Table 2.
Feasibility of Study Protocol (N = 46)
| Total | Progesterone n = 24 | Placebo n = 22 | p c | |
|---|---|---|---|---|
| Compliance (mean ± SD) | ||||
| Number of postpartum visits attended (range: 0–5) | 4.5 (1.1) | 4.5 (1.1) | 4.4 (1.2) | .5990 |
| Doses of medication taken (range: 0–56) | 38.2 (20.3) | 38.9 (22.3) | 37.5 (18.3) | .8154 |
| EDCs completed (range: 0–84) | 61.3 (22.7) | 60.9 (21.8) | 61.8 (24.3) | .9002 |
| Acceptability (mean ± SD) | ||||
| Acceptability scorea at week 4, n = 38 | 3.6 (0.3) | 3.6 (0.3) | 3.5 (0.3) | .2205 |
| Acceptability scorea at week 12, n = 39 | 3.5 (0.3) | 3.6 (0.3) | 3.5 (0.4) | .1354 |
| Individual questionsb n (%) | ||||
| 1. How willing would you be to participate in a study like this again? | 37 (80.4) | 20 (83.3) | 17 (77.3) | |
| 2. Overall, how much of a burden was it to participate in this study? | 6 (13.0) | 2 (8.3) | 4 (18.2) | |
| 3. Overall, how much did participating in this study interfere with your usual activities? | 1 (2.2) | 0 | 1 (4.5) | |
| 4. How difficult was it to use the cell phone to complete the study questionnaires? | 1 (2.2) | 1 (4.2) | 1 (4.5) | |
| 5. Overall, how much were you annoyed with the number of times the cell phone beeped during the day? | 1 (2.2) | 0 | 1 (4.5) | |
| 6. How difficult was it to take the study-supplied medication? | 6 (13.0) | 2 (8.3) | 4 (18.2) | |
| 7. How difficult was it to notify the study staff of your child’s birth? | 3 (6.5) | 2 (8.3) | 1 (4.5) | |
| 8. Overall, how much do you think this study has helped you stay smoke- free after your baby was born? | 32 (69.6) | 20 (83.3) | 12 (54.5) | |
| 9. Overall, how difficult was it to work with study staff? | 0 (0) | 0 (0) | 0 (0) | |
EDC = electronic data capture.
aDefined as the average of nine questions (1 and 8 reversed). Scores range between 1–4 with 1 = low acceptability and 4 = high acceptability.
bResponses of “moderately” or “extremely” on week 12 satisfaction survey.
cTwo group t test.