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Related Experiment Video

Updated: May 16, 2026

Use of the Operant Orofacial Pain Assessment Device (OPAD) to Measure Changes in Nociceptive Behavior
12:20

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Published on: June 10, 2013

Oral cleft prevention program (OCPP).

George L Wehby1, Norman Goco, Danilo Moretti-Ferreira

  • 1University of Iowa, Iowa City, IA, USA.

BMC Pediatrics
|November 28, 2012
PubMed
Summary

This study investigates high versus low doses of folic acid (4 mg vs. 0.4 mg) to prevent oral cleft recurrence in at-risk women. Findings could inform clinical guidelines for cleft prevention.

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Area of Science:

  • Reproductive Health
  • Birth Defect Prevention
  • Clinical Trials

Background:

  • Oral clefts are common birth defects with complex causes, including genetic and environmental factors.
  • Folic acid supplementation shows promise in reducing cleft occurrence and recurrence, with higher doses potentially more effective.
  • Previous studies on folic acid for cleft prevention were limited by non-randomized designs.

Purpose of the Study:

  • To evaluate the effectiveness of high-dose (4 mg) versus low-dose (0.4 mg) folic acid in preventing nonsyndromic cleft lip with/without palate (NSCL/P) recurrence.
  • To compare recurrence rates between different folic acid dosages and a historical control group.
  • To provide evidence for optimizing folic acid dosage in clinical guidelines for at-risk pregnancies.

Main Methods:

  • A randomized clinical trial involving approximately 6,000 women at risk for NSCL/P.
  • Participants were randomly assigned to receive either 4 mg or 0.4 mg of folic acid daily, starting preconceptionally and continuing for 3 months into pregnancy.
  • Recurrence rates of NSCL/P were compared between the two folic acid groups and a historical control cohort.

Main Results:

  • The study is designed to assess the impact of different folic acid doses on NSCL/P recurrence.
  • Comparison with historical data will provide context for the observed recurrence rates.
  • Results will be disseminated through scientific publications and presentations.

Conclusions:

  • Preventing oral clefts can lead to significant cost savings and improved quality of life.
  • This research aims to establish evidence-based clinical guidelines for folic acid use in cleft prevention.
  • The findings will help tailor interventions for women at high risk of having a child with an oral cleft.