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. 2023 Mar 30;2023(3):CD001233. doi: 10.1002/14651858.CD001233.pub4

Gelisen 2005.

Study characteristics
Methods RCT, randomisation by sealed opaque envelopes, no mentioning of sequence.
Participants Singleton live pregnancy, GA 41 completed weeks, BS < 5, no contractions, AFI > 5, estimated fetal body weight < 4500 g.
Exclusion: known hypersensitivity to PG, previous caesarean delivery or other uterine surgery, MBI > 30, parity > 4, low‐lying placenta.
Interventions Foley catheter 50 mL (n = 100).
Vaginal misoprostol 50 mcg 6‐hourly, max 24 hours (n = 100). (group excluded because of high dose)
Oxytocin low dose protocol (n = 100).
Spontaneous follow‐up (n = 300). (not in analyses)
Outcomes CS rate, neonatal outcomes: meconium, arterial pH, acidaemia, admissions to NICU
secondary, tachysystole, hyperstimulation, fetal distress.
Notes Primary goals of study is to compare induction versus expectant management.
Setting: tertiary training centre in Turkey
Study period: not 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 600 opaque envelopes, 1 was drawn every time.
Allocation concealment (selection bias) Low risk Opaque envelopes.
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 Low risk Blinded assessment of fetal monitor strips. (to assess hyperstimulation).
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Not addressed, seems like all data complete.
Selective reporting (reporting bias) Low risk All pre‐specified outcome measures are reported.
Other bias Low risk No other bias detected