A comparison of inpatient with outpatient balloon catheter cervical ripening: a pilot randomized controlled trial

BACKGROUND One in four Australian births are induced. If cervical ripening using a prostaglandin is required, a pre-labour overnight hospitalisation and separation from family and support companions is necessary. Recent evidence shows that balloon catheter cervical ripening is just as effective as prostaglandins, but does not cause uterine stimulation. For women with low risk pregnancies, this offers the possibility of undergoing the overnight ripening process in their own home. We conducted a pilot randomised trial to assess the outcomes, clinical pathways and acceptability to both women and clinicians of outpatient balloon catheter ripening compared with usual inpatient care. METHODS Forty-eight women with low risk term pregnancies were randomised (2:1) to either outpatient (n = 33) or inpatient double-balloon catheter (n = 15) cervical ripening. Although not powered for statistically significant differences, the study explored potential direction of effect for key clinical outcomes such as oxytocin use, caesarean section and morbidities. Feedback on acceptability was sought from women at catheter insertion and 4 weeks after the birth, and from midwives and doctors, at the end of the study. RESULTS Clinical and perinatal outcomes were similar. Most women required oxytocin (77 %). The outpatient group were 24 % less likely to require oxytocin (risk difference -23.6 %, 95 % CI -43.8 to -3.5). There were no failed inductions, infections or uterine hyperstimulation attributable to the catheter in either group. Most women in both groups reported discomfort with insertion and wearing the catheter, but were equally satisfied with their care and felt the baby was safe (91 % both groups). Outpatient women reported feeling less isolated or emotionally alone. Most midwives and doctors (n = 90) agreed that they are more comfortable in sending home a woman with a catheter than prostaglandins and 90 % supported offering outpatient ripening to eligible women. CONCLUSIONS Outpatient balloon catheter ripening should be further investigated as an option for women in an adequately powered randomised trial. TRIAL REGISTRATION Prospectively registered, Australian New Zealand Clinical Trials Registry ACTRN12612001184864 .