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. 2020 Jul 15;2020(7):CD004945. doi: 10.1002/14651858.CD004945.pub5

Ocon 1997.

Study characteristics
Methods RCT (partially translated).
Participants Number of women randomised: 113
Setting: Gran Canaria, Spain
Study date: not reported
Inclusion criteria
  • Unknown due to not being fully translated

  • GA at intervention: 42 completed weeks


Exclusion criteria
  • Unknown, not in translation


State of cervix: unfavourable (Bishop score < 5)
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
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
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