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. |
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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) |
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Outcomes | CS rate, neonatal outcomes: meconium, arterial pH, acidaemia, admissions to NICU secondary, tachysystole, hyperstimulation, fetal distress. |
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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 |
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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 |