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

Abstract

BackgroundThe aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the out-patient setting.MethodsAn open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥16 years, undergoing Induction of labour (IoL) at term, with intact membranes and deemed suitable for out-patient IoL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal Dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Health economics data were collected. Women who declined to participate were also requested to complete a decliners’ questionnaire.ResultsDuring the study period 274 eligible women were identified. 230 (83.9%) were approached for participation of whom 84 (36.5%) agreed. Of these, 38 were randomised to Propess (n=20) and CRB (n=18). The intended sample size of 120 was not reached due to restrictive criteria for suitability for out-patient IoL. The intervention as randomised was received by 29/38 (76%) women. Five of the 29 participants could not go home after intervention. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the Dinoprostone group, and 11/18 (61%) women 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.Full health economics data were available for 36 out of the 38 participants. 21% of women in the Dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group. The patient questionnaire was complete and available for analysis for 37/38 (97.4%) women. Interviews were undertaken for 21/38 women.ConclusionsA third of the approached eligible women agreed for randomisation. An RCT is not feasible using existing criteria and further modifications to the eligibility criteria for out-patient IoL would be needed to reach sufficient numbers in the current service context.

Mechanical methods for induction of labour

“…We included 60 new trials (120 reports), added two trial reports to already included studies and excluded 74 trials (102 reports). Two trials from the January 2018 search are awaiting classification (Agboghoroma 2015; Mallah 2011), and 21 are ongoing (Argilagos 2016; Beckmann 2013; Bekele 2017; Berndl 2016; Bhide 2017; Eser 2016; Goli 2017; Goonewardene 2016; Gupta 2016; Hassanzadeh 2017; Igwe 2017; Lacarin 2017; Lauterbach 2017; Levy 2016; Osoti 2016; Park 2012; Perrotin 2016; Tagore 2015; Viteri 2015; Wise 2016; Yildirim 2017).…”