Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial

Completed · Not applicable

Conditions studied: Fetal Body Size, Fetal Brain Size

In brief

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.

Key facts

Study ID

NCT01248260

Run by

Hamisu Salihu

People needed

495

Starts

2011-02-01

Expected to finish

2016-08-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• ((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.

You may not qualify if…

• (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.

Where it is running

• University of South Florida, College of Public Health, Department of Epidemiology and Biostatistics — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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