Clinical trial NCT01248260: Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
Official title: Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Body Size
Fetal Brain Size
Keywords: Fetal body size
Fetal brain size
Folic acid
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 495
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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

Eligibility criteria: Inclusion Criteria:

((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 Criteria:

(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.

Primary outcomes:
measure: Fetal Body Size
timeFrame: Participants will be followed from baseline (first trimester) until delivery
measure: Fetal Brain Size
timeFrame: Participants will be followed from baseline (first trimester) until delivery
Secondary outcomes:
measure: Preterm Birth
timeFrame: Participants will be followed from baseline (first trimester) until delivery
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida, College of Public Health, Department of Epidemiology and Biostatistics
state: Florida
Study officials:
affiliation: University of South Florida
name: Hamisu M Salihu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yusuf KK, Salihu HM, Wilson R, Mbah A, Sappenfield W, Bruder K, Wudil UJ, Aliyu MH. Folic Acid Intake, Fetal Brain Growth, and Maternal Smoking in Pregnancy: A Randomized Controlled Trial. Curr Dev Nutr. 2019 Apr 4;3(6):nzz025. doi: 10.1093/cdn/nzz025. eCollection 2019 Jun.