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    Summary
    EudraCT Number:2008-002031-32
    Sponsor's Protocol Code Number:PASS-2007
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-05-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-002031-32
    A.3Full title of the trial
    Phase III study protocol to compare conservative and active treatment during the third stage of labour in physiological childbirth
    Protocollo di studio di fase III sull'efficacia del trattamento passivo o attivo del terzo stadio del travaglio in parti fisiologici
    A.3.2Name or abbreviated title of the trial where available
    PASS-2007
    PASS-2007
    A.4.1Sponsor's protocol code numberPASS-2007
    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 SponsorAZIENDA OSPEDALIERA S. GERARDO DI MONZA
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 SYNTOCINON
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxytocin and analogues
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.3Concentration number25
    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.IMP: 2
    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 METHERGIN
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMethylergometrine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number.2
    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
    THIRD STAGE OF LABOR MANAGEMENT
    TRATTAMENTO DEL TERZO STADIO DEL TRAVAGLIO DI PARTO
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10029759
    E.1.2Term Normal delivery
    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
    The primary target of this study is to proof in physiological childbirths that the conservative treatment in respect with the active treatment of the third childbirth stage does not increase post-partum haemorrhage (PPH) Secondary principle target is to proof that the conservative treatment in respect with the active one in third childbirth stage does not increase maternal anaemia.
    Obiettivo primario di questo studio di non inferiorita` e`: dimostrare che il trattamento di attesa rispetto al trattamento attivo del terzo stadio del travaglio non comporta un aumento clinicamente rilevante di incidenza delle emorragie post-partum (PPH) in parti 'fisiologici' Obiettivo secondario principale e`: dimostrare che il trattamento passivo rispetto al trattamento attivo del terzo stadio del travaglio non comporta un aumento di incidenza di anemia materna in parti a termine non complicati
    E.2.2Secondary objectives of the trial
    1. Duration of the third stage 2. Manual removal of the placenta 3. Need for therapeutic uterotonics 4. Bonding at the birth 5. Early breastfeeding 6. Increased maternal blood pressure during post-patum 7. Nausea and vomiting 8. Need for analgesic during post-partum 9. Fluid infusion after blood lost 10. Iron tablets 11. Neonatal hypothermia 12. Neonatal jaundice 13. Duration of phtotherapic treatment 14. Type of phtotherapic treatment 15. Infant haemoglobin and haematocrit 16. Woman's discharge 17. Baby's discharge 18. Admission to NICU 19. Woman's satisfaction 20. Breastfeeding at discharge and after 30 days
    Altri obiettivi secondari riguardano il confronto dei due gruppi in termini di: 1.Durata del terzo stadio del travaglio 2.Incidenza di secondamenti manuali 3.Uso di uterotonici aggiuntivi 4.Bonding alla nascita 5.Attaccamento precoce 6.Aumento della pressione arteriosa nel post-partum 7.Incidenza di nausea e vomito 8.Uso di antidolorifici nell'immediato post partum 9.Necessita` di terapia infusionale per il ripristino della perdita ematica 10.Necessita` di terapia marziale 11.Ipotermia neonatale 12.Incidenza di ittero neonatale patologico 13.Ore di trattamento fototerapico 14.Tipo di trattamento fototerapico 15.Emoglobinemia ed ematocrito neonatali 16.Durata del ricovero della puerpera 17.Durata del ricovero del neonato 18.Ricoveri dei neonati in terapia intensiva neonatale (TIN) 19.Soddisfazione materna 20.Allattamento alla dimissione e a 30 giorni di vita
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • To be of age (= o >18) • Woman at 37 th to 41+5 week of pregnancy • Single pregnancy and cephalic presentation • Spontaneous labour
    Verranno incluse nello studio partorienti con le seguenti caratteristiche: • Maggiore eta` (= o &gt;18 anni) • Gravidanza a termine: epoca gestazione &gt; o = 37 settimane gestazionali e &lt; o = 41+5 settimane gestazionali • Feto singolo in presentazione di vertice • Travaglio insorto spontaneamente
    E.4Principal exclusion criteria
    AT ARRIVAL IN THE DELIVERY ROOM • Prematurity < 37 week • Pregnancy > 42 week Previous CS • Fetal growth restriction • Macrosomia • Multiple pregnancies • Breech presentation • Polihydramios • Oligohydramnios • Body Max Index (BMI) >35 • 4 or more previus babies • Antenatal risk factor • Previous CS • Abnormalities of the uterus • Inducet labour • Antepartum haemorrhage • Maternal haematocrit level below < o = 25% FIRST STAGE • After a dilation of 8 cm use of Amniotomy and use of oxytocin • Maternal pyrexia > o = 38° C • Epidural analgesia • SECOND STAGE • Water birth • Use of vacuum extraction • Mediolateral Episiotomy
    Non potranno essere incluse nello studio le partorienti che presentino una delle seguenti caratteristiche: ALL'INGRESSO IN SALA PARTO: • Gravidanza pre-termine &lt;37 settimane gestazionali • Gravidanza oltre il termine &gt;41+5 settimane gestazionali • Iposviluppo diagnosticato clinicamente e/o ecograficamente (circonferenza addominale &lt;5°centile) • Macrosomia: peso fetale previsto &gt;4000gr • Gravidanza gemellare • Presentazione podalica • Polidramnios = falda massima = o &gt;8 cm • Oligoidramnios= falda massima = o &lt; 2 cm nella gravidanza pretermine e AFI = o &lt; 6 nella gravidanza a termine • Obesita` materna: Body Max Index (BMI)&gt; 35 • Grande pluriparita`, definita come numero di parti pregressi &gt;4 • Fattori di rischio preesistenti • Pregresso taglio cesareo o apertura cavita` • Mioma o malformazione uterina. • Induzione del travaglio • Pregressa atonia riferita dalla pz • Anemia materna = Ematocrito = o &lt; 25 % eseguito all'ingresso in sala parto tramite prelievo da capillare I STADIO DEL TRAVAGLIO • Accelerazione del travaglio con amnioressi &lt;8 cm di dilatazione cervicale e/o somministrazione di ossitocina endovena • Iperpiressia = temperatura corporea ascellare &gt; o = 38°C per due rilevazioni consecutive • Analgesia epidurale II STADIO DEL TRAVAGLIO • Parto in acqua • Parto operativo = applicazione in periodo espulsivo di ventosa sullo scalpo fetale o esecuzione della manovra di Kristeller sull'addome materno. • Episiotomia paramediana
    E.5 End points
    E.5.1Primary end point(s)
    • PPH: estimate blood loss 500 ml or grater • Severe PPH: estimate blood loss 100 ml or greater • After delivery (24 hours) maternal anemia: haemoglobin level below 9 g/dl
    • Emorragia post-partum: perdita ematica > o = 500 ml nella prime 24 ore dopo il parto. • Emorragia post partum severa: perdita ematica > o = 1000 ml nelle prime 24 ore dopo il parto. • Anemia materna: emoglobina <9 g/dl a 48 ore dal parto.
    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 No
    E.6.4Safety No
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.6Cross over Yes
    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
    TRATTAMENTO CLINICO ASSISTENZIALE
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state1453
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-28
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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