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    Summary
    EudraCT Number:2015-000456-15
    Sponsor's Protocol Code Number:3518
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-03-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-000456-15
    A.3Full title of the trial
    The prevention of pre-term birth in women who develop a short cervix. A multi-centre randomised controlled trial to compare three treatments; cervical cerclage, cervical pessary and vaginal progesterone.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SuPPoRT: Stitch, Progesterone or Pessary: a Randomised Trial
    A.3.2Name or abbreviated title of the trial where available
    SuPPoRT: Stitch,Progesterone or Pessary: a randomised controlled trial
    A.4.1Sponsor's protocol code number3518
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKings College London
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportTommy's Charity
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuys and St THomas' NHS FOundation Trust
    B.5.2Functional name of contact pointDr Natahsa Hezelgrave
    B.5.3 Address:
    B.5.3.1Street AddressWomen's Health Academic Center, St Thomas Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE17EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 7188 3639
    B.5.6E-mailnatasha.hezelgrave@gstt.nhs.uk
    B.Sponsor: 2
    B.1.1Name of SponsorGuys and St Thomas' NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportTommy's Charity
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St THomas' NHS Foundation Trust
    B.5.2Functional name of contact pointNatasha Hezelgrave
    B.5.3 Address:
    B.5.3.1Street AddressWomens Academic Center, St THomas' Hospital
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE 1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailnatasha.hezelgrave@gstt.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cyclogest
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Vaginal capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNProgesterone PH Eur
    D.3.9.1CAS number 57-83-0
    D.3.9.3Other descriptive nameProgesterone pessaries
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Short Cervix in Pregnancy
    E.1.1.1Medical condition in easily understood language
    Short Cervix in Pregnancy
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10021632
    E.1.2Term Incompetent cervix
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For asymptomatic women at risk of preterm birth who develop a short cervix on transvaginal ultrasound scan, which is the optimal preventative strategy; cervical cerclage, arabin pessary or vaginal progesterone?
    E.2.2Secondary objectives of the trial
    Does the success of the intervention depend on early pregnancy biomarker expression?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women with singleton pregnancies who are found to have cervical length <25 mm on transvaginal ultrasound between 14+0 weeks’ gestation (dated by ultrasound or LMP and adjusted for ultrasound estimated date of delivery once ultrasound performed if no miscarriage prior to dating ultrasound) until 23+6 weeks’ gestation and one or more of the following risk factors;

    • Written informed consent to participate
    • History of
    o Previous preterm premature rupture of the fetal membranes (≤ 37 weeks’)
    o History of previous PTB/second trimester loss (≥ 16 weeks’ or ≤ 37 weeks’ gestation).
    o Any cervical procedure to treat abnormal smears i.e. large loop excision, laser conisation, cold knife conisation or radical diathermy.

    • Incidental finding of a short cervix on ultrasound scan (e.g. at the time of anomaly scan).
    E.4Principal exclusion criteria
    • Women with persistent fresh vaginal bleeding evident on speculum examination.
    • Women with visible membranes evident on speculum examination or open cervix on ultrasound scan.
    • Women with severe abdominal pain/evidence of sepsis (as judged by attending clinician).
    • Known significant congenital or structural or chromosomal fetal abnormality.
    • Suspected or proven rupture of the fetal membranes at the time of recruitment.
    • Women currently using progesterone pessaries or who have taken progesterone beyond 18 weeks gestation.
    • Women who have a cervical suture in situ.
    • Women who already have a cervical pessary in situ.
    • Insufficiuent uUnderstanding of the tTrial in the opinion of the Investigator
    • Any contraindications or cautions to the investigational medicinal product including:
    • known allergy or hypersensitivity to progesterone.
    • hepatic dysfunction,
    • undiagnosed vaginal bleeding,
    • mammary or genital tract carcinoma,
    • thrombophlebitis,
    • thromboembolic disorders,
    • cerebral haemorrhage,
    • • porphyria.
    E.5 End points
    E.5.1Primary end point(s)
    Delivery < 37 completed weeks’ gestation (powered)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Date of delivery
    E.5.2Secondary end point(s)
    i) Adverse perinatal outcome, defined as a composite outcome of death (antepartum/intrapartum stillbirths plus neonatal deaths prior to discharge from neonatal services) or one (or more) of intraventricular hemorrhage, periventricular leukomalacia, hypoxic ischemic encephalopathy, necrotizing enterocolitis, bronchopulmonary dysplasia and sepsiS.
    ii) Delivery <30 & 34 completed weeks’ gestation.
    iii) Gestation at delivery.
    iv) Time between intervention and delivery.
    v) Requirement for Rescue Cerclage (bulging fetal membranes).
    vi) Other maternal and fetal outcomes: clinical course, therapies administered, maternal and fetal morbidity and mortality data.
    vii) Participant and clinician’s perceptions of treatment: questionnaires with a selection of participants at 0-2 weeks post procedure. Questionnaires at one year are planned if funding is obtained Participant and clinician adherence to protocol
    i) Health costs at 28 days post-natal.
    ii) Biochemical end-points (if performed): endocervical swabs will be taken to determine the presence of cervico-vaginal infection and concentrations of biomarkers of preterm birth, infection and inflammation. Saliva samples will be collected for salivary hormone levels, and blood samples taken for inflammatory markers and genetic analysis. Results will be correlated with maternal and fetal outcomes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 weeks gestation - 28 days post delivery.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Cevical Cerclage (Surgical proceedure) or Cervical Pessary (Device)
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be defined as 28 days post-delivery or discharge from hospital (whichever sooner) of the last recruited participant and infant.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 540
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state540
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Not applicable, standard care applies.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-19
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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