Prostaglandin insert Dinoprostone versus trans-cervical balloon catheter for out-patient labour induction: A randomised controlled trial of feasibility (PROBIT-F)

Amarnath Bhide, Philip Sedgwick, Barbara Barrett, Georgina Crupples, Rose Coates, Rosie Goode, Sandra Linton, Christine McCourt

Research output: Contribution to journalArticlepeer-review

Abstract

Background The aim was to assess the feasibility of conducting an open-label randomised controlled trial (RCT) of induction of labour (IoL) comparing use of two methods in the out-patient setting. Methods The feasibility study was conducted in two UK maternity units from October 2017 to March 2019. Women were eligible if aged ≥16, undergoing IOL at term, with intact membranes and deemed suitable for out-patient IOL according to local guidelines . They were randomised to cervical ripening balloon catheter (CRB) or vaginal Dinoprostone (Propess).. Service use and cost data were collected via the The Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a questionnaire. Results During the study period 274 eligible women were identified; 230 (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not .. . Of these, 38 were randomised to Propess (n=20) and CRB (n=18). Decliner data were collected for 93 women. The reasons for declining were declining IOL (n = 22), preference for in-patient IOL (n = 22) and preference for a specific method, propess (n = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for out-patient IOL, participant preference for propess and shortage of research staff. The intervention as randomised was received by 29/38 (76%) women. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the propess group, and 11/18 (61%) in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition (5-minute Apgar score >7), and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. -21% of women in the Dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group. Conclusions A third of the approached eligible women agreed for randomisation . An RCT is not feasible in the current service context. Modifications to the eligibility criteria for out-patient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers.
Original languageEnglish
JournalPilot and Feasibility Studies
Publication statusAccepted/In press - 31 Jul 2020

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