Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial|
- Fetal Body Size [ Time Frame: Participants will be followed from baseline (first trimester) until delivery ] [ Designated as safety issue: No ]Low birth weight will be defined as birth weight less than 2500g; Small for gestational age will be defined as birth weight in the lowest 10th percentile; The fetal growth ratio will be expressed as the ratio of the observed birth weight to the expected mean birth weight for each gestational age.
- Fetal Brain Size [ Time Frame: Participants will be followed from baseline (first trimester) until delivery ] [ Designated as safety issue: No ]Head Circumference at birth: will be measured at birth as routinely performed at the study site. Observed: Expected head circumference ratio: This is the ratio between the actual head circumference and the expected head circumference according to gestational age (this could also be expressed in terms of percentage of expected head circumference). Brain weight: will be estimated from formula: brain weight (g) = 0.037 X head circumference (cm)2.57. Brain-to-body ratio (BBR): The BBR is defined as 100 the ratio of the infant's estimated brain weight to its birth weight.
- Preterm Birth [ Time Frame: Participants will be followed from baseline (first trimester) until delivery ] [ Designated as safety issue: No ]This is defined as live birth after 20 weeks of gestation but before 37 completed weeks. Genetic and Epigenetic Markers of Fetal Brain Growth and Development: Cord blood obtained at delivery will be analyzed for selected regulatory genes.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Higher-strength folic acid
Higher-strength folic acid (4mg).
Dietary Supplement: Folic Acid
4mg of higher strength folic acid once a day until delivery
No Intervention: Low-strength folic acid
Low-strength (0.8mg) folic acid (standard of care)
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 continue smoking despite the associated feto-infant morbidity and mortality. It is therefore important to identify ways and means of protecting these infants as they grow and develop during intrauterine life. In this study, we propose to assess the utility of higher-strength folic acid (4mg) combined with smoking cessation programs as compared to standard of care (smoking cessation program and low-strength (0.8mg) folic acid) in reducing the level of morbidity (specifically fetal body and brain size) sustained by infants of smokers
|Contact: Hamisu M Salihu, MD, PhDfirstname.lastname@example.org|
|Contact: Lindsey M King, MPH||813-974-3730||LKing1@health.usf.edu|
|United States, Florida|
|University of South Florida, College of Public Health, Department of Epidemiology and Biostatistics||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Hamisu M Salihu, MD, PhD 205-910-8720 email@example.com|
|Contact: Lindsey M King, MPH, CHES 813-974-3730 LKing1@health.usf.edu|
|Principal Investigator:||Hamisu M Salihu, MD, PhD||University of South Florida|