Niromanesh 2003.
Methods | Quote:"randomly assigned". | |
Participants | BS < 5, maternal age 20 to 30 years, gravidity 1 ‐ 3, parity 1 ‐ 2, < 6 contractions per hour, singleton pregnancy. Exclusion: history of preterm labour, antepartum bleeding, low‐lying placenta, history of caesarean deliveries, active herpes infection, acute poly or oligohydramnios, high blood pressure, IUFD, GA < 40 weeks, chronic condition or contraindication for use of PGs. |
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Interventions | Foley catheter 30 mL max 8 hours (n = 45). (PGE2) tablet 6‐hourly, max 6 doses (n = 44). |
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Outcomes | Primary: BS (after ripening). Secondary: ripening time, induction time, total time, delivery route, uterine hyperstimulation, adverse side effects, non‐reassuring FHR tracing, AS. |
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Notes | No sample size calculation. 1 patient withdrew due to 'complications'. Time of ripening in Foley group 8 hours, PG group 12 hours Setting: Mirza Kochkhan Hospital, Tehran, Iran. Study period: March 2000 to May 2001 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 | Random number table. |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelope. |
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 | No mention of incomplete data, insufficient information to permit judgment. |
Selective reporting (reporting bias) | Unclear risk | 1 patient was withdrawn due to 'complications', data for this patient not reported, other than this, data reported for all patients on the prespecified outcomes. |
Other bias | Low risk | No other bias detected |