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. 2019 Nov 5;2019(11):CD007647. doi: 10.1002/14651858.CD007647.pub2

Pasha 2013.

Methods Community‐based, 2‐arm, cluster‐randomised trial that tested whether a community‐ and facility‐based approach can improve pregnancy outcomes in low‐resource settings where there is limited access to quality obstetrical and neonatal care
Participants This trial included all pregnancies of residents in 106 clusters, ranging from 6 clusters in Argentina to 24 in Pakistan, which were randomised with 53 in each treatment group. Outcomes were recorded for all women with newborns at ≥ 1000 grams and/or > 28 weeks who consented to be included in the study. A total of 70,351 pregnant women were screened in the intervention clusters and 66,830 in the control clusters (59,189 and 57,929 women in the intervention and control clusters, respectively, were eligible and consented)
Interventions Intervention: each cluster included a cluster team that comprised healthcare providers, local residents, and study personnel to develop and implement comprehensive interventions to improve the quality of obstetrical and neonatal care. These teams worked within their community and local healthcare system to facilitate a multi‐faceted intervention that involved 2 components. The first component involved community mobilisation to establish village core groups and strengthen community capacity to identify needs and barriers related to obstetrical and neonatal care. Each village core group was trained to move through a cycle to organise, plan, explore, act on, and evaluate perinatal and maternal outcomes in their community. The second component consisted of Home‐based Life Saving Skills (HBLSS) training for birth attendants and families to recognise danger signs (e.g. prolonged labor, infection) and appropriate stabilisation methods that can be employed in homes and in first‐level care facilities. This component also involved improvement of quality care through a combination of facility staff Emergency Obstetric and Newborn Care (EmONC) training for clinical care for the major causes of perinatal and maternal mortality. This EmONC trial utilised a train‐the‐trainer model, the aforementioned 2 components of intervention training were combined, and this trial emphasised the Community Action Cycle and relevant HBLSS modules
Control: some clusters were assigned to control with no intervention, and data were collected for comparison (no extensive detail for methods)
Outcomes Primary outcome: perinatal mortality (defined: composite of stillbirth and 7‐day neonatal mortality per 1000 births among births occurring at > 28 weeks' gestation or > 1000 g)
Secondary outcomes: rate of stillbirth (fresh and macerated), 7‐day neonatal mortality, 28‐day neonatal mortality, maternal death
Notes Funding: this trial was funded by grants from the US National Institutes of Health (NIH). The NIH programme officers participated in protocol development and study monitoring and reviewed the manuscript
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomization was performed at the cluster level, stratifying by rates of the primary outcome (stillbirth and early neonatal death) and number of deliveries. The data coordinating centre produced a computer‐generated randomisation algorithm which assigned clusters at a 1:1 ratio within each stratum"
 Comment: probably done
Allocation concealment (selection bias) Low risk Comment: since this was a cluster‐randomised trial, allocation concealment should not be an issue
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "because of the nature of the intervention, there was no masking"
Comment: probably not done
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Comment: insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "an additional 3,139 (4.5%) and 2,862 (4.3%) deliveries in intervention and control clusters were excluded at delivery due to missing data or other ineligibility criteria"
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