their offspring were randomized into high (4 mg/day) and low (0.4 mg/day) doses of FA supplementation. The women received the study pills before pregnancy, and supplementation continued throughout the first trimester. Miscarriage rates were compared between the two FA groups and with the population rate.
A total of 268 pregnancies completed the study protocol, with 141 in the 4.0-mg group and 127 in the 0.4-mg group. The miscarriage rate was 14.2% in the low-dose FA group (0.4 mg/day) and 11.3% for the high-dose group (4 mg/day) (P=0.4877). These miscarriage rates are not significantly different from the miscarriage rate in the Brazilian population, estimated to be around 14% (P=0.311).
These results indicate that high-dose FA does not increase miscarriage risk in this population and add further information to the literature on the safety of high FA supplementation for prevention of birth defect recurrence.
Details
- Title: Subtitle
- Periconceptional use of folic acid and risk of miscarriage – findings of the Oral Cleft Prevention Program in Brazil
- Creators
- Camila Vila-NovaGeorge L Wehby - Department of Health Management and Policy, College of Public Health, University of Iowa, Iowa City, IA, USAFernanda C Queirós - Department of Maternal and Child Health, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USAHrishkesh Chakraborty - Department of Epidemiology and Biostatistics, Arnold School of Global Public Health, University of South Carolina, Columbia, SC, USATemis M Félix - Medical Genetics Service, Hospital de Clinicas de Porto Alegre, Porto Alegre, RS, BrazilNorman Goco - Statistics and Epidemiology, RTI International, Research Triangle Park, NC, USAJanet Moore - Statistics and Epidemiology, RTI International, Research Triangle Park, NC, USAEduardo V Gewehr - Obras Sociais Irmã Dulce (Santo Antônio Hospital), Salvador, BA, BrazilLorene Lins - Obras Sociais Irmã Dulce (Santo Antônio Hospital), Salvador, BA, BrazilCarla M.C Affonso - Center of Rehabilitation of Craniofacial Anomalies (Centrinho), Obras Sociais Irmã Dulce (Santo Antônio Hospital), Salvador, BA, BrazilJeffrey C Murray - Department of Pediatrics, Division of Neonatology, University of Iowa, Iowa City, IA, USA
- Resource Type
- Journal article
- Publication Details
- Journal of perinatal medicine, Vol.41(4), pp.461-466
- DOI
- 10.1515/jpm-2012-0173
- PMID
- 23669628
- PMCID
- PMC3784004
- NLM abbreviation
- J Perinat Med
- ISSN
- 0300-5577
- eISSN
- 1619-3997
- Publisher
- De Gruyter
- Language
- English
- Date published
- 07/01/2013
- Academic Unit
- Preventive and Community Dentistry; Anatomy and Cell Biology; Health Management and Policy; Stead Family Department of Pediatrics; Epidemiology; Economics; Pediatric Dentistry; Craniofacial Anomalies Research Center; Public Policy Center (Archive); Dental Research
- Record Identifier
- 9984025477902771
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