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Knowledge of Biomarker Levels for Smoking Reduction in Pregnant Substance Use Disorders (SIGS Trial)

N/A
Recruiting
Led By Rachel G Sinkey, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 10 months
Awards & highlights

SIGS Trial Summary

This trial will test if informing pregnant women of their expired carbon monoxide levels will help them quit smoking. Additionally, they will study if there is a correlation between carbon monoxide levels and birth weight.

Eligible Conditions
  • Tobacco Smoking
  • Tobacco Use Disorder
  • Tobacco Use in Pregnancy

SIGS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Expired maternal carbon monoxide level
Expired maternal carbon monoxide level at delivery
Secondary outcome measures
APGAR at 5 minutes
Average exhaled carbon monoxide at final measurement
Average number of cigarettes smoked/day in each group, as measured by exhaled carbon monoxide at final measurement
+7 more

SIGS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment GroupExperimental Treatment1 Intervention
The patient will exhaled into the Smokerlyzer® device will at each visit Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.
Group II: Control GroupActive Control1 Intervention
The patient will exhale into the Smokerlyzer® device at each visit. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,279,970 Total Patients Enrolled
Rachel G Sinkey, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
Lorie M Harper, MDPrincipal InvestigatorUniversity of Texas - Dell
1 Previous Clinical Trials
53 Total Patients Enrolled

Media Library

Knowledge of Expired Maternal Carbon Monoxide and Fetal Carboxyhemoglobin Levels Clinical Trial Eligibility Overview. Trial Name: NCT04132232 — N/A
Tobacco Smoking Clinical Trial 2023: Knowledge of Expired Maternal Carbon Monoxide and Fetal Carboxyhemoglobin Levels Highlights & Side Effects. Trial Name: NCT04132232 — N/A
Tobacco Smoking Research Study Groups: Treatment Group, Control Group
Knowledge of Expired Maternal Carbon Monoxide and Fetal Carboxyhemoglobin Levels 2023 Treatment Timeline for Medical Study. Trial Name: NCT04132232 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Mississippi
How old are they?
18 - 65
What site did they apply to?
University of Alabama
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. University of Alabama: < 48 hours
Typically responds via
Phone Call
Recent research and studies
European Journal of Obstetrics & Gynecology and Reproductive BiologyJournal
The Implications of High Carbon Monoxide Levels in Early Pregnancy for Neonatal Outcomes
Reynolds, Ciara M.E., Brendan Egan, Rachel A. Kennedy, Eimer O’Malley, Sharon R. Sheehan, and Michael J. Turner. 2019. “The Implications of High Carbon Monoxide Levels in Early Pregnancy for Neonatal Outcomes”. European Journal of Obstetrics & Gynecology and Reproductive Biology. Elsevier BV. doi:10.1016/j.ejogrb.2018.11.020.
PLoS ONEJournal
Assessing Recent Smoking Status by Measuring Exhaled Carbon Monoxide Levels
Sandberg, AnnSofi, C. Magnus Sköld, Johan Grunewald, Anders Eklund, and Åsa M. Wheelock. 2011. “Assessing Recent Smoking Status by Measuring Exhaled Carbon Monoxide Levels”. Edited by Mauricio Rojas. Plos ONE. Public Library of Science (PLoS). doi:10.1371/journal.pone.0028864.
Preventive MedicineJournal
Expired Air Carbon Monoxide Concentration in Mothers and Their Spouses Above 5 Ppm Is Associated with Decreased Fetal Growth
Gomez, Conchita, Ivan Berlin, Pierre Marquis, and Michel Delcroix. 2005. “Expired Air Carbon Monoxide Concentration in Mothers and Their Spouses Above 5 Ppm Is Associated with Decreased Fetal Growth”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2004.04.049.
ChestJournal
Use of Expired Air Carbon Monoxide Testing in Clinical Tobacco Treatment Settings
Goldstein, Adam O., Stephanie P. Gans, Carol Ripley-Moffitt, Chris Kotsen, and Matthew Bars. 2018. “Use of Expired Air Carbon Monoxide Testing in Clinical Tobacco Treatment Settings”. Chest. Elsevier BV. doi:10.1016/j.chest.2017.11.002.
All > Smoking
~18 spots leftby Apr 2025
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