Induction of labour using prostaglandin E2 as an inpatient versus balloon catheter as an outpatient: a multicentre randomised controlled trial

• Published in: BJOG : an international journal of obstetrics and gynaecology 2020-04, Vol.127 (5), p.571-579
• Main Authors: Beckmann, M, Gibbons, K, Flenady, V, Kumar, S
• Format: Article
• Language: English
• Subjects: Antibiotics; Balloon; Balloon catheters; Balloon treatment; Birth; Catheters; cervical ripening; Encephalopathy; Health risk assessment; Hypoxia; induced; Induced labor; Intubation; labour; mechanical methods; Neonates; outpatient; prostaglandin; Prostaglandin E2; Statistical analysis; Vagina
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1111/1471-0528.16030

Objective To compare clinical outcomes following induction of labour (IOL) using a balloon catheter and going home, versus prostaglandin (PG) as an inpatient. Design Randomised controlled trial. Setting Eight Australian maternity hospitals. Population Women with uncomplicated term singleton pregnancies undergoing IOL for low‐risk indications including post‐term, advanced maternal age and ‘social’ reasons. Methods Between September 2015 and October 2018, 347 women were randomised to a balloon outpatient group and 348 to a PG inpatient group. The PG group received Dinoprostone, either 2 mg gel or 10 mg controlled‐release tape. The balloon group had a double‐balloon catheter inserted and went home. Main outcome measures The primary outcome was a composite neonatal measure comprising nursery admission, intubation/cardiac compressions, acidaemia, hypoxic ischaemic encephalopathy, seizure, infection, pulmonary hypertension, stillbirth or death. Clinical and process outcomes are reported. Results There were no statistically significant differences in the primary outcome comparing balloon with PG (18.6% versus 25.8%; relative risk = 0.77, 95% CI 0.51–1.02; P = 0.070), cord arterial pH