Overview

This trial is active, not recruiting.

Conditions fetal body size, fetal brain size
Treatment folic acid
Sponsor Hamisu Salihu
Start date February 2011
End date August 2016
Trial size 450 participants
Trial identifier NCT01248260, 1KG14

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Higher-strength folic acid (4mg).
folic acid
4mg of higher strength folic acid once a day until delivery
(No Intervention)
Low-strength (0.8mg) folic acid (standard of care)

Primary Outcomes

Measure
Fetal Body Size
time frame: Participants will be followed from baseline (first trimester) until delivery
Fetal Brain Size
time frame: Participants will be followed from baseline (first trimester) until delivery

Secondary Outcomes

Measure
Preterm Birth
time frame: Participants will be followed from baseline (first trimester) until delivery

Eligibility Criteria

Female participants from 18 years up to 44 years old.

Inclusion Criteria

    Exclusion Criteria

      Additional Information

      Official title Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
      Principal investigator Hamisu M Salihu, MD, PhD
      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
      Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
      Information provided to ClinicalTrials.gov by University of South Florida.