Baqui 2008 (a).
| Methods | Cluster‐randomised controlled trial conducted in 3 rural subdistricts (Beanibazar, Zakiganj, Kanaighat) of Sylhet district of Bangladesh | |
| Participants | All married women of reproductive age (15 to 49 years) were eligible to participate. Total of 24 clusters: 12 in the intervention group and 12 in the control group. Total number of participants in all study groups was 113,816 | |
| Interventions | The intervention was delivered through CHWs who identified pregnancies and provided the intervention package. Study had 3 arms (i.e. HC, CC, and control). Interim sample household surveys were done to measure intervention inputs, coverage, and changes in key newborn care practices in all 3 study arms Intervention (n = 2846 live births): HC model: in this study arm, CHWs identified pregnancies through routine surveillance during visits to each household once every 2 months; promoted birth and newborn care preparedness through 2 scheduled antenatal and 3 early postnatal home visits; and provided iron and folic acid supplements during birth and newborn care preparedness visits. Home screening/management/referral of sick newborns was also included Control (n = 2638 live births): families in the control arm received the usual health services provided by the government, non‐governmental organisations, and private providers |
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| Outcomes | Primary outcomes: neonatal mortality, stillbirth, abortion Secondary outcomes: antenatal visits from trained providers, use of iron and folic acid supplements, use of clean cord cutting instruments, delays in newborn first bath, breastfeeding within 1 hour of birth, tetanus‐toxoid immunisation coverage |
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| Notes | Refresher training sessions for management of maternal and newborn complications were provided for government health workers in all 3 study arms Two intervention arms were separately analysed with the control arm Funding: study sponsors had no role in study design, data collection, analysis, interpretation, or dissemination, nor in the decision to submit this paper for publication |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "...computer‐generated pseudo‐random number sequence without stratification or matching. The computer‐generated randomisation was implemented by a study investigator who had no role in the implementation of the study" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Comment: since this is 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 | Comment: due to the nature of the trial, participants and personnel could not be blinded |
| 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 | Attrition (12.3%) was described with reasons. Exclusion data were not reported, nor were reasons |
| 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 | Quote: "a potential limitation was that we relied on retrospective recall for information about changes in maternal and newborn‐care practices and neonatal mortality. We used standardised data collection methods, and any potential recall lapses were expected to be similar across the study arms" Comment: probably done |