Methods |
Setting: Army Medical Center, USA Recruitment: pregnant smokers and recent quitters with partners |
Participants |
316 pregnant recent quitters, 267 continuing smokers (excluded miscarriages); average age 24, average cigs/day prepregnancy 13 |
Interventions |
Both interventions included prepartum and postpartum components, in addition to usual care 1. Women only (WO); 3 counselling calls in pregnancy, 3 postpartum, monthly. Motivational interviewing. Late pregnancy relapse prevention kit 2. Partner‐assisted (PA); as WO, plus advice on using partner as coach, and 6 calls to partner. Cessation support for smoking partners 3. Usual care; provider advice and mailed pregnancy‐specific self‐help |
Outcomes |
Abstinence at week 28 of pregnancy and 12 months postpartum (7‐day PP). Also assessed at 8 weeks, 6 months postpartum Validation: saliva cotinine requested by mail, no difference in return rates, disconfirmation rates not given, only self‐reported rates reported |
Notes |
New for 2009 update End of pregnancy abstinence amongst baseline quitters, combining interventions 1 and 2 versus control in analysis 1.1. No significant effect of either intervention on end of pregnancy abstinence amongst baseline smokers. 12 months postpartum abstinence for those quit at end of pregnancy in analysis 1.2. Abstinence rates not given separately for those quit at randomisation, but ⅔ of end‐of‐pregnancy quitters came from this category, and the prepartum interventions did not increase cessation |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Randomisation method not stated |
Allocation concealment (selection bias) |
Unclear risk |
No details given |
Blinding of participants and personnel (performance bias) All outcomes |
Unclear risk |
No blinding reported |
Blinding of outcome assessment (detection bias) All outcomes |
Unclear risk |
Biochemical validation conducted but not used in outcome data. "Saliva return rates did not differ by condition at either follow‐up", but rates of return low and level of misreport not specified |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
Excluded miscarriages, no other information on losses |