Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in the Number of Cigarettes Smoked Per Day |
Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report the number of cigarettes smoked per day. Data will be presented as the change in the number of cigarettes smoked per day compared between groups. |
up to 50 weeks (third trimester (28-36.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
|
Primary |
Change in Urine Cotinine Concentration Level |
Participants will provide a urine sample to be measured by litmus analysis during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The litmus levels range from 0 (minimum) to 6 (maximum). Data will be presented as the change in cotinine levels by the litmus measure over the course of the study compared between groups. |
up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
|
Primary |
Change in Electronic Cigarette Usage Per Day |
Participants will be asked during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks) to self-report electronic cigarette (e-cig) usage per day. Data will be presented as the change in e-cig usage per day compared between groups. |
up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
|
Primary |
Change in Cigarette Dependence |
Participants will complete the Fagerstrom Test for Cigarette Dependence during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks seven questions related to cigarette dependency. For scoring, yes/no questions are scored from 0 to 1, and multiple choice questions from 0 to 3. Items are then summed to yield a total score of 0-10. The higher the total score, the more intense the patient's nicotine dependence. Any score greater than 8 is considered high dependency, a score of 5-7 is considered moderately dependent, 3-4 is low to moderate dependence and 1-2 is low dependence. Data will be presented as the change in cigarette dependency over time compared between groups. |
up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus postpartum visit (2-8.6 weeks after delivery)) |
|
Primary |
Change in Electronic Cigarette Dependence |
Participants will complete the Penn State Electronic Cigarette Dependence Index (PSECDI) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey instrument asks ten questions and responses are scored on a scale from zero to 20. Summed scores correlate to a dependence category; 0-3 is not dependent, 4-8 is low dependence, 9-12 is medium dependence, and above 12 is high dependence. Data will be presented as the change in electronic cigarette dependency over time compared between groups. |
up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
|
Secondary |
Change in Maternal Depression Over Time |
Participants will complete the Edinburgh Postnatal Depression Scale (EPDS) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 10 multiple choice questions with scores for each question ranging from 0-3. Scores are then summed for a total score, ranging from 0-30. Questions 1, 2 & 4 are scored 0-3 with the first answer to each question scored as 0 and the fourth answer scored as 3. Questions 3 & 5-10 are reverse scored, with the first answer to each question scored as 3 and the fourth answer scored as 0. A score of 10 or greater is interpreted as "possible depression". A score of greater than 0 on item 10 indicates "suicidal thoughts". Data will be presented as the change in depression over time compared between groups. |
Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
|
Secondary |
Change in Maternal Anxiety Over Time |
Participants will complete the Generalized Anxiety Disorder 7-item (GAD-7) scale during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 7 questions scored between zero and 21. A score of 5-9 indicates mild severity, 10-14 is moderate, and 15 and greater is considered severe. Data will be presented as the change in anxiety over time compared between groups. |
Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
|
Secondary |
Change in Maternal Perceived Stress Over Time |
Participants will complete the Perceived Stress Scale 4-item (PSS4) during the second trimester, third trimester, two months postpartum and six months postpartum (up to 50 weeks). The survey consisted of 4 questions scored between zero and 16. Higher scores are correlated with more stress. Data will be presented as the change in stress over time compared between groups. |
Up to 50 weeks (enrollment (up to 31.6 weeks gestation) minus first postpartum visit (2-8.6 weeks after delivery)) |
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