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. 2017 Sep 13;2017(9):CD007701. doi: 10.1002/14651858.CD007701.pub3

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.
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.
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.