Stenlund 1999.
Methods | RCT, 2 arm trial. | |
Participants | Setting: 36 women attending hospital in Stockholm, Sweden. Inclusion criteria: maternal or fetal indications for labour induction, women in whom labour induction could be deferred for 48 h, Bishop score < 6, single pregnancy, head presentation and intact membranes. All women were 14 days post‐term and scheduled for induction, but where IOL could be postponed for 48 h. Exclusion criteria: parity > 4, contra‐indications to vaginal birth, oligohydramnios, prior uterine surgery, obstetric or medical complications. |
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Interventions | Intervention group: 400 mg mifepristone. Comparison group: placebo. Women returned for review after 24 h and 48 h if labour did not start. If Bishop score > 6 then ARM and oxytocin induction, if < 6 then PGE₂ 0.5 mg intracervical up to 2 treatments. |
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Outcomes | Labour within 48 h, Mode of onset of labour, ripe cervix within 48 h, birth within 48 h, need for PGE₂ for cervical ripening, change in Bishop score, duration of labour, interval from treatment to admission in labour, Apgar score, umbilical pH, maternal and neonatal serum concentrations of mifepristone at birth. |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random number tables. |
Allocation concealment (selection bias) | Low risk | Coded drug boxes, "sealed pre‐numbered boxes containing either mifepristone or placebo tablets". |
Blinding (performance bias and detection bias) Women | Low risk | "...the type of treatment the women were given was not known until the entire study was finished". |
Blinding (performance bias and detection bias) Clinical staff | Low risk | Study described as blinded. |
Blinding (performance bias and detection bias) Outcome assessor | Low risk | Study described as blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow up apparent. |
Selective reporting (reporting bias) | Unclear risk | Many more outcomes reported than mentioned in methods text. FHR and uterine contractility not mentioned specifically in results text. |
Other bias | Unclear risk | Some baseline imbalance, intervention group 79% primiparous versus 58% in the control group. |