Smoking Reduction In Gravid Substance Use Disorders (SIGS)

December 19, 2022 updated by: Rubymel J Knupp, University of Alabama at Birmingham

Smoking Reduction In Gravid Women With Substance Use Disorders (SIGS): A Randomized Controlled Trial

The aim of this study is to encourage smoking cessation in women with substance use disorders by providing knowledge of expired carbon monoxide. We hypothesize that women who are provided knowledge of their expired carbon monoxide and the associated percent fetal carboxyhemoglobin will have a greater success at quitting smoking during pregnancy than women who are not provided this information.

A secondary aim of the study is to correlate expired carbon monoxide throughout pregnancy with infant birth weight.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial. Pregnant smokers who are substances users who meet inclusion criteria will be offered participation in the study at their first obstetrical appointment. Patients who consent to participate will be randomized.

At the enrollment/randomization visit, women will be randomized to either the intervention (knowledge of and interpretation carbon monoxide levels and associated percent fetal carboxyhemoglobin) or control group (no information on carbon monoxide and associated percent fetal carboxyhemoglobin). Allocation will be computer generated. This will be done after the patient meets all inclusion criteria. If randomization to the intervention arm, the patient will be notified of carbon monoxide and associated fetal carboxyhemoglobin levels at each obstetrical visit and counseled on how it affects maternal and fetal health.

If randomized to the control arm, the patient will have expired carbon monoxide and associated fetal carboxyhemoglobin levels measured at each obstetrical visit but blinded to these results. These patients will not be notified of the levels, nor counseled on what levels mean for maternal or fetal health.

See below for intervention and control protocols.

Maternal demographic (age, race, socioeconomic status), medical history (other medical problems, medications, height, weight) and obstetric history (parity, gestational age) data will be abstracted from the patient's chart and supplemented with a patient questionnaire at the enrollment/randomization visit. The primary outcome is the expired maternal carbon monoxide level at the last obstetric visit or at delivery. This will be determined by the Smokerlyzer device used to measure this. Secondary aims of the study will be to evaluate how maternal carbon monoxide levels correlate with fetal growth, cigarette use per day, patient satisfaction and neonatal birth weight.

All patients will have the following performed at the enrollment/randomization visit and subsequent prenatal visits:

a. The order of events for all patients will be as follows: i. Blood pressure evaluation ii. Weight iii. Fundal height iv. Patient will be asked the number of cigarettes used per day v. Patient will exhale into Smokerlyzer device to obtain expired carbon monoxide and associated percent fetal carboxyhemoglobin vi. Patients will be provided smoking cessation resources and counseling on smoking cessation in pregnancy

Intervention Protocol

  1. Intervention group will undergo Smokerlyzer ® exhaled carbon monoxide measurements at enrollment, each prenatal visit, and at their last (>36 week) prenatal visit or at delivery if not captured in clinic.
  2. Women will be informed of their exhaled carbon monoxide measurement at each visit as well as the correlation to fetal carboxyhemoglobin.
  3. At each visit, the intervention group will receive counseling on fetal impact of smoking based on fetal carboxyhemoglobin level and institutional and state information on smoking cessation will be provided.
  4. The patient will then proceed to the remainder of the obstetrical visit.

Control Protocol

  1. Women in the control group will undergo Smokerlyzer ® exhaled carbon monoxide measurements at enrollment, each prenatal visit and at their final (>36 week) prenatal visit or at delivery if not captured in clinic.
  2. Both levels (maternal carbon monoxide and fetal carboxyhemoglobin) will be recorded by the co-investigatory, but NOT disclosed to the patient
  3. At each visit, control group will be provided institutional and state information on smoking cessation if they report continued smoking.
  4. The patient will then proceed to remainder of the obstetrical visit.

For both groups:

At the time of delivery, maternal and neonatal outcome data will be recorded from the chart, including gestational age at delivery, mode of delivery, indications for delivery, birth weight, Apgar score, cord blood gas, length of stay, and neonatal complications, if any. A survey will be completed for both intervention and standard care groups after delivery.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University Of Alabama
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 43 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

i. Age 16-45

ii. Singleton gestation

iii. Gestational age at enrollment <24 weeks

iv. Substance use disorder defined as modified National Institute on Drug Abuse ASSIST ≥4

v. Cigarette smoker using ≥10 cigarettes/day interested in quitting

Exclusion criteria:

i. Known or suspected fetal growth restriction at enrollment

ii. Known fetal anomaly, aneuploidy, or demise

iii. Not interested in smoking cessation or reduction during pregnancy

iv. E-cigarette use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
  1. The patient will exhaled into the Smokerlyzer® device will at each visit
  2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient
  3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.
Diagnostic test: knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels
Will use the Smokerlyzer® device at each visit and be provided information on exhaled carbon monoxide and fetal carboxyhemoglobin. Risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin level will be provided.
Other Names:
  • adverse outcomes related to expired maternal carbon monoxide and fetal carboxyhemoglobin levels
No Intervention: Control Group
  1. The patient will exhale into the Smokerlyzer® device at each visit.
  2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient
  3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expired maternal carbon monoxide level
Time Frame: Through study completion, an average of 10 months
1. Prevalence of smoking ≥ 10 cigarettes/day in each group at final measurement by exhaled carbon monoxide level at last prenatal visit prior to delivery, as measured by exhaled carbon monoxide
Through study completion, an average of 10 months
Expired maternal carbon monoxide level at delivery
Time Frame: Through study completion, an average of 10 months
2. Prevalence of smoking ≥ 10 cigarettes/day in each group at final measurement by exhaled carbon monoxide level at delivery, as measured by exhaled carbon monoxide
Through study completion, an average of 10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Infant birthweight
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months
APGAR at 5 minutes
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months
Average number of cigarettes smoked/day in each group, as measured by exhaled carbon monoxide at final measurement
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months
Prevalence of smoking ≥10 cigarettes/day in each group at delivery, per patient report
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months
Average number of cigarettes smoked/day in each group, per patient report
Time Frame: At delivery
At delivery
Average exhaled carbon monoxide at final measurement
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months
Average percent fetal carboxyhemoglobin at final measurement
Time Frame: At delivery
At delivery
Small for gestational age at birth (<10th percentile)
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months
Infant birth weight as a function of carboxyhemoglobin in pregnancy (first and last measured; average of all measurements in intervention group)
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months
Patient satisfaction at final prenatal visit, measured by PANAS scales (positive and negative affect scales) and select questions at last visit or delivery on Stop Smoking Service Client Satisfaction Survey
Time Frame: Through study completion, an average of 10 months
Through study completion, an average of 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Rachel G Sinkey, MD, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

October 12, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 18, 2019

Study Record Updates

Last Update Posted (Estimate)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIGS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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