Sharami 2005.
Study characteristics | ||
Methods | Randomised trial: computer‐generated random number table, blocks of 4, sequentially‐numbered opaque sealed envelopes. | |
Participants | Nulliparous women, admitted for induction, between 34 and 42 weeks GA, singleton in cephalic presentation, BS < 4, intact membranes, reassuring FHR tracing, < 6 contractions per hour Exclusion: significant vaginal bleeding, fetal chorioamnionitis, any contraindication to vaginal delivery, previous uterine scar, FHR abnormalities, severe pre‐eclampsia, contraindication to PG. |
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Interventions | Foley 30 mL + EASI + concurrent IV oxytocin for 12 hours (n = 76). PGE2 gel 0.5 mg intracervical 6‐hourly, max 3 doses (n = 75). |
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Outcomes | Interval from start induction to active phase, abnormal FHR tracing, tachysystole, hyperstimulation, meconium passage, caesarean delivery, chorioamnionitis, endometritis, AS < 7, admission NICU Secondary: start induction to delivery, change in dilation at 1, 6, 12 hours, CS for failed induction. |
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Notes | No sample size calculation. Prophylactic antibiotics after 12 hours of start induction Setting: Prenatal Clinic in Al‐Zahra Maternity Hospital, Iran Dates of study: March 2002 ‐ September 2003 Funding sources: 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 | Computer‐generated sequence. |
Allocation concealment (selection bias) | Low risk | Sequentially‐numbered opaque sealed 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 | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Good description of excluded patients, quite evenly spread over the groups. There is no information about missing/incomplete outcome data. |
Selective reporting (reporting bias) | Low risk | It seems that all outcomes prespecified in methods were reported, report includes all expected outcomes. |
Other bias | Low risk | No other bias detected |