Bhutta 2008.
| Methods | Pilot clustered‐randomised trial from Hala and Matiari subdistricts of Sind, Pakistan | |
| Participants | Target population consisted of pregnant women. 24 village clusters were identified at a primary care facility. Out of those, 8 clusters were randomly selected for this pilot study. 4 districts chosen to receive intervention were matched with 4 control clusters for population size and birth and neonatal mortalities rates (5134 births) | |
| Interventions | Intervention: promotion of maternal nutrition and rest, early breastfeeding (within first hour), colostrum administration (avoidance of pre‐lacteal feeds), thermoregulation, home care for low birth weight infants, treatment of pneumonia with oral trimethoprim‐sulphamethoxazole (TMP‐SMX), recognition of danger signs, training in group counselling and communication strategies (n = 2672 births) Control: routine care (n = 2462 births) The following activities were conducted in both intervention and control groups: promotion of antenatal care, iron and folate use during pregnancy, immediate newborn care, cord care, promotion of exclusive breastfeeding |
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| Outcomes | Primary outcomes: stillbirths, early neonatal deaths, late neonatal deaths, total neonatal deaths, perinatal deaths | |
| Notes | Local health workers (LHWs) were encouraged to visit all pregnant women twice during pregnancy, within 24 hours of birth, and 4 times in the first postnatal month, and were encouraged to link up with local Dais (traditional birth attendants). LHWs were supported by the creation of voluntary community health committee, which helped in conducting community education group sessions Funding: the Hala project is supported by a collaborative grant from WHO and the Saving Newborn Lives (SNL) programme of Save the Children (USA), funded by the Bill & Melinda Gates Foundation |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "eight clusters were randomly selected for this pilot study"; "subsequently, the four clusters chosen to receive the intervention were matched with four control clusters" Comment: probably not 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 | Unclear risk | Comment: insufficient information to permit judgement |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "cross‐sectional surveys of all households were conducted by a separate team in both the middle (June–July 2004) and at the end (August –September 2005) of the pilot study to collect data on births, deaths and care‐seeking behaviour in the preceding 12 months" Comment: done |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
| Selective reporting (reporting bias) | Low risk | Comment: study reported all outcomes outlined in the protocol |
| Other bias | Low risk | Comment: study seems to be free from other biases |