Trial reportJournal of perinatal medicine2013
Periconceptional use of folic acid and risk of miscarriage - findings of the Oral Cleft Prevention Program in Brazil.
Trial report in Journal of perinatal medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00397917 (Oral Cleft Prevention Program), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Oral Cleft Prevention Program
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.
- Vitamin supplementation for preventing miscarriage.The Cochrane database of systematic reviews · 2016Pooled it
- Effects and safety of periconceptional oral folate supplementation for preventing birth defects.The Cochrane database of systematic reviews · 2015Pooled it
- Efficacy of 4.0 mg versus 0.4 mg Folic Acid Supplementation on the Reproductive Outcomes: A Randomized Controlled Trial.Nutrients · 2021Trial
- Randomized controlled trial of 4.0 mg versus 0.4 mg folic acid supplementation: Follow-up of children at 1 year of age.European journal of obstetrics & gynecology and reproductive biology: X · 2025Article
- Effects of preconception care and periconception interventions on maternal nutritional status and birth outcomes in low- and middle-income countries: A systematic review.Campbell systematic reviews · 2021Review
- Article
- Awareness and Use of Folic Acid among Women of Childbearing Age.Annals of global health · 2019Article
- Diet and fertility: a review.American journal of obstetrics and gynecology · 2018Review
- Prepregnancy Nutrition and Early Pregnancy Outcomes.Current nutrition reports · 2015Article
- Folic acid supplementation in pregnancy and implications in health and disease.Journal of biomedical science · 2014Review
- Maternal prepregnancy folate intake and risk of spontaneous abortion and stillbirth.Obstetrics and gynecology · 2014Article
- The impact of folic acid supplementation on gestational and long term health: Critical temporal windows, benefits and risks.Porto biomedical journalReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 2 countries.
Funding
Abstract
objectiveWe 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.
methodsWomen 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.
resultsA 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).
conclusionsThese 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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.