| Methods | Ershoff 1989 trial data of relapse prevention in the women who had spontaneously quit smoking in early pregnancy | |
| Participants | The pre-pregnancy smokers who had quit spontaneously before the first antenatal contact: 110 + 108, with losses due to termination (5); miscarriage (17) and transfer to alternative prenatal care (25) leaving 87 + 84 | |
| Interventions | See Ershoff 1989 except that the intervention group received the first 4 booklets at the first interview with booklets 5 to 8 mailed weekly thereafter; control group were congratulated on quitting and given a tip sheet on “staying quit”. Intensity rating: I = 3, C= 2 | |
| Outcomes | Smoking data validated with urinary cotinine measurement, no perinatal data | |
| Notes | Detailed process evaluation and analysis of factors promoting or inhibiting cessation and maintenance of non-smoking | |
| Risk of bias | ||
| Item | Authors’ judgement | Description |
| Adequate sequence generation? | No | No information. |
| Allocation concealment? | No | See Ershoff 1989 above. |
| Blinding? Women and clinical staff |
No | Neither caregiver nor women were blinded. |
| Incomplete outcome data addressed? All outcomes |
No | 22% attrition. No ITT analysis. |
| Free of selective reporting? | Unclear | None apparent. |
| Free of detection bias? | Yes | Biochemical validation by urinary cotinine levels. |