Cole 1975.
Study characteristics | ||
Methods | Randomly allocated, no further details available | |
Participants | Number of women randomised: 228
Setting: Glasgow, Scotland Study date: not reported Inclusion criteria
State of cervix: not reported |
|
Interventions |
Induction group (n = 111): IOL with AROM + oxytocin
versus EM group (n = 117): no intervention until 41 weeks, thereafter IOL |
|
Outcomes |
Mother: length of labour; mode of birth (including operative versus non operative); analgesia requirements; postpartum blood loss Baby: perinatal deaths; meconium staining; Apgar scores; birthweight; neonatal jaundice |
|
Notes |
Funding: not reported Declarations of interest: not reported |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generation was not reported. |
Allocation concealment (selection bias) | Unclear risk | The method of allocation concealment was not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not feasible. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinded outcome assessment was not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 7/118 and 2/119 in the intervention and control groups excluded after randomisation because of misclassification as low risk |
Selective reporting (reporting bias) | Unclear risk | No outcomes were prespecified in the methods; no access to trial protocol to further assess selective reporting |
Other bias | Low risk | Appeared to be free of other bias |