Smoking Reduction In Gravid Substance Use Disorders

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>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. | Diagnostic Test: knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels<br>* 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.<br>* Other names: adverse outcomes related to expired maternal carbon monoxide and fetal carboxyhemoglobin levels;|
| No Intervention: Control Group<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 10 months | 
| 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 | Through study completion, an average of 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant birthweight |  | Through study completion, an average of 10 months | 
| APGAR at 5 minutes |  | 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 |  | Through study completion, an average of 10 months | 
| Prevalence of smoking ≥10 cigarettes/day in each group at delivery, per patient report |  | Through study completion, an average of 10 months | 
| Average number of cigarettes smoked/day in each group, per patient report |  | At delivery | 
| Average exhaled carbon monoxide at final measurement |  | Through study completion, an average of 10 months | 
| Average percent fetal carboxyhemoglobin at final measurement |  | At delivery | 
| Small for gestational age at birth (<10th percentile) |  | 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) |  | 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 |  | Through study completion, an average of 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking in pregnancy, substance use disorder, carbon monoxide, fetal carboxyhemoglobin