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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. Health economics data were collected. Women who declined to participate were also 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 (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.
Conclusions
A 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.
Keywords
Labour, induced, Cervical ripening, Randomised controlled trial, Cook cervical ripening balloon, Outpatients, feasibility
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Peer Review Timeline
CURRENT STATUS: Published
View the published article at Pilot and Feasibility Studies.
No community comments so far
Editorial decision: Accept
On 31 Jul, 2020
Reviewers invited
Invitations sent on 15 Jun, 2020
Reviewer #1 agreed
On 15 Jun, 2020
Review #1 received
Received 15 Jun, 2020
Editor assigned
On 12 Jun, 2020
Submission checks complete
On 11 Jun, 2020
Editor invited
On 11 Jun, 2020
Version 1
Posted 20 Feb, 2020
No comments provided
Editorial decision: Major revision
On 08 May, 2020
Review #2 received
Received 06 May, 2020
Reviewer #2 agreed
On 23 Apr, 2020
Review #1 received
Received 01 Apr, 2020
Reviewers invited
Invitations sent on 16 Mar, 2020
Reviewer #1 agreed
On 16 Mar, 2020
Editor assigned
On 18 Feb, 2020
Submission checks complete
On 17 Feb, 2020
Editor invited
On 17 Feb, 2020
First submitted
On 07 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Sexual & Reproductive Medicine
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Pilot and Feasibility Studies.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Pilot and Feasibility Studies.
No community comments so far
Editorial decision: Accept
On 31 Jul, 2020
Reviewers invited
Invitations sent on 15 Jun, 2020
Reviewer #1 agreed
On 15 Jun, 2020
Review #1 received
Received 15 Jun, 2020
Editor assigned
On 12 Jun, 2020
Submission checks complete
On 11 Jun, 2020
Editor invited
On 11 Jun, 2020
Version 1
Posted 20 Feb, 2020
No comments provided
Editorial decision: Major revision
On 08 May, 2020
Review #2 received
Received 06 May, 2020
Reviewer #2 agreed
On 23 Apr, 2020
Review #1 received
Received 01 Apr, 2020
Reviewers invited
Invitations sent on 16 Mar, 2020
Reviewer #1 agreed
On 16 Mar, 2020
Editor assigned
On 18 Feb, 2020
Submission checks complete
On 17 Feb, 2020
Editor invited
On 17 Feb, 2020
First submitted
On 07 Feb, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Sexual & Reproductive Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Pilot and Feasibility Studies.
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. Health economics data were collected. Women who declined to participate were also 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 (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.
Conclusions
A 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.
Figure 1
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