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    Summary
    EudraCT Number:2013-003810-42
    Sponsor's Protocol Code Number:Version2.0;18/12/2013
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-03-31
    Trial results View 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 number2013-003810-42
    A.3Full title of the trial
    A pragmatic group sequential placebo controlled randomised trial to determine the effectiveness of Glyceryl trinitrate for retained placenta (GOT-IT Trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glyceryl trinitrate spray for retained placenta (GOT-IT Trial)
    A.3.2Name or abbreviated title of the trial where available
    Glycerine Trinitrate for Retained Placenta (GOT-IT Trial)
    A.4.1Sponsor's protocol code numberVersion2.0;18/12/2013
    A.5.4Other Identifiers
    Name:EudraCTNumber:2013-003810-42
    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 SponsorUniversity of Edinburgh (ACCORD)
    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 supportHealth Technology Assessment
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe University of Edinburgh
    B.5.2Functional name of contact pointFiona Denison
    B.5.3 Address:
    B.5.3.1Street AddressMRC / University of Edinburgh Centre for Reproductive Health
    B.5.3.2Town/ city47 Little France Crescent
    B.5.3.3Post codeEH16 4TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01312426449
    B.5.6E-mailfiona.denison@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian (ACCORD)
    B.1.3.4Country
    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 supportHealth Technology Assessment
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointFiona Denison
    B.5.3 Address:
    B.5.3.1Street AddressMRC / University of Edinburgh Centre for Reproductive Health
    B.5.3.2Town/ city47 Little France Crescent
    B.5.3.3Post codeEH16 4TJ
    B.5.4Telephone number0131 242 6449
    B.5.6E-mailfiona.denison@ed.ac.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 Glyceryl trinitrate
    D.2.1.1.2Name of the Marketing Authorisation holderAyrton Saunders 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.3.1Product nameGlyceryl trinitrate
    D.3.4Pharmaceutical form Oromucosal drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSublingual use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlyceryl trinitrate
    D.3.9.1CAS number 55-63-0
    D.3.9.2Current sponsor codeGOT-IT.Version1.0
    D.3.9.3Other descriptive nameGTN
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOromucosal drops
    D.8.4Route of administration of the placeboSublingual use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Retained placenta
    E.1.1.1Medical condition in easily understood language
    After a baby is born, the placenta (afterbirth) should be delivered. Sometimes this does not occur and the placenta gets stuck. This medical condition is called a retained placenta.
    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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10038757
    E.1.2Term Retained placenta
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10038350
    E.1.2Term Removal retained placenta
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary research objectives of the internal pilot RCT are:
    1) To demonstrate trial processes for approaching women, gaining consent, randomising, treating and assessing outcomes are optimal, and to implement improvements as required;
    2) To determine achievable recruitment rates;
    3) To determine the likely effect size, to inform a calculation on whether the planned sample size can be reduced whilst maintaining study power;
    4) To pilot and modify if required the post-partum questionnaires (assessment of patient satisfaction and collection of health service use outcomes).

    The primary research objectives of the substantive GOT-IT RCT are:
    1) To determine the clinical effectiveness of sublingual GTN in treating RP and avoiding MROP in women with vaginal delivery following failure of current management (defined as a third stage of labour lasting more than 30 mins after active management or 60 mins after physiological followed by active management respectively) (clinical domain);
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess NHS costs in relation to the primary outcome and range of secondary outcomes expected to differ between arms of the trial, using a cost-consequence balance sheet approach.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women with Retained Placenta.
    - Women aged 16 or over.
    • Women with vaginal delivery (including women with a previous caesarean section).
    • Haemodynamically stable (systolic blood pressure more than 100mg Hg and pulse less than 110 beats per min).
    • > 14 weeks gestation.
    E.4Principal exclusion criteria
    • Unable to give informed consent.
    • Suspected placenta accreta/increta/percreta.
    • Multiple pregnancy.
    • Women having an instrumental vaginal delivery.
    • Allergy or hypersensitivity to nitrates or any other constituent of the formulation.
    • Taken alcohol in the last 24 hours.
    • Concomitant use with phosphodiesterase inhibitors (such as sildenafil, tadalafil, or vardenafil).
    • Currently participating in another CTIMP.
    - Contra-indication due to one of the following: Severe anaemia, constrictive pericarditis, extreme bradycardia, incipient glaucoma, Glucose-6-phosphatedehydrogenase-deficiency, cerebral haemorrhage and brain trauma, aortic and / or mitral stenosis and angina caused by hypertrophic obstructive cardiomyopathy. Circulatory collapse, cardiogenic shock and toxic pulmonary oedema.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcomes will be measured over four interrelated domains of clinical, safety, patientsided
    and economic.
    1) Clinical: need for MROP, defined as the placenta remaining undelivered 15 minutes
    post study treatment and/or being required within 15 minutes of treatment due to
    safety concerns.
    2) Safety: measured blood loss between administration of treatment and transfer to the
    postnatal ward or other clinical area (e.g. labour ward high dependency).
    3) Patient-sided: satisfaction with treatment and side effect profile assessed by
    questionnaire. It will be informed by our qualitative studies and based on
    questionnaires we have previously used to assess satisfaction.[22]
    4) Economic: Net incremental costs (or cost savings) to the National Health Service of
    using GTN versus standard practice. Costs will include GTN (dose and time to
    administer drug, monitor woman and deliver the placenta if effective), MROP, and
    further health service resource use to six weeks postnatal (as measured by the health
    service resource use questionnaire).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please see timepoints specified above.
    E.5.2Secondary end point(s)
    Secondary outcomes will be measured over two interrelated domains of clinical and economic
    outcomes. The feasibility of the collection of secondary outcomes will be tested during the
    internal pilot phase.
    1) Clinical outcomes:
    i) Fall in haemoglobin of more than 15% between recruitment and the first postnatal
    day;
    ii) time from randomisation to delivery of placenta;
    iii) MROP in theatre;
    iv) need for earlier than planned MROP on the basis of the clinical condition;
    v) fall in systolic or diastolic blood pressure of more than 15mmHg and/or increase in
    pulse of more than 20 beats/minute between baseline and 5 and 15 minutes postadministration
    of active/placebo treatment;
    vi) need for blood transfusion between time of delivery and discharge from hospital;
    vii) need for general anaesthesia;
    viii) maternal pyrexia (one or more temperature reading of more than 38°C within
    72hrs of delivery or discharge from hospital if discharge occurs sooner);
    ix) sustained uterine relaxation after removal placenta requiring uterotonics;
    2) Costs: The mean costs will be summarised by treatment allocation group, and the
    incremental cost (cost saving) associated with the use of GTN will be estimated using
    an appropriately specified general linear model. The cost data will be presented
    alongside the primary and secondary outcome data in a cost-consequence balance
    sheet, indicating which strategy each outcome favours.
    There are no secondary patient-sided or safety outcomes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see timepoints specified above.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Patient satisfaction
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned20
    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 is defined as the return of the 6 week postnatal questionnaire by the last participant in the trial.
    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 months5
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1000
    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 No
    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 No
    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 state1086
    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)
    It is not applicable for continued provision of the intervention in this context as the placenta will have been delivered once the research has finished.
    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 Decision2014-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-05
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