Cleft Palate Clinical Trial
Official title:
Oral Cleft Prevention Trial in Brazil
Cleft lip and palate are a significant component of morbid human birth defects in the developing world. By supplementing a high-risk group of women with folic acid (4.0 mg versus 0.4 mg) from preconception and continuing throughout the first 3 months of pregnancy in the state of Sao Paulo, Brazil, this study aims to reduce the recurrence of cleft lip and palate.
Craniofacial anomalies and cleft lip with or without cleft palate (CL/P) are a model for the
impact of birth defects on fetal and neonatal health directly and maternal health
indirectly. Craniofacial anomalies comprise a significant component of morbid human birth
defects. The primary hypothesis is that folic acid supplementation of 4mg/day at
preconception and during the first three months of pregnancy will decrease the recurrence of
nonsyndromic cleft lip with or without clef palate (NSCL/P) in a high-risk group of women
when compared to women taking 0.4 mg per day of folic acid. The total sample will include
2,000 women (that either have NSCL/P or that have at least one child with NSCL/P) randomly
assigned to the 4 mg versus 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 (4mg, 0.4 mg) to that of a historical control group.
The primary outcome assessed is the rate of recurrences of NSCL/P in offspring of the trial
mothers in each of the two study groups. Secondary outcomes include recurrence of NSCL/P
compared to a historical control group; serum and red cell folate levels; severity of NSCL/P
in offspring of trial mothers; twinning rate; miscarriage rate; preeclampsia; rates of other
birth defects; birth weight; and gestational age. The sample size was based on historic
tables of birth rates and the rates of cleft occurrences. The study hypothesizes that a
total of 2000 subjects will be enrolled during a 2.5 year period; a dropout rate of 10%;
birth rate for group A (women with NSCL/P) of 10% and a rate of 12% for group B (women with
at least one child with NSCL/P); risk of cleft for group A is 7% and for group B is 4%;
one-sided test with continuity correction.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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