Mejdoubi 2014.

Methods	A single‐blind, parallel‐group, randomised controlled trial to assess the VoorZorg nurse visitation programme, and its effects on smoking, pregnancy outcomes and breastfeeding, carried out in 20 different municipalities, the Netherlands between 2007 and 2009.
Participants	Inclusion criteria: Age < 26 years, <= 28 weeks pregnancy with the first child, low educational level and some knowledge of the Dutch language. Women had to have at least 1 risk factor: no social support, previously or currently experiencing domestic violence, psychosocial symptoms, unwanted and/or unplanned pregnancy, financial problems, housing difficulties, no education and/or employment and alcohol and/or drug use. Exclusion criteria: Not stated. Recruitment: Women were actively recruited by GPs and midwives, with 460 pregnant women randomised (C = 223 I = 237). Baseline characteristics: Attempted to quit smoking (C = 80% I = 82%). Stopped smoking after aware of the pregnancy (C = 20% I = 13%). Mean age (C = 19.2 I = 19.5) Employed C = 28% I = 29%, Prevocational Education (C = 96% I = 94%) (rest primary school only). Progress + coding: Low SES due to inclusion criteria being presence of at least 1 risk factor.
Interventions	Control: UC, which for pregnant women in the Netherlands includes maternal health care delivered by a midwife. Intervention: Women in the intervention group were offered,in addition to UC, approximately 10 home visits during pregnancy, 20 during the first year and 20 during the second life year of the child by trained, specialised VoorZorg nurses. According to the protocol, 6 domains were discussed during the home visits: (1) the health status of the mother, (2) the child's health and safety,(3) the personal development of the mother, (4) the role of the mother, (5) the mother's relation with her partner, family and friends and (6) the use of (health) care organisations. Main Intervention strategy: Maternal Health intervention with smoking cessation component: social support (single) vs UC Intensity: Frequency (C = 0, I = 6) Duration (C = 0, I = 4). Intervention provided by study staff: efficacy study
Outcomes	Self‐reported abstinence in late pregnancy* (32 weeks of pregnancy), abstinence at 2 months post birth (0‐5 months pp)*, mean number of cigarettes smoked per day*, birthweight, prematurity, LBW (< 2500 g), weeks of gestation, adverse pregnancy outcomes, small for gestational age and breastfeeding. Birth outcomes not included in this review as other aspects of intervention other than smoking cessation may have contributed to these outcomes.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Participants were randomly assigned into the control or intervention group after being stratified by region and ethnicity by use of the computer‐generated list of random numbers.
Allocation concealment (selection bias)	Low risk	Randomisation was performed with a computer‐generated list, so assume researcher was blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Last observation carried forward approach was conducted to replace missing data.
Selective reporting (reporting bias)	Low risk	All outcomes are reported.
Other bias	Unclear risk	No other bias detected.
Biochemical validation of smoking abstinence (detection bias)	High risk	Cigarette smoking was assessed by self‐report measure.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Interviewers were blinded from allocation, however as the intervention was health education is was not feasible to blind women or providers.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Interviewers were blinded at follow‐up.
Incomplete implementation	Low risk	Good implementation.
Equal baseline characteristics in study arms	Low risk	Baseline characteristics appeared to be equal.
Contamination of control group	Low risk	Main component of the intervention is home visitation.