Clinical Trial Results:
A feasibility study investigating pravastatin for the prevention of preterm birth in women
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Summary
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EudraCT number |
2017-005021-21 |
Trial protocol |
GB |
Global end of trial date |
31 Oct 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Feb 2021
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First version publication date |
22 Feb 2021
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Other versions |
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Summary report(s) |
PIPIN REPORT 23DEC2020 |
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 |
PIPIN
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Additional study identifiers
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ISRCTN number |
ISRCTN82984919 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Ethics: 18/ES/0007, Sponsors references: AC17099, CSO Funders reference: TCS/18/30 | ||
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Sponsors
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Sponsor organisation name |
The University of Edinburgh & Lothian Health Board
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Sponsor organisation address |
ACCORD OFFICE, QMRI, 47 Little France Cresent, Edinburgh, United Kingdom, EH16 4TJ
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Public contact |
Sonia Whyte, University of Edinburgh, +44 131 242 2693, sonia.whyte@ed.ac.uk
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Scientific contact |
Sonia Whyte, University of Edinburgh, +44 131 242 2693, sonia.whyte@ed.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 |
30 Oct 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
18 Dec 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Oct 2020
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
Feasibility study: This study is testing whether women between 28+0 and 35+6 weeks pregnant who come to hospital with signs and/or symptoms of preterm labour would be willing to take a medication (pravastatin) or placebo in a blinded fashion for 7 days.
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Protection of trial subjects |
Participants were offered a information by a member of their clinical care team at the time of presentation. Women presenting with sign of preterm labour are often anxious and consideration was provided to ensure that they had time to consider participation. Whilst the nature of the intervention is time-critical, they will of course be offered as long as required to consider participation.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Mar 2018
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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: 7
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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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) |
7
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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 |
Seven women were recruited from a single UK participating site. Women were identified in an antenatal care setting after they had presented with symptoms of preterm labour. Recruitment commenced 03rd August 2018 and the last patient visit was 29th November 2019 | |||||||||
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Pre-assignment
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Screening details |
Patient eligibility was assessed by research staff, following identification of patients by clinical staff. Of the 214 patients screened, 35 (16%; 95% CI 11.7-22.0) were found to be eligible. Of the 35 eligible participants, 27 (77%) had a positive fetal fibronectin, whilst 8 (23%) had a cervical dilation ≥ 3cm. | |||||||||
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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 |
Double blind | |||||||||
Roles blinded |
Investigator, Monitor, Data analyst, Subject | |||||||||
Blinding implementation details |
IMP supplies were purchased and repackaged by GMP compliant company ISG (Investigational Supplies Group) who performed over encapsulation of the pravastatin, and prepared the placebo to be used. Randomisation codes were supplied to ISG separately by an independent member of the Edinburgh Clinical Trials Team. Pharmacy were supplied with sealed unblinding envelopes. No women were unblinded.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Pravastatin Sodium 40mg tablets | |||||||||
Arm description |
The IMP (Pravastatin 40mg) will be manufactured by: Teva UK Limited and supplied to ISG (Investigational Supplies Group) who will performed over encapsulation of the pravastatin. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Pravastatin Sodium 40mg tablets
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Investigational medicinal product code |
PL-00289/0409
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
40mg Orally 1 dose per 24 hour period +/- 6 hours for a total of 7 days.
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Arm title
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Placebo | |||||||||
Arm description |
Matching Placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
The principal excipient in pravastatin sodium is Lactose monohydrate 286.62mg, this will be used for the placebo. It will be formulated into a Swedish Orange hard gelatin capsule, size 00.
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Baseline characteristics reporting groups
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Reporting group title |
Overall Trial
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Reporting group description |
Pregnant women | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Pravastatin Sodium 40mg tablets
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Reporting group description |
The IMP (Pravastatin 40mg) will be manufactured by: Teva UK Limited and supplied to ISG (Investigational Supplies Group) who will performed over encapsulation of the pravastatin. | ||
Reporting group title |
Placebo
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Reporting group description |
Matching Placebo | ||
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End point title |
Latency to Delivery | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Time from presentation to acute care and assessment services with suspected preterm delivery to delivery itself (Latency to Delivery), as well as gestation at delivery
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Statistical analysis title |
Methods | |||||||||
Statistical analysis description |
As this is a feasibility study, the quantitative data will be presented descriptively, using appropriate summary statistics with corresponding 95% confidence intervals. Additionally, the results will be summarised separately for the two population groups, and no formal comparisons will be made.
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Comparison groups |
Pravastatin Sodium 40mg tablets v Placebo
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Number of subjects included in analysis |
7
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Analysis specification |
Pre-specified
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Analysis type |
other [1] | |||||||||
P-value |
< 0.05 [2] | |||||||||
Method |
above not applicable | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Point estimate |
95
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
90 | |||||||||
upper limit |
100 | |||||||||
| Notes [1] - as above note [2] - not applicable for this study |
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Adverse events information [1]
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Timeframe for reporting adverse events |
All adverse events (AE) that occur after informed consent until Estimated Date of Delivery (EDD) t + 28 days
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
11
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| 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: Only 7 women participated numbers details are in the report attached there were no adverse events in the pravastatin group |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| PIPIN is a feasibility study, and by nature, sample sizes are small, limiting clinical conclusions that can be drawn from results. | |||
