Status:
COMPLETED
Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
Lead Sponsor:
Hamisu Salihu
Conditions:
Fetal Body Size
Fetal Brain Size
Eligibility:
FEMALE
18-44 years
Phase:
NA
Brief Summary
The purpose of this study is to find out if folic acid prevents of the reduction of fetal body and brain size in infants whose mothers smoke.
Detailed Description
Smoking during pregnancy remains a common practice despite smoking cessation programs offered to mothers. Only 20-40% of women quit smoking during pregnancy which implies that a majority of smokers co...
Eligibility Criteria
Inclusion
- ((1) Smoker, based on presence of detectable cotinine in saliva (biomarker).; (2) Ages 18-44 years; (3) Singleton gestation (\< 20 weeks), confirmed by sonogram; (4) Residents of Tampa, Florida or surrounding area in order to facilitate follow-up and reduce attrition rate.
Exclusion
- (a) an indication for chronic blood transfusion. Women receiving chronic blood transfusions will not be enrolled, as transfused red blood cells (RBC) can result in inaccurate analysis of folate RBC levels88; (b) generalized seizure disorder treated with anti-convulsant medication: Patients with generalized seizure disorder treated with anticonvulsant medication will be excluded because of the potential association with folic acid deficiency88.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT01248260
Start Date
February 1 2011
End Date
August 1 2016
Last Update
February 15 2019
Active Locations (1)
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1
University of South Florida, College of Public Health, Department of Epidemiology and Biostatistics
Tampa, Florida, United States, 33612