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. 2018 May 9;2018(5):CD004945. doi: 10.1002/14651858.CD004945.pub4

Roach 1997.

Methods RCT
Participants Number of women randomised: 201
 Setting: Hong Kong, China
Inclusion criteria
  • GA at intervention: 42 completed weeks


Exclusion criteria
  • Pre‐eclampsia

  • Gestational diabetes

  • Contraindication to vaginal birth (e.g. placenta praevia, non‐cephalic presentation)

  • Evidence of fetal or maternal compromise


State of cervix: not mentioned as a criterion
Interventions Induction group (n = 96): PGE2 pessaries 6‐hourly if necessary
versus
 Expectant management group (n = 105): serial monitoring with NST (x2) and amniotic fluid index measurements (x1) weekly.
Outcomes Mother: spontaneous labour; caesarean section; fetal distress in labour
Baby: birthweight; Apgar score < 7 (1 min/5 min); cord blood pH; admission to NICU; meconium below the vocal cords
Notes Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The method of sequence generation was not reported.
Allocation concealment (selection bias) Unclear risk Allocation in a series of identical envelopes but no mention of sealed envelopes, opaqueness and sequential numbered envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Blinding was not feasible.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinded outcome assessment was not mentioned.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No apparent losses to follow‐up or exclusions. 17/96 (18%) in the induction group went into spontaneous labour and 12/105 (11%) in the expectant management group were induced and the results for these women were included in the analyses.
Selective reporting (reporting bias) Unclear risk Very few outcomes reported; "We did not address perinatal mortality in this study." No access to trial protocol to further assess selective reporting.
Other bias Low risk Appears to be free of other bias.