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    Summary
    EudraCT Number:2019-004697-25
    Sponsor's Protocol Code Number:V528Nov22
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-20
    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 ConcernedIreland - HPRA
    A.2EudraCT number2019-004697-25
    A.3Full title of the trial
    The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Home Induction trial: A randomised open-label trial to assess outpatient induction of labour, and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women.
    A.3.2Name or abbreviated title of the trial where available
    IND HOME Trial
    A.4.1Sponsor's protocol code numberV528Nov22
    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 SponsorThe Rotunda Hospital
    B.1.3.4CountryIreland
    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 supportMedicem Technology SRO
    B.4.2CountryCzechia
    B.4.1Name of organisation providing supportThe Rotunda Foundation
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoyal College of Surgeons Ireland
    B.5.2Functional name of contact pointMandy Jackson
    B.5.3 Address:
    B.5.3.1Street AddressRCSI 111 St Stephens Green
    B.5.3.2Town/ citydublin
    B.5.3.3Post codeDublin 2
    B.5.3.4CountryIreland
    B.5.4Telephone number+35318093863
    B.5.6E-mailmandyjackson@rcsi.com
    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 Propess
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Ireland Ltd
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 delivery system
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    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
    Normal risk nulliparous women who have no pregnancy-related or medical contraindication to Induction of Labour
    E.1.1.1Medical condition in easily understood language
    Normal risk nulliparous women who have no pregnancy-related or medical contraindication to Induction of Labour
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10055563
    E.1.2Term Labor induction
    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
    To demonstrate non-inferiority in the efficacy of Dilapan-S® (12 hours or 24 hours insertion) to Propess for outpatient induction of labour at 39 weeks’ gestation in otherwise uncomplicated, normal risk* nulliparous women.

    the following conditions should be met to consider a pregnancy to be normal risk
    Singleton pregnancy
    Cephalic presentation
    Term gestation (37-39 weeks gestational age)
    Maternal pre-pregnancy body mass index < 35kg/m2
    Maternal age of ≥ 18 and < 40 years
    No evidence of the following conditions:
    Pre-pregnancy diabetes
    Gestational diabetes
    Pre-pregnancy hypertension
    Cervical cerclage in situ
    Premature rupture of membranes
    Congenital fetal anomalies
    E.2.2Secondary objectives of the trial

    1) To compare the Dilapan-S® (12 hours) group to the Propess group in the primary endpoint and secondary endpoints (see Section 10.3 for further details)
    2) To compare the the Dilapan-S® (24 hours ) group to the Propess group in the primary endpoint and secondary endpoints (see Section 10.3 for further details)
    3) To compare the Dilapan-S® (12 hours) group to the Dilapan-S® (24 hours ) group in the primary endpoint and secondary endpoints (see Section 10.3 for further details)
    4) To compare rates of vaginal delivery in the Dilapan-S® 12-hour group, the Dilapan-S® 24-hour group and the Propess at 36 hours, 48 hours and 48 hours respectively from insertion time to delivery (see Section 10.3 for further details)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria

    • Normal risk nulliparous women (as defined in trial objectives)
    • Age ≥18 and <40 years
    • Singleton pregnancy
    • No contraindications to induction of labour
    • Must agree to outpatient induction at 39 weeks
    • No relevant medical issues in or outside of pregnancy. This is assessed by a doctor on a case by case basis. Relevant medical issues would be inclusive of the systems disorders as in exclusion criteria. Non relevant medical issues may include, but are not limited to: anxiety/depression not requiring medications, history of urinary tract infections, past history of sexually transmitted infections that have been successfully treated, history of abnormal cervical smear tests, incidence of human papillomavirus, varicose veins, minor surgery or any surgery that would not result in contraindication to induction of labour)
    • Must live within 30 minutes or 15km of hospital and have transport to hospital at all times during induction period
    • A normal amniotic fluid index (AFI) at 39 weeks’ gestation is between 8 cm and 20 cm
    • Biophysical Profile Score (BPS) is 8/8
    • Bishops score <6 at Visit 2
    E.4Principal exclusion criteria
    • Multiparous women
    • Women with uterine scar
    • Women with low lying placenta
    • Women with BMI > 35kg/m2
    • Multiple gestation
    • Known fetal anomaly or fetal growth restriction or oligohydramnios
    • Known maternal health problem e.g. Hypertensive disease, cardiac disease, renal disease, diabetes, pulmonary disease, hepatic disease which would directly affect the risk status of the woman. This is assessed clinically on a case by case basis.
    • Women with no transport to hospital or women who live >30 mins or >15km from the hospital
    • Patients who have difficulty understanding the required protocol and follow up instructions (e.g. language barriers)
    • Women <39+0 or greater than 39+4 weeks’ gestation at the time of induction of labour (Visit 2)
    -Gestational age will be based on initial dating scan between 7-14 weeks, which confirms gestational age by CRL.
    • Any factor which is a contraindication to induction of labour
    • Contraindications to trial treatment include patients that fall into any of the following categories:

    o If labour has started.
    o If oxytocic drugs and/or other labour induction agents have been given.
    o When strong prolonged uterine contractions would be inappropriate
    o Patients who have had previous major uterine surgery, e.g. Caesarean section, myomectomy
    o Patients with a clinical suspicion for cephalopelvic disproportion
    o Patients with fetal malpresentation
    o Patients with suspicion or evidence of non-reassuring fetal testing
    o Who have had previous major surgery (e.g. Other than biopsies and cervical abrasion) or rupture of the uterine cervix
    o When there is current pelvic inflammatory disease, unless adequate prior treatment has been instituted.
    o Patients with hypersensitivity to dinoprostone or to any of the excipients listed in the SmPC for Propess/Prostin
    o Patients with placenta previa or unexplained vaginal bleeding during the current pregnancy.
    o Patients with evidence or any sign of infection, including genital tract infection
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure (efficacy measure) is failure to achieve vaginal delivery (or, equivalently, operative vaginal delivery or SVD) at any time. This will allow assessment of effective methods of IOL in the outpatient setting. The window for induction will be 39+0 to 39+4 weeks gestation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    39+0 to 39+4 weeks gestation.
    E.5.2Secondary end point(s)
    1. Overall change in Bishop score before and after cervical ripening
    2. Rates of vaginal delivery at 36 hours after insertion of either Propess or Dilapan-S®
    3. Rates of vaginal delivery at 48 hours after insertion of either Propess or Dilapan-S®
    4. The need for second induction modality
    5. Rates of hyper-stimulation*
    6. Rate of failed induction
    7. Overall length of stay in hospital
    8. Rates of adverse neonatal outcome
    9. Rates of adverse maternal outcomes
    10. Maternal satisfaction scores with the outpatient induction process
    11. Caesarean delivery rates, categorized by “overall rate”, “rate for failure to progress/failed induction”, and “rate for non-reassuring fetal testing”
    12. Analgesia use in each group, including rates of epidural
    13. Compare rates of 39 weeks’ successful vaginal delivery in the outpatient setting to rates of successful vaginal delivery in the inpatient setting**.

    *defined as more than 7 contractions in a 15 minute time period persistently for more than 30 minutes and requiring a medical intervention (such as a clinical decision to remove the Propess/Dilapan or administer a medication such as Terbutaline).

    **defined as a group of low risk nulliparous women who did not undertake elective induction of labour at 39 weeks as part of this trial.
    E.5.2.1Timepoint(s) of evaluation of this end point
    39+0 weeks gestation to 6 weeks postpartum (+/- days)
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 defined as the date of the 6 week post-partum consultation for the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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.1.1.1In 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.1.2.1Number of subjects for this age range: 327
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state327
    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)
    There will be no arrangements to provide the IMPs to trial participants post trial as this study is specific to Induction of labour.
    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 Decision2020-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-28
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