Rigotti 2006.

Methods	Randomised controlled trial of a telephone counselling intervention to support women to stop smoking and prevent relapse during pregnancy and postpartum. Study conducted in a network‐managed care organisation and a group of 65 community‐based prenatal care practices Massachusetts, New England (USA), with recruitment from September 2001 to July 2004.
Participants	Inclusion criteria: Pregnant smokers (at least 1 cigarette in the past 7 days), at least 18 years of age, 26 weeks or less gestation, willing to consider altering smoking during pregnancy, reachable by telephone, English speaking and expected to live in New England for the next year. Exclusion criteria: Not further specified. Recruitment: Smokers initially identified on 'Obstetric Risk Assessment' form, yielded low recruitment so 65/140 obstetric or family practices agreed to refer patients and 35 sent in 1 or more referral forms. 1444 pregnant smokers were referred to the study and 665 assessed as eligible. 442/446 (66%) agreed to participate and were randomised (C = 222, I = 220). Baseline characteristics: Mean cigarettes per day before pregnancy: C = 20.8, I = 20.9; Current mean cigarettes per day: C = 10, I = 10.4; Partner smoking: C = 62%, I = 71%. Mean age: C = 28.1, I = 28.9; Mean years education: C = 13, I = 13.1; White: C = 87%, I = 88%; Private health insurance: C = 70%, I = 75%. Depression in last month: C = 1.3%, I = 1.3%. Progress + coding: None.
Interventions	Control: In addition to UC, the control group were mailed a validated pregnancy‐tailored smoking cessation booklet, and their prenatal care providers were sent the ACOG smoking cessation practice guideline, with a reminder to address smoking at the participant's visits. The enrolment call concluded with a trained counsellor providing brief smoking counselling (less than 5 mins). Smokers who requested further assistance were referred to the Massachusetts telephone quit‐line. Intervention: The intervention group received as for the control group, plus a series of telephone calls accompanied by additional mailed written materials. Each participant had a dedicated counsellor who offered up to 90 mins of counselling during pregnancy and up to 15 mins over the 2 months postpartum. The trained counsellor tailored the call to the participant's needs, consistent with the 5‐step smoking cessation guideline, and drew on social learning theory and the transtheoretical model of change, the health belief model, and the principles of MI. Main intervention strategy: Counselling (multiple intervention) compared to a less intensive intervention. Intensity: Frequency (C = 2, I = 4), Duration (C = 1, I = 3). Intervention provided by dedicated project staff: Efficacy study.
Outcomes	Biochemically validated 7‐day point prevalence abstinence at 28 weeks to term (late pregnancy*), and 3 (0‐5) months postpartum*. Also measured reduction in smoking (proportion > 50% reduction in cigarettes per day*), sustained abstinence at both time points, and number of quit attempts. Self‐efficacy and social support at baseline and follow‐up. Concerns about weight gain reported in an associated reference (Berg 2008). Women's satisfaction with the intervention.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated.
Allocation concealment (selection bias)	Low risk	Stated that recruiters were not aware of group allocation.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Attrition: 21/442 (5%) were excluded from the analysis due to miscarriage (C = 10/220, I = 11/222). 113 women did not have final assessment due to refusal (22%), baby born before assessment or lost to follow‐up, but were included in the final analysis (ITT analysis) and in this review (C = 209, I = 212). Missing data (up to 30%) for outcomes measured in the postnatal period.
Selective reporting (reporting bias)	High risk	Not clear if all outcomes reported.
Other bias	Low risk	No other bias detected.
Biochemical validation of smoking abstinence (detection bias)	Low risk	Salivary cotinine (<= 20 ng/mL cut‐off) confirmation in 66%, and those refusing to provide a sample were included as continuing smokers.
Blinding of participants and personnel (performance bias) All outcomes	High risk	All providers and women sent smoking cessation practice guideline.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not reported.
Incomplete implementation	Low risk	Mean number of calls received was 5.
Equal baseline characteristics in study arms	High risk	Both groups were similar, though the intervention group had a significantly higher proportion of women who had made a quit attempt this pregnancy and had social support to quit from partner and significant differences in parity, gestation, and partner smoking
Contamination of control group	Low risk	Trained counsellors delivering intervention not UC givers.