Ocon 1997.
Study characteristics | ||
Methods | RCT (partially translated). | |
Participants | Number of women randomised: 113
Setting: Gran Canaria, Spain Study date: not reported Inclusion criteria
Exclusion criteria
State of cervix: unfavourable (Bishop score < 5) |
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Interventions |
Induction group (n = 57): intracervical PGE2 gel (0.5 mg); unclear whether further intervention occurred (full translation not available) versus EM group (n = 56): monitoring by NST, biophysical profile and amnioscopy |
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Outcomes | Mother: time to birth; mode of birth Baby: meconium staining; NICU admission; birthweight > 4000 g; Apgar score < 7 at 5 minutes (other outcomes may have been present, but were not reported in the translation) | |
Notes |
Funding: not reported Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generation was not reported according to the translation. |
Allocation concealment (selection bias) | Unclear risk | The method of allocation concealment was not reported according to the translation. |
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 | Low risk | No apparent losses to follow‐up or exclusions |
Selective reporting (reporting bias) | Unclear risk | No access to trial protocol to confidently assess selective reporting. Perinatal deaths appeared not to have been reported according to the translation, although this has not been verified by a second translation. |
Other bias | Low risk | Appeared to be free of other bias |