Labour induction with low dose PGE2 vaginal gel: result of an Australian multicentre randomized trial.

An open-label, parallel, randomized study was conducted in 6 Australian hospitals involving 320 women near term who required induction of labour. Labour induction with 1 or 2mg of PGE2 in a vaginal triacetin gel repeated if necessary at 6 hours was compared to induction by amniotomy and intravenous oxytocin. Analysis of the 2 groups confirmed matching with regards demographic and clinical data. A significantly longer and more variable mean induction to onset of established labour interval was recorded in the PGE2 group (6.7 +/- 4.8 versus 2.0 +/- 1.1 hours. (p less than 0.001). The mean period of established labour was also longer (8.1 versus 6.0 hours, p less than 0.001) in the PGE2 group. However, 48% of PGE2 treated patients versus 29% oxytocin treated patients (p less than 0.01) were recorded as not experiencing strong contractions. Twelve hours after induction 65% of the PGE2 group and 93% of the oxytocin group were in established labour; 24% of the PGE2 treated group required subsequent augmentation with oxytocin. Spontaneous delivery occurred in 69% of PGE2 treated women and 62% of those treated with oxytocin (N.S.). Analgesic requirements were not statistically different between the groups. Fewer fetal heart rate abnormalities were recorded in the PGE2 treated group (p less than 0.02). No serious and only minimal adverse events were recorded in either treatment group.

RCT Entities:   Population Interventions Outcomes