Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098319
Status:
COMPLETED
Last Update Posted:
2013-12-17
First Post:
2004-12-06
Brief Title:
Oral Cleft Prevention Trial in Brazil
Sponsor:
NICHD Global Network for Womens and Childrens Health
Organization:
NICHD Global Network for Womens and Childrens Health
Study Overview
Official Title:
Oral Cleft Prevention Trial in Brazil
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 40 mg versus 04 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
Detailed Description:
Craniofacial anomalies and cleft lip with or without cleft palate CLP 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 4mgday at preconception and during the first three months of pregnancy will decrease the recurrence of nonsyndromic cleft lip with or without clef palate NSCLP in a high-risk group of women when compared to women taking 04 mg per day of folic acid The total sample will include 2000 women that either have NSCLP or that have at least one child with NSCLP randomly assigned to the 4 mg versus the 04 mg folic acid study groups The study will also compare the recurrence rates of NSCLP in the total sample of subjects as well as the two study groups 4mg 04 mg to that of a historical control group
The primary outcome assessed is the rate of recurrences of NSCLP in offspring of the trial mothers in each of the two study groups Secondary outcomes include recurrence of NSCLP compared to a historical control group serum and red cell folate levels severity of NSCLP 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 25 year period a dropout rate of 10 birth rate for group A women with NSCLP of 10 and a rate of 12 for group B women with at least one child with NSCLP risk of cleft for group A is 7 and for group B is 4 one-sided test with continuity correction
The primary outcome assessed is the rate of recurrences of NSCLP in offspring of the trial mothers in each of the two study groups Secondary outcomes include recurrence of NSCLP compared to a historical control group serum and red cell folate levels severity of NSCLP 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 25 year period a dropout rate of 10 birth rate for group A women with NSCLP of 10 and a rate of 12 for group B women with at least one child with NSCLP risk of cleft for group A is 7 and for group B is 4 one-sided test with continuity correction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None