Daniel‐Spiegel 2004.

Methods	Randomised controlled trial
Participants	Inclusion: induction of labour for post date pregnancy (> 42 weeks), ruptured membranes for more then 24 hours, oligohydramnios (amniotic fluid index < 5 cm), intrauterine growth restriction, diabetes, or a sporadic non‐reassuring fetal heart rate pattern. Exclusion: non‐vertex presentation, past history of more than 1 caesarean delivery, multiple pregnancies, non‐reassuring fetal heart rate before induction of labour and estimated fetal weight of more than 4250 g. Setting: Ha`Emek Medical Center, Afula, Israel from 1st February 1998 to 29th February 2000 (period of inclusion). Number of included participants: 104 women (52 continued and 52 discontinued group). The CONSORT flow diagram (fig 1) suggests that all 52 women allocated to the quote: "discontinue oxytocin in the active phase" group had oxytocin discontinued, despite all of them being recruited and randomised before 3 cm dilatation. There is no mention of any caesarean births before the active phase, nor of any rapid labour such that there was insufficient time to discontinue the oxytocin.
Interventions	Oxytocin No infusion Induction of labour was started by oxytocin infusion of 1 mIU/minute (5 IU of oxytocin was diluted in 500 mL of 0.9% NaCl). The dose was increased every 20 minutes by 1 mIU/minute until regular contractions at a rate of 3–5 per 10 minutes were reached. The maximal allowed dose of oxytocin was 20 mIU/minute. In group I, infusion of oxytocin was incremental until 5 cm dilatation, and was maintained at the same level until delivery. In group II, infusion of oxytocin was discontinued when cervical dilatation reached 5 cm.
Outcomes	Duration from induction to delivery Duration of the stages of labour Maximal dose and total amount of oxytocin used The use of analgesia Abnormalities in fetal heart rate Episodes of uterine hyperstimulation (more then 5 contractions in 10 minutes) Mode of delivery Maternal and neonatal outcomes
Notes	Discontinued group: 7.6% had oxytocin restarted due to lack of progression. Sources of trial funding: no information provided. Information on declaration of interest is absent from the trial report.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random number sequence.
Allocation concealment (selection bias)	Unclear risk	Sealed opaque envelopes were used. Not numbered. No record of missing envelopes. Quote: "The envelopes were opened before dividing the patients in two groups."
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding.
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No post‐randomisation exclusions. 200 assessed for eligibility. 96 did not meet inclusion criteria or refused participation. 104 were randomised.
Selective reporting (reporting bias)	High risk	No published protocol prior to article. The trial was unregistered. Apart from mode of delivery and birthweight, and a statement that quote: "no maternal or fetal complications were recorded", no maternal or fetal complications were reported.
Other bias	Unclear risk	Randomisation was performed when oxytocin was initiated at less than 3 cm. The Consort flow diagram implies that no caesarean births occurred before the active phase and that every woman who reached the active phase in the intervention group had time for the active phase to be diagnosed, for the oxytocin to be stopped and actually had the oxytocin stopped.