| Methods |
Cluster‐randomised trial with clinic as the unit of randomisation. |
| Participants |
15,994 low‐risk women at 7 clinics. |
| Interventions |
Reduced visits: 6 visits, all goal‐oriented which directed the provider towards a certain purpose.
Standard ANC: 14 visits , but before the trial standard care was 7. |
| Outcomes |
Women: maternal death, maternal morbidity, emergency caesarean section, referral patterns during antenatal period and during labour, obstetric intervention.
Babies: perinatal death, preterm birth (< 37weeks), low birthweight (< 2500 g), small‐for‐gestational age (SGA). |
| Notes |
Number of visits achieved: reduced visits group 4, and standard ANC 6. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described. |
| Allocation concealment (selection bias) |
Low risk |
Concealment of allocation: sequentially numbered envelopes containing either of the programme types. |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Blinding not feasible with this type of intervention. This was a cluster trial. Staff in intervention clinics received special training and would be aware of treatment allocation. Content of visits was specified. |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Outcomes were recorded in case notes completed by staff aware of allocation. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Loss to follow‐up: 462/15,994 (2.9%) of participants. |
| Selective reporting (reporting bias) |
Unclear risk |
It was stated that there was more referral for pre‐eclampsia in the group receiving more visits. This may be due to increased opportunities for detection and reporting in this group. All relevant outcomes appeared to have been reported. |
| Other bias |
Low risk |
Other bias not apparent. |
