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. 2020 Jul 15;2020(7):CD004945. doi: 10.1002/14651858.CD004945.pub5

Egarter 1989.

Study characteristics
Methods RCT
Participants Number of women randomised: 345
Setting: Vienna, Austria
Study date: not reported
Inclusion criteria
  • Length of pregnancy established by early ultrasound

  • Membranes intact

  • Cervix favourable for induction (modified Bishop score of > 4)

  • GA at intervention: 40 completed weeks ("at due date")

  • Approximately half the women were primiparous


Exclusion criteria
  • Any fetal or maternal risk factors based on history, gynaecological/obstetrical investigation, CTG and routine lab results


State of cervix: favourable (Modified Bishop score > 4)
Interventions Induction group (n = 180): vaginal PE2 (3 mg) tablets repeated 6 and 24 hours later if no active labour
versus
EM group (n = 165): spontaneous labour awaited until 42 weeks. NST monitoring every 2‐3 days
Outcomes Mother: birth interval (onset of contractions to birth in hours); rate and indication for operative birth; length of labour; analgesia requirements; caesarean section
Baby: birthweight; length of baby at birth; incidence of meconium‐stained amniotic fluid; Apgar scores; results of umbilical cord pH determination; perinatal death
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 The method of allocation concealment was not reported.
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 Unclear risk 8/180 women in the induction group refused to be induced; and 3/165 women in the expectant group requested induction; and these 11 women were excluded from analysis post‐randomisation.
Selective reporting (reporting bias) High risk No outcomes were prespecified in the methods, limited information was provided for some outcomes, e.g. "The incidence of prolonged labor was not different in both groups... both groups required analgesic treatment in 35%... Birthweight and length, the incidence of meconium‐stained amniotic fluid, of low Apgar scores, and the results of pH determination were not different between the two groups."
Other bias Unclear risk Some imbalance in the numbers randomised to each group (180 versus 165)