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) |
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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 |
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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 |