Trial Outcomes & Findings for Smoking Reduction In Gravid Substance Use Disorders (NCT NCT04132232)
NCT ID: NCT04132232
Last Updated: 2024-08-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
74 participants
Primary outcome timeframe
Final measurement (last prenatal care visit or at delivery)
Results posted on
2024-08-05
Participant Flow
Participant milestones
| Measure |
Treatment Group
1. The patient will exhaled into the Smokerlyzer® device will at each visit
2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient
3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.
knowledge 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.
|
Control Group
1. The patient will exhale into the Smokerlyzer® device at each visit.
2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient
3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
37
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
8
|
Reasons for withdrawal
| Measure |
Treatment Group
1. The patient will exhaled into the Smokerlyzer® device will at each visit
2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient
3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.
knowledge 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.
|
Control Group
1. The patient will exhale into the Smokerlyzer® device at each visit.
2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient
3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided
|
|---|---|---|
|
Overall Study
Randomized but met exclusion criteria.
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
Baseline Characteristics
Smoking Reduction In Gravid Substance Use Disorders
Baseline characteristics by cohort
| Measure |
Treatment Group
n=37 Participants
1. The patient will exhaled into the Smokerlyzer® device will at each visit
2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient
3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.
knowledge 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.
|
Control Group
n=37 Participants
1. The patient will exhale into the Smokerlyzer® device at each visit.
2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient
3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
30.3 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
74 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
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Expired Maternal Carbon Monoxide Level at randomization
|
15.4 ppm
STANDARD_DEVIATION 8.8 • n=5 Participants
|
11.2 ppm
STANDARD_DEVIATION 5.5 • n=7 Participants
|
13.4 ppm
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Average number of cigarettes per day at enrollment
|
12.3 cigarettes
STANDARD_DEVIATION 3.8 • n=5 Participants
|
12.6 cigarettes
STANDARD_DEVIATION 4.4 • n=7 Participants
|
12.4 cigarettes
STANDARD_DEVIATION 4.09 • n=5 Participants
|
PRIMARY outcome
Timeframe: Final measurement (last prenatal care visit or at delivery)Population: Participants who had expired carbon monoxide measured at either their last prenatal visit or at delivery.
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
Outcome measures
| Measure |
Treatment Group
n=37 Participants
1. The patient will exhaled into the Smokerlyzer® device will at each visit
2. Exhaled carbon monoxide and fetal carboxyhemoglobin levels will be disclosed to the patient
3. Risks of adverse perinatal outcomes related to maternal carboxyhemoglobin and fetal carboxyhemoglobin level will be provided.
knowledge 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.
|
Control Group
n=36 Participants
1. The patient will exhale into the Smokerlyzer® device at each visit.
2. Exhaled carbon monoxide and fetal carboxyhemoglobin level will NOT be disclosed to the patient
3. No risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin levels will be provided
|
|---|---|---|
|
Prevalence of Smoking ≥ 10 Cigarettes/Day in Each Group at Final Measurement by Exhaled Carbon Monoxide Level
|
22 participants
|
16 participants
|
Adverse Events
Treatment 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