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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-005892-83
    Sponsor's Protocol Code Number:WCH/2008/001
    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:2009-04-28
    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 number2008-005892-83
    A.3Full title of the trial
    Does metformin improve pregnancy outcomes [ incidence of LGA (≥90% birth weight centile) babies onset of maternal Gestational Diabetes, hypertension, PET, shoulder dystocia, admission to SCBU) in obese non-diabetic women?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metformin in obese non-diabetic pregnant women (MOP Trial).
    A.3.2Name or abbreviated title of the trial where available
    Metformin in Obese Non-Diabetic Pregnant Women (MOP Trial)
    A.4.1Sponsor's protocol code numberWCH/2008/001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01273584
    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 SponsorEpsom and St Helier University Hospitals NHS 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 supportEpsom and St Helier University Hospitals NHS Trust
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportFetal Medicine Foundation Charitable Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEpsom and St Helier University Hospitals NHS Trust
    B.5.2Functional name of contact pointJyoti Balani
    B.5.3 Address:
    B.5.3.1Street AddressWrythe Lane
    B.5.3.2Town/ cityCarshalton
    B.5.3.3Post codeSM5 1AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440208296 2140
    B.5.5Fax number440208644 4377
    B.5.6E-mailjyoti.balani@esth.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 Metformin 500mg
    D.2.1.1.2Name of the Marketing Authorisation holderRelonchem 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 nameMetformin
    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 INNMetformin
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Obesity in pregnancy.

    Obesity in pregnancy has been identified by Confidential Enquiry into Maternal And Child Health (CEMACH) (2008-2011) as a major health risk to mother and baby.
    E.1.1.1Medical condition in easily understood language
    Obesity in pregnancy in non-diabetic women.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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
    There is substantial evidence that obesity in pregnancy contributes to increased morbidity and mortality for both mother and baby. The purpose of the study is whether management of obese non-diabetic pregnant women with standarised lifestyle intervention (diet and physical activity) and metformin will lead to improve maternal and peri-natal outcomes compared to lifestyle intervention alone. We aim to compare peri-natal outcomes in women randomised to the two home glucose monitoring protocols:
    Group 1 - Standardised lifestyle intervention and placebo.
    Group 2 - Standardised lifestyle intervnetion and metformin.
    E.2.2Secondary objectives of the trial
    Satisfaction with maternity care will be measured using the national survey for women's experience and maternity care questionnaires.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Obese pregnant women with bmi >35
    2. Informed written consent.
    E.4Principal exclusion criteria
    1. Gestational diabetes at booking, Type I and Type II diabetes.
    2. Presence of contra indications to metformin (renal, liver and heart failure).
    3. Moving out of study area for pregnancy management.
    4. Participants who suffer with hyperemesis.
    5. Participants who are 18 years and below.
    6. Participants with high alcohol intake.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome: Birth weight centile (z-score).

    E.5.1.1Timepoint(s) of evaluation of this end point
    On the birth of the baby.
    E.5.2Secondary end point(s)
    Secondary Outcomes:

    Maternal:
    a) Maternal weight gain
    b) Maternal development of Gestational Diabetes
    c) Maternal development of hypertension/PET
    d) Caesarean section
    e) Postpartum haemorrhage
    f) Maternal Insulin Resistance and relation to Metformin efficacy
    g) Changes in circulating levels of cytokines including CRP, adiponectine, leptin and metabolic markers like uric acid and lipid profile
    h) FTO gene variant and its relation to baby outcome
    i) Changes in body composition as measured by Bioimpedence - comparison between the two groups

    Neonatal:
    a) Neonatal hypoglycemia
    b) Prematurity <37 weeks gestation
    c) Hyperbilirubinemia requiring phototherapy
    d) Polycyphaemi - cord blood hematocrit >0.6
    e) Respiratory distress
    f) Macrosomia/large for gestational age birth weight ≥90% centile based on approriate growth standards
    g) Birth trauma - shoulder dystocia, brachial plexus injury or facture
    h) Apgar score <6 at 5 minutes
    i) Admission to level 2 or greater neonatal unit including lenght of stay
    j) Neonatal body composition including skin fold thickness.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During pregnacy and after birth of baby.
    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 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) 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 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 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 concerned8
    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
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 400
    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 state400
    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)
    Since the trial is in women during pregnancy the treatment will stop after birth of the baby and then the participant will receive normal standardised treatment.
    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 Decision2009-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-08-21
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