Newman 1997.
Methods | RCT, 2 arm trial. | |
Participants | 58 women. South Carolina, USA. Inclusion criteria: women with diabetes at term or women with prolonged pregnancy (> 42 weeks) requiring induction, Bishop score < 7. |
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Interventions | Intervention group: 2 mg intravaginal PGE₂ after reassuring NST, then continuous fetal monitoring for 3 h. Women were admitted if labour started or cervix favourable. Treatment repeated after 24 h and 48 h and admitted after third dose. Comparison group: expectant management with weekly assessment of AFI and NST. Admission in labour or if signs of fetal distress. IOL at 44 weeks. |
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Outcomes | Spontaneous labour within 48 h, uterine hyperstimulation, CS. | |
Notes | Results reported in brief abstract. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as "prospectively randomised". |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) Women | High risk | Not feasible. |
Blinding (performance bias and detection bias) Clinical staff | High risk | Not feasible. |
Blinding (performance bias and detection bias) Outcome assessor | Unclear risk | Outcomes assessors not mentioned in brief abstract. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Little information. No loss to follow up apparent. |
Selective reporting (reporting bias) | Unclear risk | Trial reported only in brief abstract so unable to assess this bias domain. |
Other bias | Unclear risk | Trial reported only in brief abstract so unable to assess this bias domain. |