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

Heimstad 2007.

Study characteristics
Methods RCT
Participants Number of women randomised: 508
Setting: St. Olavs University Hospital, Trondheim, Norway
Study date: women randomised between September 2002 and July 2004
Inclusion criteria
  • Singleton pregnancies

  • GA: 41+ weeks (at intervention GA = 406 and beyond)

  • Cephalic presentation

  • No PROM

  • Primiparous (46%) and multiparous


State of cervix: all stages included
Interventions Inductiongroup (n = 254): if cervix favourable (Bishop score ≥ 6) AROM + oxytocin, if not (Bishop score < 6) 50 µg misoprostol vaginally
versus
EM group (n = 254): twice‐weekly ultrasound and CTG, labour induction after 300 days of pregnancy
Outcomes Mother: prolonged labour; mode of birth; perineal trauma; maternal satisfaction; postpartum haemorrhage
Baby: perinatal death; neonatal morbidity, for which a score was tallied (by evaluating the degree of deviation from the potential of a perfect outcome for each newborn as defined by the authors); neonatal trauma; birthweight; birthweight > 4000 g, NICU admission, birth asphyxia, meconium aspiration syndrome, Apgar < 7 at 5 minutes
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 Computerised randomisation using blocks of 16 with no stratification
Allocation concealment (selection bias) Low risk Central allocation ‐ clinical trials office
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 women were lost to follow‐up for clinical outcomes; 8 women did not complete the inclusion questionnaire; for the post‐birth telephone survey, 12 women were lost to follow‐up (4 in induction group and 8 in EM group).
Selective reporting (reporting bias) Unclear risk While all prespecified outcomes (in the methods) were reported, with no access to trial protocol, it was not possible to further assess selective reporting.
Other bias Low risk Appeared to be free of other bias