Prostaglandin insert Dinoprostone versus trans-cervical balloon catheter for out-patient labour induction: A randomised controlled trial of feasibility (PROBIT-F)
Background The 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.
Methods An 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. 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 decliners’ 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 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 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.
Figure 1
Posted 15 Jun, 2020
On 15 Aug, 2020
On 31 Jul, 2020
Invitations sent on 15 Jun, 2020
On 15 Jun, 2020
Received 15 Jun, 2020
On 12 Jun, 2020
On 11 Jun, 2020
On 11 Jun, 2020
On 08 May, 2020
Received 06 May, 2020
On 23 Apr, 2020
Received 01 Apr, 2020
Invitations sent on 16 Mar, 2020
On 16 Mar, 2020
On 18 Feb, 2020
On 17 Feb, 2020
On 17 Feb, 2020
On 07 Feb, 2020
Prostaglandin insert Dinoprostone versus trans-cervical balloon catheter for out-patient labour induction: A randomised controlled trial of feasibility (PROBIT-F)
Posted 15 Jun, 2020
On 15 Aug, 2020
On 31 Jul, 2020
Invitations sent on 15 Jun, 2020
On 15 Jun, 2020
Received 15 Jun, 2020
On 12 Jun, 2020
On 11 Jun, 2020
On 11 Jun, 2020
On 08 May, 2020
Received 06 May, 2020
On 23 Apr, 2020
Received 01 Apr, 2020
Invitations sent on 16 Mar, 2020
On 16 Mar, 2020
On 18 Feb, 2020
On 17 Feb, 2020
On 17 Feb, 2020
On 07 Feb, 2020
Background The 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.
Methods An 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. 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 decliners’ 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 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 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.
Figure 1