Persson 2013.
| Methods | Cluster‐randomised controlled trial conducted in Quang Ninh province, Vietnam | |
| Participants | A cluster constituted the geopolitical unit known as a commune (which includes a Commune Health Centre (CHC) in each commune); 99 communes were included in the trial and 44 were allocated to intervention and 46 to control. All mother‐newborn pairs within the study area with births from July 2008 to June 2012 were eligible to be included in the trial. 22,561 births were registered in the study area during the trial period | |
| Interventions | Intervention: consisted of facilitated work of maternal and child stakeholder groups on the commune level that included identification of local perinatal health problems followed by a problem‐solving cycle. Lay women were recruited from Women's Unions in the province to act as facilitators in supporting CHC staff and key commune stakeholders in improving perinatal healthcare practices. Training of facilitators involved theoretical sessions, group discussions, role‐plays, and field practices, which covered topics of group dynamics, quality improvement methods, and basic evidence‐based perinatal care. Each intervention commune included a Maternal and Newborn Health Group, which consisted of 8 members (including 3 CHC staff, 1 village health worker of the commune, 1 population collaborator, the chairperson or vice chairperson of the commune, and 2 WU representatives). Facilitators mainly mobilised these groups by using the plan‐do‐study‐act cycle to identify and prioritise local perinatal health problems and to accomplish improvement cycles Control: no details were provided (n = 10,655 births in control communes) |
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| Outcomes | Primary outcome: neonatal mortality Secondary outcomes: care‐seeking behaviour (attendance to antenatal care, tetanus immunisation during antenatal care, reported material and financial preparedness for birth delivery, institutional delivery), exclusive breastfeeding (initiation of breastfeeding within 1 hour), temperature control at delivery, home visit by midwife first week after delivery, perinatal health knowledge of primary health staff |
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| Notes | Funding: funded by the Swedish International Development Cooperation Agency (Sida), Swedish Research Council, and Uppsala University. The funding agency had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "an individual randomisation was not possible, due to the intervention on the commune level"; "A random number list was used to subsequently allocate "intervention" or "control" to the list of communes" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "the sequence was concealed until the intervention was assigned; otherwise the allocation was not masked" Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "the training program of the facilitators included theoretical sessions, group discussions, role‐plays, and field practice" Comment: blinding of personnel was not possible due to the training element of the trial; there was no mention of blinding of participants; this was probably done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: all communes were accounted for; due to the nature of the trial, the attrition rate cannot be calculated (i.e. recorded only birth outcomes with no mention of loss to follow‐up for mothers). Not enough information |
| Selective reporting (reporting bias) | Low risk | Comment: this is a registered trial, and this study has reported all outcomes mentioned in the protocol |
| Other bias | Low risk | Comment: study seems to be free from other biases |