Kirkwood 2013.

Methods	Parallel‐arm cluster‐RCT conducted in Ghana between Nov 2008 and Dec 2009.
Participants	Sample size: 98 clusters (18,609 individuals). Clusters: residential zones. Individuals: all pregnant women and newborn babies living in the Newhints zones, where pregnancies ended between November 2008 and December 2009.
Interventions	Target: health system (added home visits by community‐based surveillance volunteers) and community (IEC). Arm 1 (49 clusters, 9174 women): training of community‐based surveillance volunteers to identify pregnant women in their community and to undertake 2 home visits during pregnancy and 3 visits after birth on days 1, 3, and 7, to promote essential newborn‐care practices, and to assess and refer sick newborn babies. Arm 2 (49 clusters, 9435 women): control (no intervention).
Outcomes	Trial primary outcome: neonatal mortality rate and coverage of key essential newborn‐care practices. Review outcomes reported: Primary: ANC coverage (at least 4 visits). Secondary: health facility deliveries, neonatal mortality. Other: coverage of key essential newborn care practices. Follow‐up: 2 home visits during pregnancy and 3 visits after birth on days 1, 3, and 7.
Notes	Funders: WHO, Save the Children’s Saving Newborn Lives Programme from the Bill & Melinda Gates Foundation, and the UK Department for International Development.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"computer generated randomisation."
Allocation concealment (selection bias)	Low risk	An independent epidemiologist conducted the randomisation.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Not described.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Not described.
Recruitment bias (for cluster RCTs)	Low risk	None noted.
Incomplete outcome data (attrition bias) All outcomes	Low risk	3 groups of pregnancies were not included in the analysis of NMR: 908 (5%) women were lost to follow‐up during pregnancy; 1216 (7%) had pregnancies that ended early and did not result in a livebirth or stillbirth; and 156 (< 1%) women moved, resulting in a change of treatment groups.
Selective reporting (reporting bias)	Low risk	Most relevant outcomes reported.
Analysis bias	Low risk	Analysis appropriate for clusters; ICC reported; ITT analysis performed.
Other bias	Low risk	No baseline imbalances noted.
Overall risk assessment	Low risk	No serious risk of bias concerns.