Ayiasi 2016.
| Methods | Randomised community intervention trial conducted in Masindi and Kiryandongo districts, Uganda | |
| Participants | Pregnant women were recruited during their first antenatal visit; in total 1644 were enrolled (control = 893, intervention = 751) 16 health centres were randomly and equally assigned to 1 of 2 arms: the intervention arm or the control arm 48 Village Health Teams (VHTs) were selected for training |
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| Interventions | Intervention arm: received a package consisting of (1) VHT making home visits to provide educational messages about maternal and newborn care, and (2) VHT members equipped with mobile phones to make unlimited phone call consultations with professional health workers for further clarification and advice Control arm: women in control group had access to group education that was routinely offered by health centres. The control group did not receive follow‐up visits by VHTs, and VHTs in control groups did not receive mobile devices |
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| Outcomes | Primary outcomes: health facility delivery (compared to home delivery) Secondary outcomes: antenatal consultations, birth preparedness, newborn care practices (cord care, thermal care, initiation of exclusive breastfeeding, care‐seeking for newborn illness) |
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| Notes | The funding agency (Directorate General for Development Cooperation of Belgium) had no role in study design, data management, or manuscript writing | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "random allocation was conducted by writing the names of HCs, VHTs or villages on small pieces of papers which were then folded to conceal the names. Two persons, each representing a study arm, but not associated to the study were asked to randomly pick folded papers from the pool of names. The process was repeated until allocation was completed for HCs, villages and VHTs" Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "random allocation was conducted by writing the names of HCs, VHTs or villages on small pieces of papers which were then folded to conceal the names" Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "blinding was not necessary since randomisation was at the level of Health Centres" Comment: blinding was not possible due to the nature of the intervention. Probably no |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to make any judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: attrition was 11.2% in the intervention arm and 9.7% in the control arm Reasons for attrition were similar across the 2 arms |
| 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 | High risk | Quote: "the control arm had four HCs of level II and four HCs of level III. The intervention arm had two HCs of level II and six HCs of level III. Therefore, pre‐intervention differences between control and intervention arms can be explained by variation in the distribution of HC levels in each arm"; "the difference in utilisation between HCs of level II and III explains why there were significantly more women recruited in HCs of level II among the control group compared to HCs of level II in the intervention group. The same argument can be extended to explain significant difference in antenatal care attendance in control arm compared to the intervention arm. These differences could have affected our results" Comment: probably not done |