Postpartum readmission for maternal infection or neonatal adverse events in women randomised to outpatient balloon versus inpatient prostaglandin for induction of labour: a post-trial follow up study

Induction of labour is common, and much has been studied about different methods and clinical outcomes for mothers and babies. However, many trials follow outcomes only until hospital discharge. The recently published OBLIGE multicentre randomised controlled trial of 1087 participants found no differences in adverse events for mothers or their babies in groups randomised at term to outpatient balloon catheter versus inpatient vaginal prostaglandin E2. The aim of this analysis was to evaluate maternal and neonatal readmissions from hospital discharge to six weeks after birth. A post-trial follow up of the OBLIGE trial. The clinical records of a subset of participants for whom notes were accessible were reviewed (564 mothers and 477 babies). The primary outcome was maternal readmission to hospital up to six weeks after birth (including a hospital visit of 3 h or more) for infection requiring antibiotics. The secondary outcome was neonatal readmission to hospital up to six weeks after birth (including a hospital visit of 3 h or more) for any reason. Of women randomised to outpatient balloon, 6.3% were readmitted with an infection compared to 6.5% in the inpatient prostaglandin group (p = 0.99). Of babies born to mothers randomised to outpatient balloon, 10.2% were readmitted compared to 11.7% in the inpatient prostaglandin group (p = 0.59). In this subset of participants in the OBLIGE trial, there were no differences in maternal readmission for infection, or neonatal admission for any reason, up to six weeks after birth. Consideration of readmission risk for mothers and babies after outpatient balloon induction of labour does not seem to be a reason not to routinely offer outpatient balloon induction of labour. The OBLIGE trial was registered with the Australia New Zealand Clinical Trials Registry (ANZCTR) on 06/06/2016 (ACTRN: 12,616,000,739,415). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370330&isReview=true