Bagratee 1990.
Methods | RCT. Random number tables, stratified for parity. No details were given on the method for concealment of the allocation. | |
Participants | Women with unfavourable cervix (BS < 7). | |
Interventions | Lamicel (40 women); (PGE2) (2 mg tablet) (40 women). After 6 hours, oxytocin was started in both groups. | |
Outcomes | CS, hyperstimulation, fetal distress, perinatal death. | |
Notes | No outcome reported in subgroups. setting: king Edward VIII hospital, Durban, South Africa Study period: for 6 months, no exact dates reported Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number tables |
Allocation concealment (selection bias) | Unclear risk | Unclear, not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not feasible due to nature of intervention |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | No ITT mentioned, in table 4 cases missing, not clear why. |
Selective reporting (reporting bias) | Low risk | All pre‐specified outcomes reported |
Other bias | Low risk | No other bias detected |