Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
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|ClinicalTrials.gov Identifier: NCT01248260|
Recruitment Status : Unknown
Verified December 2015 by Hamisu Salihu, University of South Florida.
Recruitment status was: Active, not recruiting
First Posted : November 25, 2010
Last Update Posted : December 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Fetal Body Size Fetal Brain Size||Dietary Supplement: Folic Acid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2016|
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)
- Fetal Body Size [ Time Frame: Participants will be followed from baseline (first trimester) until delivery ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248260
|United States, Florida|
|University of South Florida, College of Public Health, Department of Epidemiology and Biostatistics|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Hamisu M Salihu, MD, PhD||University of South Florida|