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. 2015 Oct 14;2015(10):CD002856. doi: 10.1002/14651858.CD002856.pub3

Mori 2015.

Methods Cluster‐randomised controlled trial in Bulgan, Mongolia.
Participants Pregnant women living in Bulgan, Mongolia.
The unit of randomisation was the Soum and bag, small geographic areas in Mongolia. Each Soum has a healthcare facility where women must register their newborn. 18 geographic areas were randomised, after selection for administrative convenience and to avoid contamination.
501 women (253 women in the intervention group and 248 women in the control group) participated in the study.
Interventions Distribution of maternal and child health handbooks during pregnancy. The MCH handbook logged maternal health and personal information, pregnancy, delivery and postpartum health and weight, dental health, parenting classes, child developmental milestones from 0‐6 years, immunisation records and height and weight charts for children.
Outcomes Primary: number of antenatal visits; proportion of women attending 6 or more antenatal visits. (The national standard for antenatal care in Mongolia is 6 visits.)
Secondary: maternal outcomes: morbidity during pregnancy, mode of delivery, breastfeeding initiation, maternal depression and health (EPDS and GHQ). Infant outcomes: birthweight, Apgar score, NICU admission, neonatal mortality at discharge. Maternal healthy behaviours.
Notes Significant group differences noted for distances travelled to nearest health centre (greater in the intervention group) and for wealth index (the control group was poorer). The authors report that travel time did not function as an effect modifier; however, women from a higher socioeconomic background attended more antenatal care visits.
Trial authors provided unpublished outcome data upon request. The trial statistician (HN) calculated RRs and 95% confidence using the GEE method to adjust for cluster design and baseline differences, including wealth index.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Sequence according to the shuffling of sealed envelopes.
Allocation concealment (selection bias) Low risk Allocation was concealed in sealed envelopes at time of randomisation. All areas were randomised at the same time.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Masking was not possible for this intervention.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Masking was not possible for this intervention.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3 areas were excluded before randomisation; 1 was the subject of a pilot study, and 2 areas were included in another health study. 9 clusters each received the intervention or the control.
Missing outcome data for individual women are reported and minimal.
Selective reporting (reporting bias) Low risk Prespecified outcomes have been reported. Addtional analyses were obtained from the authors upon request. The trial data file has been published online with the trial report.
Other bias Unclear risk The authors reported baseline imbalances between clusters for travel time to health centre and wealth.
The authors reported that recall bias may exist due to data collection at 1 month after birth.
Analyses were undertaken with methods appropriate for cluster trials; the authors used GEE methods to adjust for the effects of cluster design and baseline variables.
A sample size calculation was undertaken and met.
Recruitment bias ‐ All of the eligible women were registered with the health centres in their soums, and had been visited by the doctors. There is a possibility for them to go to another health centre in a different soum for their antenatal visit or any other visit. Recruitment was done by home visiting of their doctors, not by women's visiting health centres, as the home visits are mandatory for these doctors.

EPDS: Edinburgh Postnatal Depression Scale
 GEE: Generalised estimating equations
 GHQ: General Health Questionnaire
 MCH: Maternal and Child Health
 NICU: neonatal intensive care unit
 RR: risk ratio