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    Summary
    EudraCT Number:2020-000233-41
    Sponsor's Protocol Code Number:OPTION
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-08
    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 ConcernedSweden - MPA
    A.2EudraCT number2020-000233-41
    A.3Full title of the trial
    Labour induction in an outpatient setting - a multicenter randomized controlled trial. OPTION - OutPatienT InductiON
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Labour induction in an outpatient setting - a multicenter randomized controlled trial. OPTION - OutPatienT InductiON
    A.3.2Name or abbreviated title of the trial where available
    OPTION - OutPatienT InductiON
    A.4.1Sponsor's protocol code numberOPTION
    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 SponsorSahlgrenska University Hospital
    B.1.3.4CountrySweden
    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 supportALF-agreement funding (nr. S75710)
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportProject Grant from Dept of obstetrics and gynecology, Sahlgrenska Academy, University of Gothenburg
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska University Hospital
    B.5.2Functional name of contact pointOPTION study
    B.5.3 Address:
    B.5.3.1Street AddressDiagnosvägen 15
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41650
    B.5.3.4CountrySweden
    B.5.4Telephone number00460313436286
    B.5.6E-mailOPTION@vgregion.se
    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.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMisoprostol
    D.3.9.3Other descriptive nameMISOPROSTOL
    D.3.9.4EV Substance CodeSUB08998MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    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.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
    Induction of labour
    Igångsättning av förlossning
    E.1.1.1Medical condition in easily understood language
    Induction of labour
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To establish if induction in an outpatient setting is as safe for the child (composite outcome for mortality and severe morbidity) as induction in a hospital setting, including low-risk women only.
    2. To investigate efficacy of outpatient induction by comparing proportions of women with vaginal delivery in the whole study population as well as in the group of women induced with either balloon or prostaglandin.
    E.2.2Secondary objectives of the trial
    1. To investigate if other pregnancy and delivery-related outcomes differ btwn women induced in an outpatient vs hospital setting including safety, e.g. mother admitted to ICU, post-partum bleeding >1000ml, proportion of women delivered vaginally within 24 or 48 hrs from induction start as well as for the children, e.g. variables part of the primary safety composite outcome will be studied individually in exploratory analyses
    2. To increase the understanding of women with low-risk induction experiences of induction in an outpatient and a hospital setting by comparison of general self-efficacy (GSE), health-related quality of life (EQ-VAS, EQ-5D), pain catastrophizing (PCS), sense of coherence (SOC), anxiety and depression (HAD) before randomization and 3 mon post-delivery. Childbirth experiences (CEQ), induction experiences, EPDS and breastfeeding levels (BSES) will be compared btwn groups 3 mon post-delivery. Qualitative interviews with 20-25 women will be done 3-6 mon post-delivery
    3. To increase the understanding of partners to women with low-risk induction experiences of induction in an outpatient and a hospital setting by comparison of GSE, health-related quality of life (EQ-VAS, EQ-5D), PCS, SOC, anxiety and depression (HAD) before randomization as well as 3 mon post-delivery. Childbirth experience (FTFQ), induction experiences, and EPDS will be compared btwn groups 3 mon post-delivery. Also qualitative interviews with 20-25 partners will be performed 3-6 mon post-delivery. Partners to participating women at Sahlgrenska university hospital will be asked to answer a qualitative questionnaire 3-6 mon post-delivery
    4. To increase the understanding of the healthcare staff’s experiences of outpatient versus inpatient induction of low-risk pregnancies by qualitative interviews
    5. To study if induction in an outpatient setting is more cost-effective compared to a hospital setting
    6. To compare future pregnancy outcome in the outpatient and inpatient group
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The following four substudies are planned as tentative publications. No full titles with date and version are yet available. The general main objectives to be evaluated are indicated below for the specified populations.

    Substudy 1: Outpatient induction with oral misoprostol.
    - Population: Only those who receive oral misoprostol for induction.

    Substudy 2: Outpatient induction with a balloon catheter.
    - Population: Only those who receive balloon catheter for induction.

    Substudy 3: Womens and partners experience of outpatient induction of labour with oral misoprostol.
    - Population: Only women and partners of women who receive oral misoprostol.

    Substudy 4: Womens and partners experience of outpatient induction of labour with balloon catheter.
    - Population: Only women and partners of women who receive oral misoprostol.
    E.3Principal inclusion criteria
    Based on medical history:
    • women 18-45 years old
    • able to communicate with the hospital
    • uncomplicated live singleton pregnancy
    • pregnancy week >=37+0 to 41+6 according to crown rump length (CRL) or biparietal diameter (BPD<55 mm) at first or second trimester ultrasound
    • engaged and stable cephalic presentation

    Based on clinical examination before start of induction including Leopolds maneuvers, digital cervical exam, abdominal ultrasound, temperature, blood pressure and cardiotocography (CTG) scan:
    • engaged and stable cephalic presentation with
    • Bishop score <6 (<5 in parous women)
    • CTG classified as normal according to the antepartal Swedish Society of obstetrics and gynecology (Svensk Förening för Obstetrik och Gynekologi, SFOG) criteria (www.ctgutbildning.se)

    Based on observation the first 45 min after start of induction:
    • in case of induction with balloon method: CTG classified as normal according to the antepartal Swedish Society of Obstetrics and Gynecology (Svensk Förening för Obstetrik och Gynekologi, SFOG) criteria (www.ctgutbildning.se)
    E.4Principal exclusion criteria
    Based on medical history:
    • previous uterine surgery with uterine scar, e.g. caesarean section or myomectomy
    • pregestational or medically treated gestational diabetes (insulin or metformin)
    • dietary treated gestational diabetes with large for gestational age foetus
    • preeclampsia or instable hypertensive disease
    • multiple pregnancy
    • intrauterine foetal death (IUFD) in current or previous pregnancy
    • known foetal malformations or other foetal condition affecting the delivery or immediate care of the newborn
    • congenital uterine malformation which may affect safety
    • other condition requiring inpatient care, e.g. delivery within 60 min from arriving at the hospital in previous pregnancy
    • not able to reach the hospital in a reasonable time, at the discretion of the investigator with a maximum of 60 min as a benchmark

    Based on clinical examination before start of induction including Leopold's manoeuvres, digital cervical exam, abdominal ultrasound, temperature, blood pressure and cardiotocography (CTG) scan:
    • Small for gestational age (SGA/IUGR/FGA)
    Screened for as follows depending on the indication for induction:
    1. late term >=41+0 to 41+6 weeks:
    abdominal ultrasound will be performed and mean abdominal diameter (MAD) needs to be >= 110 mm
    In case MAD < 110 mm, the foetal weight will be estimated to exclude SGA foetus defined as <2 standard deviation according to Marsal et al.
    2. dietary treated gestational diabetes or stable hypertension:
    foetal weight estimated by abdominal ultrasound within the last two weeks before induction and showing no SGA defined as <2 standard deviation according to Marsal et al
    3. prolonged latent phase, maternal age, mild intrahepatic cholestasis, pelvic girdle pain, PROM, psychosocial:
    Normal fundal height measurement according to the Swedish reference curves is needed
    In case of not-normal fundal height measurement: foetal weight estimation must be performed and showing no SGA defined as <2 standard deviation according to Marsal et al
    4. Other indications: at the discretion of the investigator
    • oligohydramniosis: deepest vertical pocket <20 mm or amniotic fluid index <50 mm
    • polyhydramniosis if head not engaged or amniotic fluid index >300 mm
    • maternal pyrexia >= 38 degrees Celsius
    • known low-lying placenta (less than 20 mm from internal os measured by vaginal ultrasound in week 36)
    • high head (>=4/5 palpable abdominally)
    Regarding premature rupture of membranes (PROM):
    • exclusion criteria for balloon method
    • exclusion criteria for prostaglandin method if:
    o PROM >30 hours
    o Known colonisation with group B streptococci or previous pregnancy complication linked to group B streptococcus

    Based on observation the first 45 min after start of induction:
    • any adverse events within the first 45 min after start of induction, e.g. heavy bleeding, pain, PROM in case PROM was not indication for induction of labour
    • start of contractions
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety defined as a composite outcome of severe perinatal morbidity or mortality

    2. Efficacy defined as proportion of women with vaginal delivery
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. For the safety primary endpoint, neonatal mortality is defined between day 0-27 and thus the time point is day 27 after delivery.

    2. For the efficacy primary endpoint, the time point is upon delivery.
    E.5.2Secondary end point(s)
    1. Pregnancy and delivery-related outcomes (including safety, e.g. mother admitted to the intensive care unit, post-partum bleeding >1000 ml, proportion of women delivered vaginally within 24 or 48 hours from start of induction as well as for the children, e.g. the different variables being part of the primary safety composite outcome will be studied individually in form of exploratory analyses). These secondary end points are descriptive and obtained via registry data.

    2. Woman and partner's experience of self-efficacy, health-related quality of life, pain catastrophizing, anxiety and depression; women and partners' experience of childhood experiences and levels of breastfeeding; women and partners' experience as per qualitative interviews

    3. Understanding of healthcare staff's experience of outpatient vs inpatient induction of low-risk pregnancies

    4. Cost-effectiveness

    5. Future pregnancy outcome
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to 42 days after delivery. These secondary end points are descriptive and obtained via registry data.

    2. 3-6 months after delivery compared to at randomization (questionnaires will be send out three months after delivery, interviews will take place 3-6 months after delivery)

    3. At the earliest 6 months after introduction of outpatient induction

    4. Completion of follow-up

    5. 10 years after completion of recruitment
    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 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
    The aim of this study is not to test the safety/efficacy of the medication (or medical device) itself, but of taking the medication (or use of medical device) as an inpatient or at home.
    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 Yes
    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
    The medication has 2 arms and the balloon catheter has 2 arms
    We aim to test the setting and monitoring of induction - not the drug or balloon catheter itself
    E.8.2.4Number of treatment arms in the trial4
    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 concerned30
    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
    10 years after LVLS. However, the last intervention will be in connection with the last subject's last admission for delivery, but all patients will be followed for 10 years after delivery using registry data.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years14
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 8891
    F.1.1.1In Utero Yes
    F.1.1.1.1Number of subjects for this age range: 8891
    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: 8891
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    All women must provide consent, which also includes consent to collect data on their child regarding the scientific questions posed in this study. Thus the pregnant women provide consent on behalf of their child in utero and upon delivery.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state17782
    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)
    None.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Swedish Network for Clinical Studies in Obstetrics and Gynecology (SNAKS)
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-03
    P. End of Trial
    P.End of Trial StatusOngoing
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