Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-01 @ 6:38 PM
Study NCT ID:
NCT04132232
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2019-10-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Smoking Reduction In Gravid Substance Use Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064424', 'term': 'Tobacco Use'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctblanchard@uabmc.edu', 'phone': '205-934-7982', 'title': 'Christina Blanchard', 'organization': 'UAB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Over the course of the study period, which is around 10 months per participant.', 'description': 'As this is a low-risk study, an independent data safety monitoring board will not be formed.\n\nWe defined an adverse event as an undesirable experience or outcome occurring in a research participant, regardless of whether participation in the research study caused the event to occur. For example, placental abruption and/or stillbirth are known risks of pregnancy, and while not associated with the Smokerlyzer® device, would be considered an adverse event if it occurred during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group', 'description': '1. The patient will exhaled into the Smokerlyzer® device will at each visit\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient\n3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.\n\nknowledge 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.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': '1. The patient will exhale into the Smokerlyzer® device at each visit.\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient\n3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 0, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of Smoking ≥ 10 Cigarettes/Day in Each Group at Final Measurement by Exhaled Carbon Monoxide Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group', 'description': '1. The patient will exhaled into the Smokerlyzer® device will at each visit\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient\n3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.\n\nknowledge 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.'}, {'id': 'OG001', 'title': 'Control Group', 'description': '1. The patient will exhale into the Smokerlyzer® device at each visit.\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient\n3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Final measurement (last prenatal care visit or at delivery)', 'description': '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', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had expired carbon monoxide measured at either their last prenatal visit or at delivery.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group', 'description': '1. The patient will exhaled into the Smokerlyzer® device will at each visit\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient\n3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.\n\nknowledge 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.'}, {'id': 'FG001', 'title': 'Control Group', 'description': '1. The patient will exhale into the Smokerlyzer® device at each visit.\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient\n3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Randomized but met exclusion criteria.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group', 'description': '1. The patient will exhaled into the Smokerlyzer® device will at each visit\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient\n3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.\n\nknowledge 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.'}, {'id': 'BG001', 'title': 'Control Group', 'description': '1. The patient will exhale into the Smokerlyzer® device at each visit.\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient\n3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.3', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '32.4', 'spread': '9.4', 'groupId': 'BG001'}, {'value': '31.3', 'spread': '8.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Expired Maternal Carbon Monoxide Level at randomization', 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '11.2', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '7.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ppm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Average number of cigarettes per day at enrollment', 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '12.6', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '12.4', 'spread': '4.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cigarettes', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-14', 'size': 1912675, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2024-01-05T09:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Will not discuss percent fetal carboxyhemoglobin to control group versus disclosing percent fetal carboxyhemoglobin to intervention group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-28', 'studyFirstSubmitDate': '2019-10-12', 'resultsFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-28', 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Smoking ≥ 10 Cigarettes/Day in Each Group at Final Measurement by Exhaled Carbon Monoxide Level', 'timeFrame': 'Final measurement (last prenatal care visit or at delivery)', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['smoking in pregnancy', 'substance use disorder', 'carbon monoxide', 'fetal carboxyhemoglobin'], 'conditions': ['Tobacco Smoking in Mother Complicating Pregnancy', 'Tobacco Use Disorder', 'Tobacco Smoking']}, 'referencesModule': {'references': [{'pmid': '22194931', 'type': 'BACKGROUND', 'citation': 'Sandberg A, Skold CM, Grunewald J, Eklund A, Wheelock AM. Assessing recent smoking status by measuring exhaled carbon monoxide levels. PLoS One. 2011;6(12):e28864. doi: 10.1371/journal.pone.0028864. Epub 2011 Dec 16.'}, {'type': 'BACKGROUND', 'citation': 'Bedfont. Smokerlyzer range user manual. http://www.bedfont.com/file.php?f=ZmlsZSMjMTgxMg. Updated 2019. Accessed Sept 16, 2016.'}, {'pmid': '15530575', 'type': 'BACKGROUND', 'citation': 'Gomez C, Berlin I, Marquis P, Delcroix M. Expired air carbon monoxide concentration in mothers and their spouses above 5 ppm is associated with decreased fetal growth. Prev Med. 2005 Jan;40(1):10-5. doi: 10.1016/j.ypmed.2004.04.049.'}, {'pmid': '29137909', 'type': 'BACKGROUND', 'citation': 'Goldstein AO, Gans SP, Ripley-Moffitt C, Kotsen C, Bars M. Use of Expired Air Carbon Monoxide Testing in Clinical Tobacco Treatment Settings. Chest. 2018 Feb;153(2):554-562. doi: 10.1016/j.chest.2017.11.002. Epub 2017 Nov 11.'}, {'pmid': '26997495', 'type': 'BACKGROUND', 'citation': 'Riaz M, Lewis S, Coleman T, Aveyard P, West R, Naughton F, Ussher M. Which measures of cigarette dependence are predictors of smoking cessation during pregnancy? Analysis of data from a randomized controlled trial. Addiction. 2016 Sep;111(9):1656-65. doi: 10.1111/add.13395. Epub 2016 May 6.'}, {'pmid': '23343063', 'type': 'BACKGROUND', 'citation': 'Jha P, Ramasundarahettige C, Landsman V, Rostron B, Thun M, Anderson RN, McAfee T, Peto R. 21st-century hazards of smoking and benefits of cessation in the United States. N Engl J Med. 2013 Jan 24;368(4):341-50. doi: 10.1056/NEJMsa1211128.'}, {'pmid': '28426642', 'type': 'BACKGROUND', 'citation': 'QuickStats: Number of Deaths from 10 Leading Causes,* by Sex - National Vital Statistics System, United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Apr 21;66(15):413. doi: 10.15585/mmwr.mm6615a8.'}, {'pmid': '10713003', 'type': 'BACKGROUND', 'citation': 'Middleton ET, Morice AH. Breath carbon monoxide as an indication of smoking habit. Chest. 2000 Mar;117(3):758-63. doi: 10.1378/chest.117.3.758.'}, {'pmid': '11575171', 'type': 'BACKGROUND', 'citation': 'McClure JB. Are biomarkers a useful aid in smoking cessation? A review and analysis of the literature. Behav Med. 2001 Spring;27(1):37-47. doi: 10.1080/08964280109595770.'}, {'type': 'BACKGROUND', 'citation': '11. Bedfont. Smokerlyzer range user manual. http://www.bedfont.com/file.php?f=ZmlsZSMjMTgxMg. Updated 2019. Accessed Sept 16, 2019.'}, {'pmid': '21299294', 'type': 'BACKGROUND', 'citation': 'Shahab L, West R, McNeill A. A randomized, controlled trial of adding expired carbon monoxide feedback to brief stop smoking advice: evaluation of cognitive and behavioral effects. Health Psychol. 2011 Jan;30(1):49-57. doi: 10.1037/a0021821.'}, {'pmid': '23235615', 'type': 'BACKGROUND', 'citation': 'Bize R, Burnand B, Mueller Y, Rege-Walther M, Camain JY, Cornuz J. Biomedical risk assessment as an aid for smoking cessation. Cochrane Database Syst Rev. 2012 Dec 12;12:CD004705. doi: 10.1002/14651858.CD004705.pub4.'}, {'pmid': '30529257', 'type': 'BACKGROUND', 'citation': "Reynolds CME, Egan B, Kennedy RA, O'Malley E, Sheehan SR, Turner MJ. The implications of high carbon monoxide levels in early pregnancy for neonatal outcomes. Eur J Obstet Gynecol Reprod Biol. 2019 Feb;233:6-11. doi: 10.1016/j.ejogrb.2018.11.020. Epub 2018 Nov 30."}, {'pmid': '30928567', 'type': 'BACKGROUND', 'citation': 'Ecker J, Abuhamad A, Hill W, Bailit J, Bateman BT, Berghella V, Blake-Lamb T, Guille C, Landau R, Minkoff H, Prabhu M, Rosenthal E, Terplan M, Wright TE, Yonkers KA. Substance use disorders in pregnancy: clinical, ethical, and research imperatives of the opioid epidemic: a report of a joint workshop of the Society for Maternal-Fetal Medicine, American College of Obstetricians and Gynecologists, and American Society of Addiction Medicine. Am J Obstet Gynecol. 2019 Jul;221(1):B5-B28. doi: 10.1016/j.ajog.2019.03.022. Epub 2019 Mar 27. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://www.covita.net/product/microbaby-smokerlyzer/', 'label': 'Smokerlyzer product website'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA secondary aim of the study is to correlate expired carbon monoxide throughout pregnancy with infant birth weight.', 'detailedDescription': "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.\n\nAt 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.\n\nIf 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.\n\nSee below for intervention and control protocols.\n\nMaternal 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.\n\nAll patients will have the following performed at the enrollment/randomization visit and subsequent prenatal visits:\n\na. 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\n\nIntervention Protocol\n\n1. 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.\n2. Women will be informed of their exhaled carbon monoxide measurement at each visit as well as the correlation to fetal carboxyhemoglobin.\n3. 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.\n4. The patient will then proceed to the remainder of the obstetrical visit.\n\nControl Protocol\n\n1. 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.\n2. Both levels (maternal carbon monoxide and fetal carboxyhemoglobin) will be recorded by the co-investigatory, but NOT disclosed to the patient\n3. At each visit, control group will be provided institutional and state information on smoking cessation if they report continued smoking.\n4. The patient will then proceed to remainder of the obstetrical visit.\n\nFor both groups:\n\nAt 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '16 Years', 'genderBased': True, 'genderDescription': 'Pregnant women and neonates: male and females', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\ni. Age 16-45\n\nii. Singleton gestation\n\niii. Gestational age at enrollment \\<24 weeks\n\niv. Substance use disorder defined as modified National Institute on Drug Abuse ASSIST ≥4\n\nv. Cigarette smoker using ≥10 cigarettes/day interested in quitting\n\nExclusion criteria:\n\ni. Known or suspected fetal growth restriction at enrollment\n\nii. Known fetal anomaly, aneuploidy, or demise\n\niii. Not interested in smoking cessation or reduction during pregnancy\n\niv. E-cigarette use'}, 'identificationModule': {'nctId': 'NCT04132232', 'acronym': 'SIGS', 'briefTitle': 'Smoking Reduction In Gravid Substance Use Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Smoking Reduction In Gravid Women With Substance Use Disorders (SIGS): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SIGS'}, 'secondaryIdInfos': [{'id': 'JCHF', 'type': 'OTHER_GRANT', 'domain': 'Jefferson County Health Fund'}, {'id': 'UAB', 'type': 'OTHER_GRANT', 'domain': 'University of Alabama Ob/Gyn Fund for Excellence in Education'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': '1. The patient will exhaled into the Smokerlyzer® device will at each visit\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient\n3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.', 'interventionNames': ['Diagnostic Test: knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '1. The patient will exhale into the Smokerlyzer® device at each visit.\n2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient\n3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided'}], 'interventions': [{'name': 'knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['adverse outcomes related to expired maternal carbon monoxide and fetal carboxyhemoglobin levels'], '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.', 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Rachel G Sinkey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Maternal-Fetal Medicine Fellow', 'investigatorFullName': 'Rubymel J Knupp', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}