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

Augensen 1987.

Methods RCT
Participants Number of women randomised: 409
 Setting: Bergen, Norway
Inclusion criteria
  • Healthy women

  • Normal pregnancy

  • Singleton

  • Cephalic presentation

  • Duration of pregnancy 290‐297 days from the first day of the LMP

  • Reliable dates

  • GA for intervention: 41+ weeks (290‐297 days)


Exclusion criteria
  • Use of contraceptive pills during the 2 months before the LMP


State of cervix: mixed (about 35% in each group had unripe cervix)
Interventions Induction group (n = 214): immediate induction with oxytocin (5 IU increased in a stepwise manner). GA at intervention 41+ weeks (290‐297 days)
versus
Expectant management group (n = 195): NST every 3‐4 days, IOL after 7 days
Outcomes Mother: caesarean section; assisted vaginal birth; length of labour; length of hospital stay
Baby: perinatal death; birthweight; neonatal jaundice; meconium‐stained amniotic fluid; NICU admission
Notes Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk List of random numbers
Allocation concealment (selection bias) Unclear risk Allocation concealment was unclear given that it was not undertaken by a staff member or team clearly uninvolved in the trial. It was reported that the midwife undertook allocation using a random number list, and this list was inaccessible to the participating physicians.
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 4/214 in the IOL group went into labour before IOL but data for these women have been included in the IOL group for analyses. No apparent losses to follow‐up or exclusions.
Selective reporting (reporting bias) High risk No outcomes were pre‐specified in the methods; some outcomes reported incompletely in text, e.g. "There was no significant difference between the groups in the use of analgesia, sedatives, and epidural anaesthesia."
Other bias Low risk Appears to be free of other bias