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Smoking Reduction In Gravid Substance Use Disorders (SIGS)

Primary Purpose

Tobacco Smoking in Mother Complicating Pregnancy, Tobacco Use Disorder, Tobacco Smoking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Smoking in Mother Complicating Pregnancy focused on measuring smoking in pregnancy, substance use disorder, carbon monoxide, fetal carboxyhemoglobin

Eligibility Criteria

16 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of AlabamaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Expired maternal carbon monoxide level
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
Expired maternal carbon monoxide level at delivery
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

Secondary Outcome Measures

Infant birthweight
APGAR at 5 minutes
Average number of cigarettes smoked/day in each group, as measured by exhaled carbon monoxide at final measurement
Prevalence of smoking ≥10 cigarettes/day in each group at delivery, per patient report
Average number of cigarettes smoked/day in each group, per patient report
Average exhaled carbon monoxide at final measurement
Average percent fetal carboxyhemoglobin at final measurement
Small for gestational age at birth (<10th percentile)
Infant birth weight as a function of carboxyhemoglobin in pregnancy (first and last measured; average of all measurements in intervention group)
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

Full Information

First Posted
October 12, 2019
Last Updated
December 19, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04132232
Brief Title
Smoking Reduction In Gravid Substance Use Disorders
Acronym
SIGS
Official Title
Smoking Reduction In Gravid Women With Substance Use Disorders (SIGS): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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 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. Women will be informed of their exhaled carbon monoxide measurement at each visit as well as the correlation to fetal carboxyhemoglobin. 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. The patient will then proceed to the remainder of the obstetrical visit. Control Protocol 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. Both levels (maternal carbon monoxide and fetal carboxyhemoglobin) will be recorded by the co-investigatory, but NOT disclosed to the patient At each visit, control group will be provided institutional and state information on smoking cessation if they report continued smoking. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Smoking in Mother Complicating Pregnancy, Tobacco Use Disorder, Tobacco Smoking
Keywords
smoking in pregnancy, substance use disorder, carbon monoxide, fetal carboxyhemoglobin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Participant
Masking Description
Will not discuss percent fetal carboxyhemoglobin to control group versus disclosing percent fetal carboxyhemoglobin to intervention group.
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels
Other Intervention Name(s)
adverse outcomes related to expired maternal carbon monoxide and fetal carboxyhemoglobin levels
Intervention Description
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.
Primary Outcome Measure Information:
Title
Expired maternal carbon monoxide level
Description
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
Time Frame
Through study completion, an average of 10 months
Title
Expired maternal carbon monoxide level at delivery
Description
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
Time Frame
Through study completion, an average of 10 months
Secondary Outcome Measure Information:
Title
Infant birthweight
Time Frame
Through study completion, an average of 10 months
Title
APGAR at 5 minutes
Time Frame
Through study completion, an average of 10 months
Title
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
Title
Prevalence of smoking ≥10 cigarettes/day in each group at delivery, per patient report
Time Frame
Through study completion, an average of 10 months
Title
Average number of cigarettes smoked/day in each group, per patient report
Time Frame
At delivery
Title
Average exhaled carbon monoxide at final measurement
Time Frame
Through study completion, an average of 10 months
Title
Average percent fetal carboxyhemoglobin at final measurement
Time Frame
At delivery
Title
Small for gestational age at birth (<10th percentile)
Time Frame
Through study completion, an average of 10 months
Title
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
Title
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women and neonates: male and females
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Dimperio
Phone
205-934-3276
Email
ldimperio@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel G Sinkey, MD
Phone
205-934-5611
Email
rsinkey@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel G Sinkey, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rubymel Knupp, MD
Phone
205-934-2565
Email
rknupp@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Rachel G Sinkey, MD
Email
rsinkey@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22194931
Citation
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Results Reference
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Results Reference
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PubMed Identifier
15530575
Citation
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Citation
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Results Reference
background
Links:
URL
https://www.covita.net/product/microbaby-smokerlyzer/
Description
Smokerlyzer product website

Learn more about this trial

Smoking Reduction In Gravid Substance Use Disorders

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