Darmstadt 2010.
| Methods | Cluster‐randomised controlled trial conducted in Mirzapur, Bangladesh | |
| Participants | All married women of reproductive age (15 to 49 years). 12 unions were randomised to intervention or comparison arm. Total numbers of participants were 9987 and 11,153 in intervention and comparison arms, respectively | |
| Interventions | In the intervention arm (n = 9987), community health workers (CHWs) identified pregnant women; made 2 antenatal home visits to promote birth and newborn care preparedness; made 4 postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance Control (n = 11,153): newborns in the control arm received the usual health services provided by the government, non‐governmental organisations, and private providers CHWs were trained for 36 days on pregnancy surveillance, counselling and negotiation skills, essential newborn care, neonatal illness surveillance, and management of illness based on a clinical algorithm adapted from Integrated Management of Childhood Illness. After initial training and evaluation, routine monitoring and refresher training were provided each fortnight |
|
| Outcomes | Primary outcomes: antenatal and immediate newborn care behaviours, knowledge of danger signs, care‐seeking for neonatal complications, neonatal mortality | |
| Notes | Funding: supported by the Wellcome Trust ‐ Burroughs Wellcome Fund Infectious Disease Initiative 2000 and the Office of Health, Infectious Diseases and Nutrition, Global Health Bureau, United States Agency for International Development (USAID) through the Global Research Activity Cooperative agreement with the Johns Hopkins Bloomberg School of Public Health (award HRN‐A‐00‐96‐90006‐00). Support for data analysis and manuscript preparation was provided by the Saving Newborn Lives programme through a grant by the Bill & Melinda Gates Foundation to Save the Children‐US. Sponsors had no role in study design, study implementation, or data analysis or interpretation, or in the decision to publish the paper | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "12 rural unions, which were randomly allocated to either comparison or intervention arm using a computer‐generated pseudo‐random number sequence without stratification or matching" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Since this was a cluster‐randomised trial, allocation concealment should not be an issue, as in this design, all clusters are randomised at once |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "blinding was unachievable given the nature of the intervention" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "data, including sings and symptoms of illness leading to deaths, were collected by separate interviewers who were trained in verbal autopsy data collection for six days" Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition (7.8%) and reasons were mentioned |
| Selective reporting (reporting bias) | Low risk | Comment: this is a registered trial, and the study has reported all outcomes mentioned in the protocol |
| Other bias | Low risk | Study seems to be free from other biases |