Memon 2015.
| Methods | Study of exploratory quasi‐experimental design to determine the impact of community‐based perinatal and newborn preventive care package on perinatal and neonatal mortality in Northern Parkistan | |
| Participants | Overall population for the study district was 283,324, comprising 35,641 households; the intervention area comprised 16,802 households and a population of 137,781; the control area covered 18,659 households with a population of 145,543. A total 165 LHWs and CHWs were trained with additional curriculum on essential newborn care to deliver the intervention package | |
| Interventions | Intervention package: Lady Health Workers and community health workers were trained on causes of perinatal and newborn mortality and risky maternal and newborn care practices, and they were trained to educate families on these topics. They were trained to deliver the intervention package that involves developing awareness related to positive maternal and newborn healthcare practices at a household level, involving the importance of seeking antenatal care, adequate nutrition during pregnancy and lactation, and skilled birth attendance. The intervention package was implemented through monthly household visits, one‐to‐one counselling sessions with pregnant women, and video sessions in communities (group education) (n = 849 total births in intervention areas post intervention) Control: these areas received the routine services of government and non‐government‐provided services (n = 863 total births in control areas post intervention) | |
| Outcomes | Outcome measures: change in maternal and newborn practices, perinatal and neonatal mortality rates | |
| Notes | Funding: jointly funded by University Research Council, Aga Khan University, Pakistan, and Saving Newborn Lives Initiative, Save the Children, US. There is no statement related to involvement of these funding parties in design and conduct of the study | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "the overall population of 283,324 comprising 35,641 households located in the study district was allocated to intervention and control areas based on geographical proximity to avoid contamination and manage logistics and undertake the study with limited resources available"; "forty‐eight villages were randomly selected for this phase" Comment: probably not done |
| Allocation concealment (selection bias) | High risk | Comment: this is a quasi‐experimental design |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
| 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 | Attrition of pre‐intervention and post‐intervention populations 4.4%; no explanation for losses to follow‐up Comment: insufficient information to permit judgement |
| 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 | Study seems to be free from other biases |