Table 4.
Adverse events
| Treatment details | Pregnancy outcomes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ID | Gestational age (GA) at Rand | GA at last sessiona | Smoking status at last session | Pre-eclampsia | Placental abnormality | Preterm birth | Final GA | SG A | Birthweight (g) | NICU admission | Fetal loss GA |
| CBT only | |||||||||||
| A | 21.7 | 27.4 | Smoking | x | 36.9 | 3289 | |||||
| B | 22.4 | 35.4 | Smoking | x | 36.3 | 2410 | x | ||||
| C | 23.9 | 29.9 | Relapsed | 36.3 | Unknown | 36.3f | |||||
| D | 17.1 | 30.0 | Relapsed | x | 36.1 | 3402 | |||||
| E | 14.4 | 27.6 | Smoking | x | 36.1 | 2863 | |||||
| F | 23.6 | 34.9 | Smoking | x | 36.0 | 2807 | |||||
| G | 16.6 | 32.1 | Relapsed | x | 34.6 | 2240 | x | ||||
| H | 13.1 | 20.1 | Smoking | x | 34.3 | 2410 | x | ||||
| I | 23.0 | 27.1 | Smoking | x | x | 31.9 | 1503 | ||||
| J | 20.9 | 20.9b | Unknown | x | x | 25.4 | 312 | x | 27.0 | ||
| CBT+NRT | |||||||||||
| K | 13.9 | 13.9b,c | Unknown | e | Unknown | e | |||||
| L | 13.0 | 30.3 | Quit | 40.9 | 3033 | x | |||||
| M | 16.9 | 35.1d | Relapsed | 39.3 | x | 2466 | |||||
| N | 14.9 | 32.6 | Relapsed | 39.1 | 4508 | x | |||||
| O | 18.9 | 37.6c | Relapsed | 39.0 | x | 2466 | |||||
| P | 21.3 | 21.3c | Unknown | 39.3 | 2977 | x | |||||
| Q | 14.3 | 27.3 | Relapsed | x | 39.0 | 3995 | |||||
| R | 24.0 | 30.4 | Quit | x | 37.7 | 2523 | |||||
| S | 14.1 | 14.1b | Unknown | 37.4 | x | 2466 | |||||
| T | 22.3 | 31.9 | Smoking | 37.0 | x | 2296 | |||||
| U | 19.0 | 26.3 | Relapsed | x | 36.9 | 2665 | |||||
| V | 15.3 | 15.3c | Unknown | x | 36.7 | 3260 | |||||
| W | 16.1 | 18.0 | Quit | x | 36.7 | 2977 | x | ||||
| X | 17.9 | 32.6 | Relapsed | x | 36.6 | 3289 | |||||
| Y | 21.9 | 28.9 | Relapsed | x | 36.6 | 2126 | |||||
| Z | 22.1 | 33.0 | Relapsed | x | 36.1 | 2722 | |||||
| AA | 15.9 | 23.7 | Relapsed | x | 36.0 | 2580 | |||||
| BB | 21.7 | 35.1d | Smoking | x | x | 36.0 | 2410 | ||||
| CC | 16.6 | 34.0 | Relapsed | x | 35.9 | 2637 | x | 35.9 | |||
| DD | 18.9 | 25.7 | Relapsed | x | 35.0 | 2381 | |||||
| EE | 17.6 | 27.1 | Relapsed | x | 35.0 | 2325 | |||||
| FF | 15.4 | 27.7 | Quit | x | 35.0 | 1361 | x | ||||
| GG | 19.4 | 34.9c | Smoking | x | 34.9 | 2722 | |||||
| HH | 14.4 | 32.1d | Relapsed | x | 34.0 | 2608 | |||||
| II | 14.4 | 27.4 | Relapsed | x | 34.9 | 3090 | x | ||||
| JJ | 14.6 | 29.0 | Relapsed | x | x | 33.9 | 2296 | x | |||
| KK | 20.9 | 34.0 | Quit | x | x | 33.4 | 1701 | x | |||
| LL | 19.1 | 19.1b | Unknown | x | x | 33.3 | 1928 | ||||
| M | 18.4 | 25.3c | Smoking | x | 2098 | x | |||||
| M | 33.1 | ||||||||||
| NN | 18.9 | 32.0c | Quit | x | x | 32.4 | 1106 | x | |||
| OO | 16.0 | 23.3 | Quit | x | 30.7 | 1673 | x | ||||
| PP | 24.0 | 26.9 | Relapsed | x | 29.6 | twins | |||||
| 14.0 | 23.9 | Relapsed | x | 24.0 | 700 | x | |||||
| RR | 19.1 | 22.1 | Relapsed | x | 23.0 | 567 | 23.3 | ||||
Nicotine replacement therapy (NRT) use during the study. None of the participants in the cognitive-behavioral therapy (CBT)-only arm who had adverse events used NRT.
NRT use is unknown due to no contact after randomization. Baby died at 9 days old.
Participant in CBT+NRT arm did not use NRT.
Gestational age at last contact. Participant still reported using NRT. Participant may have used NRT after session but use is unknown.
Participant randomized at 13 weeks; prior to receiving any intervention, underwent ultrasound in which embryonic demise at approximately 7 weeks diagnosed.
Gestational age was approximated from obituary.