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Trial record 26 of 2034 for:    Smoking Cessation

Smoking Cessation Intervention in Pregnant Women

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ClinicalTrials.gov Identifier: NCT03024606
Recruitment Status : Completed
First Posted : January 19, 2017
Results First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Katherine Mathews, MD, St. Louis University

Brief Summary:
The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: text messages focused on smoking cessation and pregnancy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Smoking Cessation Following Text Message Intervention in Pregnant Women
Study Start Date : March 2014
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : June 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: texting group
text messages focused on smoking cessation and pregnancy
Behavioral: text messages focused on smoking cessation and pregnancy
The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.

No Intervention: control group
No text messages



Primary Outcome Measures :
  1. Exhaled Carbon Monoxide Levels [ Time Frame: 1 month ]
    self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a confirmed pregnancy,
  • English speaking,
  • 18-55 years of age,
  • Are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation,
  • Have a cellular phone that is capable of receiving text messages, and be willing to pay for any related fees for testing.
  • Willing and able to commit to the visit schedule

Exclusion Criteria:

  • Gestational age > 35 weeks at quit date
  • If subjects are in the pre-contemplative or contemplative stages of change or have already received 30 minute pharmacy education targeted for the quit date in this pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024606


Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Katherine J Mathews, MD St. Louis University
  Study Documents (Full-Text)

Documents provided by Katherine Mathews, MD, St. Louis University:

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Responsible Party: Katherine Mathews, MD, Principal Investigator, St. Louis University
ClinicalTrials.gov Identifier: NCT03024606     History of Changes
Other Study ID Numbers: 23943
First Posted: January 19, 2017    Key Record Dates
Results First Posted: October 24, 2018
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No