Trial Outcomes & Findings for Smoking Cessation Intervention in Pregnant Women (NCT NCT03024606)
NCT ID: NCT03024606
Last Updated: 2018-10-24
Results Overview
self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
1 month
Results posted on
2018-10-24
Participant Flow
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.
Participant milestones
| Measure |
Texting Group
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.
|
Control Group
No text messages
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
26
|
|
Overall Study
COMPLETED
|
14
|
16
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
Reasons for withdrawal
| Measure |
Texting Group
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.
|
Control Group
No text messages
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
10
|
Baseline Characteristics
Smoking Cessation Intervention in Pregnant Women
Baseline characteristics by cohort
| Measure |
Texting Group
n=14 Participants
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.
|
Control Group
n=16 Participants
No text messages
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 monthself-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels
Outcome measures
| Measure |
Texting Group
n=14 Participants
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.
|
Control Group
n=16 Participants
No text messages
|
|---|---|---|
|
Exhaled Carbon Monoxide Levels
|
8 Participants
|
5 Participants
|
Adverse Events
Texting Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place