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

Nielsen 2005.

Methods RCT
Participants Number of women randomised: 226
 Setting: Army Medical Center, Tacoma, Washington, USA
Inclusion criteria
  • GA at intervention: 39‐40 weeks

  • Cephalic presentation

  • Singleton gestation

  • Maternal age of greater than 17 years

  • Candidate for vaginal birth

  • Semi‐favourable cervical Bishop score defined as a score of 5 or greater in nulliparous or 4 or greater in multiparous women


Exclusion criteria
  • No additional criteria reported


State of cervix: favourable (≥ 5 for nulliparous and ≥ 4 for multiparous women)
Interventions Induction group (n = 116): AROM, oxytocin or both
versus
Expectant management group (n = 110): weekly follow‐up until 42 weeks. Labour induced after 42 weeks. Weekly monitoring with CTG and ultrasound, increased to twice a week after 41 weeks.
Outcomes Mother: randomisation to birth interval; admission to birth interval; Indication for admission; epidural analgesia; mode of birth; EBL; length of labour; chorioamnionitis; postpartum days
Baby: birthweight; admission to NICU; Apgar score < 7 at 5 mins
Notes The study was discontinued after recruitment of 226 women (target of 600) due to slow recruitment and no observed difference in the 2 groups
Funding: not reported
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The randomisation sequence was generated using a computer‐generated list.
Allocation concealment (selection bias) Low risk Allocation concealment was achieved using sequentially numbered, opaque, sealed 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. 23/116 (19.8%) in induction group went into spontaneous labour, 10/110 (9.1%) in the expectant management group required labour induction and results for these women were analysed according to which group they were randomised.
Selective reporting (reporting bias) Unclear risk No access to trial protocol for confidently assess selective reporting. Perinatal death not reported.
Other bias Unclear risk Baseline imbalance for Bishop score "The only significant difference noted was EM patients had a more favorable Bishop score on admission than IND patients (7.2+2.1 versus 8.6+2.0, p<0.0001)."