Skip to main content
Journal cover image

Oral cleft prevention program (OCPP).

Publication ,  Journal Article
Wehby, GL; Goco, N; Moretti-Ferreira, D; Felix, T; Richieri-Costa, A; Padovani, C; Queiros, F; Guimaraes, CVN; Pereira, R; Litavecz, S ...
Published in: BMC Pediatr
November 26, 2012

BACKGROUND: Oral clefts are one of the most common birth defects with significant medical, psychosocial, and economic ramifications. Oral clefts have a complex etiology with genetic and environmental risk factors. There are suggestive results for decreased risks of cleft occurrence and recurrence with folic acid supplements taken at preconception and during pregnancy with a stronger evidence for higher than lower doses in preventing recurrence. Yet previous studies have suffered from considerable design limitations particularly non-randomization into treatment. There is also well-documented effectiveness for folic acid in preventing neural tube defect occurrence at 0.4 mg and recurrence with 4 mg. Given the substantial burden of clefting on the individual and the family and the supportive data for the effectiveness of folic acid supplementation as well as its low cost, a randomized clinical trial of the effectiveness of high versus low dose folic acid for prevention of cleft recurrence is warranted. METHODS/DESIGN: This study will assess the effect of 4 mg and 0.4 mg doses of folic acid, taken on a daily basis during preconception and up to 3 months of pregnancy by women who are at risk of having a child with nonsyndromic cleft lip with/without palate (NSCL/P), on the recurrence of NSCL/P. The total sample will include about 6,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly assigned to the 4 mg and the 0.4 mg folic acid study groups. The study will also compare the recurrence rates of NSCL/P in the total sample of subjects, as well as the two study groups (4 mg, 0.4 mg) to that of a historical control group. The study has been approved by IRBs (ethics committees) of all involved sites. Results will be disseminated through publications and presentations at scientific meetings. DISCUSSION: The costs related to oral clefts are high, including long term psychological and socio-economic effects. This study provides an opportunity for huge savings in not only money but the overall quality of life. This may help establish more specific clinical guidelines for oral cleft prevention so that the intervention can be better tailored for at-risk women. CLINICALTRIALS.GOV IDENTIFIER: NCT00397917.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

BMC Pediatr

DOI

EISSN

1471-2431

Publication Date

November 26, 2012

Volume

12

Start / End Page

184

Location

England

Related Subject Headings

  • Vitamin B Complex
  • Secondary Prevention
  • Research Design
  • Prenatal Care
  • Pregnancy
  • Preconception Care
  • Pilot Projects
  • Pediatrics
  • Infant, Newborn
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Wehby, G. L., Goco, N., Moretti-Ferreira, D., Felix, T., Richieri-Costa, A., Padovani, C., … Murray, J. C. (2012). Oral cleft prevention program (OCPP). BMC Pediatr, 12, 184. https://doi.org/10.1186/1471-2431-12-184
Wehby, George L., Norman Goco, Danilo Moretti-Ferreira, Temis Felix, Antonio Richieri-Costa, Carla Padovani, Fernanda Queiros, et al. “Oral cleft prevention program (OCPP).BMC Pediatr 12 (November 26, 2012): 184. https://doi.org/10.1186/1471-2431-12-184.
Wehby GL, Goco N, Moretti-Ferreira D, Felix T, Richieri-Costa A, Padovani C, et al. Oral cleft prevention program (OCPP). BMC Pediatr. 2012 Nov 26;12:184.
Wehby, George L., et al. “Oral cleft prevention program (OCPP).BMC Pediatr, vol. 12, Nov. 2012, p. 184. Pubmed, doi:10.1186/1471-2431-12-184.
Wehby GL, Goco N, Moretti-Ferreira D, Felix T, Richieri-Costa A, Padovani C, Queiros F, Guimaraes CVN, Pereira R, Litavecz S, Hartwell T, Chakraborty H, Javois L, Murray JC. Oral cleft prevention program (OCPP). BMC Pediatr. 2012 Nov 26;12:184.
Journal cover image

Published In

BMC Pediatr

DOI

EISSN

1471-2431

Publication Date

November 26, 2012

Volume

12

Start / End Page

184

Location

England

Related Subject Headings

  • Vitamin B Complex
  • Secondary Prevention
  • Research Design
  • Prenatal Care
  • Pregnancy
  • Preconception Care
  • Pilot Projects
  • Pediatrics
  • Infant, Newborn
  • Humans