Sande 1983.
Study characteristics | ||
Methods | RCT | |
Participants | Number of women randomised: 166
Setting: Ulleval Hospital, Norway Study date: not reported Inclusion criteria
Exclusion criteria
State of cervix: Bishop score ≥ 5 |
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Interventions |
Induction group (n = 76): IOL on the following morning after randomisation; IV oxytocin (10 units in 1 L 5% glucose) immediately following AROM. Women were monitored by CTG versus EM group (n = 90): waited for spontaneous labour to occur, following the normal procedure for the department (labour was induced after 42 weeks) |
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Outcomes |
Mother: duration of first and second stages of labour; pain relief; mode of birth (caesarean birth; vacuum; forceps; spontaneous birth); postpartum bleeding; induction to birth interval Baby: liveborn; neonatal death; birthweight; Apgar scores at 1 and 5 minutes; morbidity (transfer to NICU; paediatric examination of 1st and 5th day) |
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Notes | Only data for perinatal death, stillbirth and neonatal death included in meta‐analyses | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The method of sequence generated 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 | High risk | Per protocol analysis performed. Of the 76 women randomised to the induction group, 23 birthed spontaneously before induction In the EM group, 15 of the 90 women passed 42 weeks and had their labour induced. Therefore, there were a total of 68 women who had their labour induced, and 98 birthed spontaneously (results analysed as such, not as per randomisation). |
Selective reporting (reporting bias) | High risk | A number of outcomes such as birthweight, postpartum bleeding, and neonatal morbidity were reported incompletely in the text, e.g. “no differences” and “ns.” |
Other bias | Unclear risk | No information by randomisation group |