Clinical Trial Results:
Prevention of preterm birth in women at risk identified by ultrasound: evaluation of two
treatment strategies.
Summary
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EudraCT number |
2012-000241-13 |
Trial protocol |
ES |
Global end of trial date |
23 Mar 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Mar 2022
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First version publication date |
15 Mar 2022
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Other versions |
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Summary report(s) |
Cervical_Pessary_Compared_With_Vaginal.15.aspx |
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 |
PESAPRO
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01643980 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Hospital Universitario Puerta de Hierro Majadahonda
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Sponsor organisation address |
Clinical Pharmacology, Manuel de Falla 1, Majadahonda, Madrid, Spain, 28222
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Public contact |
Cristina Avendaño-Solá, Servicio de Farmacologia Clínica, 0034 911916479, farmacologia_clinica@idiphim.org
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Scientific contact |
Cristina Avendaño-Solá, Servicio de Farmacologia Clínica, 0034 911916479, farmacologia_clinica@idiphim.org
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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 |
01 Mar 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Mar 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Mar 2016
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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 |
To compare the effectiveness of a cervical pessary and vaginal progesterone to prevent spontaneous preterm births in pregnant women with cervical lengths
25 mm or less as measured by transvaginal ultrasonography
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Protection of trial subjects |
Both treatment arms are standard treatments and no additional risk or painful procedures are performed. Enrolled women had access to the clinical investigator in case of intercurrent events.
Although a third control arm with placebo would have been very valuable from a methodological point of view in a noninferiority comparative trial, it was discarded by ethical and feasibility reasons, as most participant hospitals were already treating these women with a short cervix (either with a pessary
or with progesterone) as a measure to decrease the risk of preterm birth, based on recent publications.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Apr 2012
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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 |
Spain: 254
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Worldwide total number of subjects |
254
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EEA total number of subjects |
254
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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) |
254
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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 |
- | |||||||||||||||||||||
Pre-assignment
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Screening details |
All participating Obstetrics Units routinely perform transvaginal ultrasonography in the second term as a screening diagnosis method to detect women at risk of preterm birth. Women identified at that tiem point were offered to participate. | |||||||||||||||||||||
Period 1
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Period 1 title |
baseline
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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cervical pessary | |||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||
Arm type |
medical device | |||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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progesterone | |||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
progesterone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Vaginal tablet
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Routes of administration |
Vaginal use
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Dosage and administration details |
200 mg micronized progesterone per day by vaginal route (women self-administered the medicine once daily, preferably before going to bed)
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Period 2
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Period 2 title |
overall trial
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Is this the baseline period? |
No | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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cervical pessary | |||||||||||||||||||||
Arm description |
Perforated-cerclage type pessary, a hypoallergenic silicon medical device certified by European Conformity, size 65/25/32 (65 mm lower larger diameter, 25 mm height and 32 mm upper smaller diameter). The pessary is placed and removed by the Obstetrician at the clinic. | |||||||||||||||||||||
Arm type |
medical device | |||||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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progesterone | |||||||||||||||||||||
Arm description |
vaginal progesterone (200 mg/24 hours) | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
progesterone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Vaginal tablet
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Routes of administration |
Vaginal use
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Dosage and administration details |
200 mg micronized progesterone per day by vaginal route (women self-administered the medicine once daily, preferably before going to bed)
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Baseline characteristics reporting groups
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Reporting group title |
baseline
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The per-protocol subset will be used to test the noninferiority hypothesis.
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End points reporting groups
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Reporting group title |
cervical pessary
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Reporting group description |
- | ||
Reporting group title |
progesterone
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Reporting group description |
- | ||
Reporting group title |
cervical pessary
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Reporting group description |
Perforated-cerclage type pessary, a hypoallergenic silicon medical device certified by European Conformity, size 65/25/32 (65 mm lower larger diameter, 25 mm height and 32 mm upper smaller diameter). The pessary is placed and removed by the Obstetrician at the clinic. | ||
Reporting group title |
progesterone
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Reporting group description |
vaginal progesterone (200 mg/24 hours) | ||
Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The per-protocol subset will be used to test the noninferiority hypothesis.
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End point title |
spontaneous preterm delivery before 34 weeks of gestation [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
34 weeks gestation
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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: I cannot include the right numbers in the system. Please, see the attached published paper for the statistical analysis |
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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 |
All women followed until delivery
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17
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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: Difficult to include the right numbers in the system. Please, see the attached published paper for adverse events reporting |
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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. | |||
None reported | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30204689 |