Waiswa 2015.
| Methods | Cluster‐randomised controlled trial in Iganga and Mayuge districts, eastern Uganda (The Ugandan Newborn Study) | |
| Participants | This study was implemented within the Health Demographic Surveillance Site (HDSS) in eastern Uganda, which comprises 65 villages. The cluster unit for the study was the village; 63 of these villages were randomly allocated to intervention (n = 31) and control (n = 32). The trial included all consenting pregnant women and their newborns residing in the HDSS. A baseline survey was conducted involving women with a live birth within 4 months of the survey (intervention = 194, control = 201), and an end line survey was given amongst women who had had a live birth within 12 months of the survey (intervention = 894, control = 893) | |
| Interventions | Intervention: the UNEST package involved training community health workers for 5 days on the package, which involved identifying pregnant women in their community and undertaking 2 home visits during pregnancy and 3 visits after birth, at or close to 1, 3, and 7 days. These visits by CHWs offered women preventive and promotive care as well as counselling. Health system strengthening was also undertaken for all public and private health facilities in and around the study area. Training modules included goal‐oriented antenatal care, management of maternal complications, infection prevention, management of normal labour and partograph use, neonatal resuscitation, care of the sick newborn, and extra care for small babies via kangaroo mother care (n = 894 women gave birth at end line) Control: women and their newborns in comparison villages had access to standard health services, overseen by the district health team, in addition to improved health facilities (n = 893 women gave birth at end line) |
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| Outcomes | Primary outcomes: improved coverage of services for antenatal care, birth preparedness, skilled attendance at delivery, postnatal care, increase in healthy practices (breastfeeding, thermal care, hygiene) | |
| Notes | Funding: funds provided by Save the Children through a grant from the Bill & Melinda Gates Foundation. This supplement was funded by Save the Children’s Saving Newborn Lives programme through a grant from the Bill & Melinda Gates Foundation. 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) | Low risk | Quote: "each of the 63 villages in the HDSS was randomly allocated to the intervention or control arm, without any stratification or matching due to the relatively large number of study units. Computer‐generated restricted randomisation was done in a one‐to‐one ratio..." Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Comment: there is no mention of concealing or masking; however this is a cluster‐randomised controlled trial, and randomisation of clusters and therefore allocation concealment should not be an issue |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: due to the nature of the intervention package, it does not appear realistic to employ blinding; however there is insufficient information |
| 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 | Comment: loss to follow‐up and attrition rate were not reported and cannot be calculated due to the method of baseline and end line comparisons |
| Selective reporting (reporting bias) | Low risk | Comment: this is not a registered trial, but outcomes mentioned in the methods are reported in the results |
| Other bias | Low risk | Study seems to be free from other biases |