Gelisen 2005.
Methods | RCT | |
Participants | Number of women randomised: 600
Setting: teaching hospital in Ankara, Turkey; recruitment dates not reported Inclusion criteria
Exclusion criteria
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. |