Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smoking Cessation Intervention in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Smoking Cessation
Intervention Behavioral: text messages focused on smoking cessation and pregnancy
Enrollment 49
Recruitment Details  
Pre-assignment Details 23 patient were randomized to the texting group and 26 to the control. However, 9 in the texting group and 10 in the controls did not follow up for any study procedures of data collection, so we do not have data to report on them.
Arm/Group Title Texting Group Control Group
Hide Arm/Group Description

text messages focused on smoking cessation and pregnancy

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 text messages
Period Title: Overall Study
Started 23 26
Completed 14 16
Not Completed 9 10
Reason Not Completed
Withdrawal by Subject             9             10
Arm/Group Title Texting Group Control Group Total
Hide Arm/Group Description

text messages focused on smoking cessation and pregnancy

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 text messages Total of all reporting groups
Overall Number of Baseline Participants 14 16 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
16
 100.0%
30
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
Female
14
 100.0%
16
 100.0%
30
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  71.4%
13
  81.3%
23
  76.7%
White
3
  21.4%
3
  18.8%
6
  20.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   7.1%
0
   0.0%
1
   3.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 16 participants 30 participants
14
 100.0%
16
 100.0%
30
 100.0%
1.Primary Outcome
Title Exhaled Carbon Monoxide Levels
Hide Description self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Texting Group Control Group
Hide Arm/Group Description:

text messages focused on smoking cessation and pregnancy

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 text messages
Overall Number of Participants Analyzed 14 16
Measure Type: Count of Participants
Unit of Measure: Participants
8
  57.1%
5
  31.3%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Texting Group Control Group
Hide Arm/Group Description

text messages focused on smoking cessation and pregnancy

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 text messages
All-Cause Mortality
Texting Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Texting Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Texting Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/16 (0.00%) 
Due to challenges with recruitment and retention, the study was underpowered to detect statistical differences.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Research Nurse
Organization: Saint Louis University
Phone: 314-977-2090
EMail: jathompson@slu.edu
Layout table for additonal information
Responsible Party: Katherine Mathews, MD, St. Louis University
ClinicalTrials.gov Identifier: NCT03024606     History of Changes
Other Study ID Numbers: 23943
First Submitted: January 13, 2017
First Posted: January 19, 2017
Results First Submitted: June 14, 2017
Results First Posted: October 24, 2018
Last Update Posted: October 24, 2018