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

Gelisen 2005.

Methods RCT
Participants Number of women randomised: 600
 Setting: teaching hospital in Ankara, Turkey; recruitment dates not reported
Inclusion criteria
  • Singleton pregnancy

  • Vertex presentation

  • Intact membranes

  • Bishop score of < 5

  • Absence of spontaneous uterine contractions (< 4 per hour)

  • Estimated fetal body weight < 4500 g

  • Reactive NST

  • Amniotic fluid index ≥ 5 cm

  • GA at intervention: 41 completed weeks (287 days +/‐ 1 day)


Exclusion criteria
  • Allergic to prostaglandins

  • Previous caesarean section

  • Non‐cephalic presentation

  • Body mass index 30 or more before conception

  • Parity 5 or more

  • Low‐lying placenta

  • Previous labour induction attempt


State of cervix: unfavourable ‐ Bishop score < 5
Just under half the women were nulliparous.
Interventions Induction group: labour induction (3 methods*)
(1) vaginal administration of 50 mg misoprostol (n = 100)
(2) oxytocin induction (n = 100), and
(3) transcervical insertion of a Foley balloon (n = 100)
versus
Expectant management group: spontaneous follow‐up with twice‐weekly nonstress testing and amniotic fluid measurement and once‐weekly biophysical scoring (n = 300); 24% of women were induced after 42 completed weeks.
*the 3 induction arms were combined for analyses
Outcomes Mother: oligohydramnios; pre‐eclampsia; tachysystole; hyperstimulation; vaginal birth; caesarean (emergent abdominal birth for worrying FHR); failed IOL
 Baby: perinatal death; shoulder dystocia; meconium stained amniotic fluid; meconium aspiration syndrome; fetal anomaly; low Apgar scores (< 7 at 5 mins); umbilical artery pH < 7.16; NICU admission; fetal macrosomia; birthweight; birthweight > 4000 g; length of hospital stay
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 concealment was by sealed, opaque envelopes but there is no mention of numbering and sequential opening of the envelopes.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding: "Staff members in charge of labor were not blinded to the type of medication used for induction".
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Blinded outcome assessment not mentioned.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No apparent losses to follow‐up or exclusions.
Selective reporting (reporting bias) Unclear risk While pre‐specified outcomes (in the methods) were reported, no access to trial protocol to further assess selective reporting.
Other bias Low risk Appears to be free of other bias.