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

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.
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).
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.
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
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