Clinical Trial Results:
Prostaglandin insert (Propess) versus tran-scervical balloon catheter for out-patient labour induction: A randomised controlled trial of feasibility (PROBIT-F)
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Summary
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EudraCT number |
2017-001914-27 |
Trial protocol |
GB |
Global end of trial date |
31 Mar 2019
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Feb 2020
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First version publication date |
06 Feb 2020
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Other versions |
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Summary report(s) |
Protocol V3.0 Final Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
13.0029
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Additional study identifiers
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ISRCTN number |
ISRCTN03199820 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
St George’s Joint Research and Enterprise Services (JRES)
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Sponsor organisation address |
Jenner Wing, Ground Floor, Cranmer Terrace, London, United Kingdom, SW17 0RE
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Public contact |
St George’s Joint Research and Enterprise Services (JRES), St George’s Joint Research and Enterprise Services (JRES), 0044 20 8266 6397, sponsor@sgul.ac.uk
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Scientific contact |
St George’s Joint Research and Enterprise Services (JRES), St George’s Joint Research and Enterprise Services (JRES), 0044 20 8266 6397, sponsor@sgul.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Aug 2019
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Mar 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Mar 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
This is a feasibility study. The primary objective is to determine the feasibility of conducting a randomised controlled trial of Prostaglandin pessary versus trans-cervical balloon catheter for out-patient induction of labour.
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Protection of trial subjects |
The current study has shown that the options of induction of labour in the out-patient setting, and the use of mechanical methods for labour induction are acceptable to women. However, the current criteria for eligibility for out-patient IOL are restrictive, so that only a small minority of women undergoing IOL are found suitable for out-patient induction. The qualitative data from the current study shows that women were positive about CRB because it did not involve hormones and appeared a more gentle first IOL intervention. The vast majority of participants felt that going home would be beneficial to them.
A previously published study has shown that for women with an unfavourable cervix at term, success of induction of labour with a mechanical method is similar to induction of labour with progstaglandins, with fewer maternal and neonatal side-effects, but similar Caesarean section rates (Jozwiac, 2011). Pain scores are known to be lower in women using mechanical methods of labour induction in the in-patient setting (Pennell et al, 2009). The present study was not powered to explore differences in clinical outcomes, nor the safety of out-patient IoL. The intended sample size could not be reached due to restrictive local guidelines for out-patient induction of labour. The restrictions were made due to safety concerns about outpatient induction. To overcome this and provide the necessary safety data, a large observational study is necessary. Members of the current study team have been successful in securing funding for such an observational study (CHOICE study, NIHR127569). It is possible to make criteria for suitability of out-patient IoL more permissive if the safety of out-patient IoL is demonstrated with an observational study.
Comparison of clinical outcomes from outpatient with inpatient CRB treatment for low risk labour induction would be a useful study to assess the effect of the setting of IoL (out-patient versus in-patient).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 84
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Worldwide total number of subjects |
84
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EEA total number of subjects |
84
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
84
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Open to recruitment: 22/09/2017 Recruitment end date (Actual): 31/01/2019 | |||||||||||||||||||||
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Pre-assignment
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Screening details |
Inclusion: Pregnant women aged 18 years or over with a single fetus and uncomplicated pregnancy, who were at a Gestational age > 37 completed weeks, needing induction of labour. Exclusion: Unsuitable for outpatient management; Unsuitable for randomisation to either and pre-medical health conditions that condition safety | |||||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Cervical Ripening Balloon catheter | |||||||||||||||||||||
Arm description |
The second is a catheter - a soft rubber tube with an inflatable balloon at the tip. The balloon is placed in the cervix causing it to soften and release natural hormones (prostaglandins) produced by the woman's body. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Cervocal Ripening Balloon with Stylet
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Implant
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Routes of administration |
Vaginal use
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Dosage and administration details |
The Cook Cervical Ripening Balloon is a silicone double-balloon catheter with an adjustable-length malleable stylet.
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Arm title
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Propess | |||||||||||||||||||||
Arm description |
The method uses dinoprostone, a synthetic hormone administered as a pessary (Propess) introduced in the vagina that delivers prostaglandin over 24 hours | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Propess
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Vaginal suspension
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Routes of administration |
Vaginal use
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Dosage and administration details |
PROPESS 10mg vaginal delivery system
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Please, see the attached Final Study Report |
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
The rate of induction of labour (IoL) has increased steadily over the last decade. Out-patient IoL is considered feasible but there is insufficient evidence about women’s preference, or which intervention is the most effective and safe to use in outpatient settings. An open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Cervical Ripening Balloon catheter
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Reporting group description |
The second is a catheter - a soft rubber tube with an inflatable balloon at the tip. The balloon is placed in the cervix causing it to soften and release natural hormones (prostaglandins) produced by the woman's body. | ||
Reporting group title |
Propess
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Reporting group description |
The method uses dinoprostone, a synthetic hormone administered as a pessary (Propess) introduced in the vagina that delivers prostaglandin over 24 hours | ||
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End point title |
Last data entry point. [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
End of the study is defined as the last data entry point. (as describe on the Protocol)
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Please, see the attached Final Study Report |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
since the first recruited participants until the last day of follow up for the last recruited participant.
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
DAIDS | ||
Dictionary version |
unk
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Please, see the attached Final Study Report |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Nov 2017 |
SAM01_AM02
Adverts to promote study awareness to staff and potential participants |
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10 Jan 2018 |
SAM02_AM04
Eligibility criteria refined to reflect hospital policy for IOL and detail added regarding qualitative study to include audio recording of study invitation and clarity added over inclusion of birth partner to capture their experience |
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25 Jun 2018 |
SAM03_AM05
Change of study personnel – Sponsor Representative, TMG & TSC members.
Clarification on when potential participants can be provided study information.
Addition of Midwife interviews.
Addition of audio-recording of discussions/interviews.
Minor typographical errors corrected.
New Data Protection Act 2018 transparency information added to information sheets
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| In total, 84 (36.5%) women gave consent to participate. The remaining 40 women did not decline but did not give consent for various reasons. Overall, 38 of the 84 agreeing women were randomised for participation in the trial. | |||
