Trial from ANZCTR


Trial ID ACTRN12607000551493
Trial Status: Registered
Date Submitted: 18/10/2007
Date Registered: 26/10/2007
Retrospectively registered

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Public title Screening for pregnancy endpoints: preeclampsia, growth restricted baby and spontaneous preterm birth.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Screening nulliparous women to identify the combinations of clinical risk factors and/or biomarkers required to predict preeclampsia, small for gestational age babies and spontaneous preterm birth.
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UTN
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Trial acronym SCOPE; (Also known in the in the United Kingdom as MAPS in Ireland as SCOPE Ireland).
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Page 2

Health condition(s) or problem(s) studied:
Preeclampsia. 2319 0
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 Reason:
Small for gestational age babies (SGA). 2320 0
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Spontaneous preterm birth. 2321 0
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Condition category: Condition code:
Reproductive Health and Childbirth Fetal medicine and complications of pregnancy
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2422 2422 0 0

Page 3

Descriptions of intervention(s) / exposure Prospective cohort, with case cohort design. The cohort comprises nulliparous women with a singleton pregnancy in New Zealand, Australia, United Kingdom and Ireland who are prospectively studied from 14 weeks gestation to postpartum. Cases are women who develop one or more of the following conditions: preeclampsia, an SGA baby or spontaneous preterm birth. For all secondary endpoints the cases will be women with the secondary endpoint of interest.
Data on all known risk factors for preeclampsia, spontaneous preterm birth and SGA are collected at 15+/-1 and 20 +/-1 weeks’ gestation by interview and examination of the women. Blood and urine specimens are obtained at both time points, with a high vaginal swab taken at the 20 week visit. Additional information is collected about diet, lifestyle, stress, depression and other mood disorders. Ultrasound data are obtained at 20 weeks on fetal measurements, anatomy, uterine and umbilical artery Doppler and cervical length. Fetal growth, uterine and umbilical Dopplers are measured at 24 weeks. Pregnancy outcome is tracked and the woman seen within 48 hours of delivery. Baby measurements are obtained within 48 hours of delivery.
Proteomic, targeted genomic and metabolomic studies are being performed to identify biomarkers, which will then be evaluated and validated as screening tests by using quantitative, high throughput methods (such as multiplex immunoassay) to measure specific analytes in the cohort. These data will then be used to develop predictive algorithms based on clinical risk factors alone, biomarkers alone or combinations of both.
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Intervention Code:
Early detection / Screening 2039 0
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Comparator / control treatment In the main cohort study, when the outcome is preeclampsia, controls are women without preeclampsia. For SGA, controls are women without SGA. For spontaneous preterm birth, controls are women without spontaneous preterm birth. A case cohort design will be used when investigating prediction based on blood biomarkers, with controls comprising women randomly selected from the non-disease groups described above.
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Control group Uncontrolled
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Primary Outcome: Preeclampsia defined as gestational hypertension (systolic blood pressure (BP) >= 140 mmHg and/or diastolic BP >= 90mmHg (Korotkoff V) on at least 2 occasions 4 hours apart after 20 weeks gestation but before the onset of labour) or postpartum systolic BP >= 140 mmHg and/or diastolic BP >= 90mmHg postpartum on at least 2 occasions 4 hours apart with proteinuria >= 300 mg/24h or spot urine protein: creatinine ratio >=30 mg/mmol creatinine or urine dipstick protein >= ++ or any multi-system complication of preeclampsia.
Multisystem complications include any of the following:
1. Acute renal insufficiency defined as a new increase in serum creatinine >=100 umol/L antepartum or >130 umol/L postpartum
2. Liver disease defined as raised aspartate transaminase and/or alanine transaminase >45 IU/L and/or severe right upper quadrant or epigastric pain or liver rupture
3. Neurological problems defined as eclampsia or imminent eclampsia (severe headache with hyperreflexia and persistent visual disturbance) or cerebral haemorrhage
4. Haematological including thrombocytopenia (platelets <100 x 109/L), disseminated intravascular coagulation or haemolysis, diagnosed by features on blood film (e.g., fragmented cells, helmet cells) and reduced haptoglobin.
3319 0
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Timepoint: At any stage during pregnancy after recruitment until delivery or in the first 2 weeks after delivery. 3319 0
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Primary Outcome: SGA defined as: birthweight <10th% using customized centiles, adjusted for maternal weight, height, parity, ethnicity and infant sex. 3320 0
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Timepoint: First 24 hours after baby's birth. 3320 0
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Primary Outcome: Spontaneous preterm birth defined as spontaneous preterm labour or preterm premature rupture of the membranes (PPROM) resulting in preterm birth at <370 weeks. 3321 0
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Timepoint: When the mother has given birth to the baby. 3321 0
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Secondary Outcome: Early onset preeclampsia defined as preeclampsia resulting in delivery at <340 weeks. 5530 0
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Timepoint: At any stage during pregnancy after recruitment until delivery or in the first 2 weeks after delivery. 5530 0
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Secondary Outcome: Preeclampsia with severe fetal or neonatal complications defined as preeclampsia resulting in either delivery at <320 weeks or major neonatal morbidity or stillbirth or neonatal death or post-neonatal death. Preterm major neonatal morbidity is defined as one or more of the following amongst babies delivered before 37 weeks: Grade III or IV intraventricular haemorrhage, chronic lung disease, necrotizing enterocolitis, retinopathy of prematurity stage 3 or 4, sepsis (blood or CSF culture proven) or cystic peri-ventricular leukomalacia. These conditions will be defined using the Australian and New Zealand neonatal network definitions. Term major neonatal morbidity is defined as one or more of the following amongst babies delivered at or after 37 weeks gestation: Grade II or III hypoxic ischemic encephalopathy, ventilation>24 hours, neonatal unit admission >4 days, Apgars <4 at 5 mins, cord arterial pH<7.0 and/or base excess >-15 or neonatal seizures. 5531 0
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Timepoint: When the mother has given birth to the baby or at the time of baby death or baby discharge from the neonatal nursery. 5531 0
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Secondary Outcome: Preeclampsia with severe maternal complications defined as the development of preeclampsia with one or more of the following: maternal death, persistent severe hypertension (systolic blood pressure >=170 mmHg or diastolic blood pressure >=110 mmHg on more than one occasion antepartum or postpartum) or multi-system complication as defined above. 5532 0
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Timepoint: At any stage during pregnancy after recruitment until delivery or in the first 2 weeks after delivery. 5532 0
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Secondary Outcome: Preeclampsia with either severe maternal complication or severe fetal or neonatal complications includes all preeclamptic pregnancies affected by severe maternal or severe fetal or neonatal complications as defined above. 5803 0
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Timepoint: Preeclampsia with severe maternal complications: at any stage during pregnancy after recruitment until delivery or in the first 2 weeks after delivery. Preeclampsia with severe fetal or neonatal complications: When the mother has given birth to the baby or at the time of baby death or baby discharge from the neonatal nursery. 5803 0
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Secondary Outcome: Early onset SGA defined as birthweight <10th customised centile resulting in delivery at <340 weeks. 5804 0
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Timepoint: First 24 hours after baby's birth. 5804 0
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Secondary Outcome: SGA with severe fetal or neonatal complications defined as SGA and either delivery at <320 weeks or major neonatal morbidity or stillbirth or neonatal death or post-neonatal death. Preterm major neonatal morbidity is defined as one or more of the following amongst babies delivered before 37 weeks: Grade III or IV intraventricular haemorrhage, chronic lung disease, necrotizing enterocolitis, retinopathy of prematurity stage 3 or 4, sepsis (blood or CSF culture proven) or cystic peri-ventricular leukomalacia. These conditions will be defined using the Australian and New Zealand neonatal network definitions. Term major neonatal morbidity is defined as one or more of the following amongst babies delivered at or after 37 weeks gestation: Grade II or III hypoxic ischemic encephalopathy, ventilation>24 hours, neonatal unit admission >4 days, Apgars <4 at 5 mins, cord arterial pH<7.0 and/or base excess>-15 or neonatal seizures. 5805 0
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Timepoint: When the mother has given birth to the baby or at the time of baby death or baby discharge from the neonatal nursery. 5805 0
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Secondary Outcome: Early onset spontaneous preterm birth defined as spontaneous preterm labour or PPROM resulting in delivery at <340 weeks. 5806 0
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Timepoint: When the mother has given birth to the baby. 5806 0
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Secondary Outcome: Spontaneous preterm birth with severe fetal or neonatal complications defined as spontaneous preterm labour or PPROM resulting in either delivery at <320 weeks or spontaneous preterm birth resulting in major neonatal morbidity or stillbirth or neonatal death or post-neonatal death. Preterm major neonatal morbidity is defined as one or more of the following amongst babies delivered before 37 weeks Grade III and IV intraventricular haemorrhage, chronic lung disease, necrotizing enterocolitis, retinopathy of prematurity, stage 3 or 4, sepsis (blood or CSF culture proven) or cystic peri-ventricular leukomalacia. These conditions will be defined using the Australian and New Zealand neonatal network definitions. 5807 0
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Timepoint: When the mother has given birth to the baby or at the time of baby death or baby discharge from the neonatal nursery. 5807 0
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Secondary Outcome: 9: Spontaneous preterm birth with PPROM defined as preterm birth at <370 weeks following PPROM. 5808 0
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Timepoint: When the mother has given birth to the baby. 5808 0
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Secondary Outcome: 10: Spontaneous preterm birth without PPROM defined as spontaneous preterm labour with intact membranes resulting in preterm birth at <370 weeks preterm birth. 5809 0
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Timepoint: When the mother has given birth to the baby. 5809 0
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Key inclusion criteria Nulliparous women, with a singleton pregnancy, between 14wks 0 days and 16wks 6 days gestation who give informed consent to participate in SCOPE.
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Minimum age No limit
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Maximum age No limit
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Gender Females
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Healthy volunteers? Yes
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Key exclusion criteria Exclusion criteria: Unsure of last menstrual period (LMP) and unwilling to have ultrasound scan at <= 20 weeks, > =3 miscarriages, >=3 terminations, major fetal anomaly/abnormal karyotype, essential hypertension treated pre-pregnancy, moderate-severe hypertension at booking >=160/100 mmHg, diabetes, renal disease, systemic lupus erythematosus, anti-phospholipid syndrome, sickle cell disease, HIV positive, major uterine anomaly, cervical suture, knife cone biopsy, ruptured membranes now, long term steroids, treatment low-dose aspirin, treatment calcium (>1g/24h), treatment eicosopentanoic acid (fish oil), treatment vitamin C >=1000mg & Vit E >=400iu, treatment heparin/low molecular weight heparin.
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Study type Observational
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Patient registry
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Target follow-up duration  
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Purpose Screening
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Duration Longitudinal
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Selection Defined population
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Timing Prospective
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 11/11/2004
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 7500
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 5112 467 0
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Recruitment outside Australia

Country: New Zealand 584 0
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State/Province: 584 0
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Country: United Kingdom 585 0
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State/Province: 585 0
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Country: Ireland 586 0
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State/Province: 586 0
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Page 8

Funding Source: Government body 2582 0
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Name: Foundation of Research Science and Technology 2582 0
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Address: PO Box 12-240
Wellington
2582 0
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Country: New Zealand 2582 0
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Funding Source: Government body 2717 0
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Name: Health Research Council 2717 0
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Address: PO Box 5541
Wellesley St
Auckland
2717 0
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Country: New Zealand 2717 0
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Funding Source: Hospital 2718 0
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Name: Evelyn Bond Charitable Fund 2718 0
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Address: Auckland District Health Board
PO Box 26-417
Epsom
Auckland
2718 0
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Country: New Zealand 2718 0
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Funding Source: Government body 2719 0
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Name: South Australia Premier Science and Research Fund 2719 0
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Address: GPO Box 2343
Adelaide SA 5001
2719 0
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Country: Australia 2719 0
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Funding Source: Charities/Societies/Foundations 2720 0
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Name: Guys and St Thomas' Charity 2720 0
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Address: The Counting House Guy's Hospital
1st Floor
St Thomas St
London SE1 9RT
2720 0
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Country: United Kingdom 2720 0
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Funding Source: Government body 2721 0
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Name: Health Research Board Ireland 2721 0
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Address: 73 Lower Baggot St
Dublin 2
2721 0
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Country: Ireland 2721 0
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Funding Source: University 2722 0
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Name: University of Manchester Proof of Concept Funding UK 2722 0
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Address: University of Manchester
Hathersage Rd
Manchester M13 0JH
2722 0
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Country: United Kingdom 2722 0
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Funding Source: Government body 2723 0
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Name: Biotechnology and Biological Sciences Research Council UK 2723 0
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Address: Polaris House
North Star Ave
Swindon SN2 1UH
2723 0
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Country: United Kingdom 2723 0
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Funding Source: Government body 2724 0
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Name: National Health Services NEAT Grant UK -Grant 2724 0
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Address: National Institute for Health Research
Rm 132
Richmond Hse
79 Whitehall
London SW1A 2NL
2724 0
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Country: United Kingdom 2724 0
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Funding Source: Charities/Societies/Foundations 2725 0
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Name: Tommy's the Baby Charity UK 2725 0
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Address: 109 High Street
Thame
Oxon OX9 3DZ
2725 0
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Country: United Kingdom 2725 0
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Funding Source: Charities/Societies/Foundations 2726 0
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Name: Cerebra 2726 0
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Address: Cerebra
2nd Floor Offices
The Lyric Bldg
King St
Carmarthen SA31 1BD
2726 0
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Country: United Kingdom 2726 0
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Primary Sponsor University
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Name: Associate Professor Robyn North
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Address: SCOPE Study
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1172
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Country: New Zealand
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Secondary Sponsor: University 2462 0
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Name: Associate Professor Lesley McCowan 2462 0
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Address: SCOPE Study
Tamaki Campus
University of Auckland
Private Bag 92019
Auckland 1172
2462 0
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Country: New Zealand 2462 0
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Other Collaborator: University 25 0
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Name: Professor Gustaaf Dekker 25 0
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Address: Discipline of Obstetrics and Gynaecology
University of Adelaide
Lyell McEwen Hospital
Haydown Rd
Elizabeth Vale SA 5112
25 0
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Country: Australia 25 0
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Other Collaborator: University 26 0
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Name: Dr Claire Roberts 26 0
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Address: Discipline of Obstetrics and Gynaecology
University of Adelaide
SA 5005
26 0
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Country: Australia 26 0
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Other Collaborator: University 27 0
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Name: Professor Philip Baker 27 0
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Address: Maternal and Fetal Health Research Unit
University of Manchester
St Mary's Hospital
Whitworth Park M13 0JH
27 0
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Country: United Kingdom 27 0
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Other Collaborator: University 28 0
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Name: Professor Lucilla Poston 28 0
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Address: Maternal and Fatal Research Unit
Division of Reproduction and Endocrinology
King's College London
St Thomas' Hospital
London SE1 7EH
28 0
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Country: United Kingdom 28 0
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Other Collaborator: University 76 0
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Name: Professor Andrew Shennan 76 0
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Address: Maternal and Fatal Research Unit
Division of Reproduction and Endocrinology
King's College London
St Thomas' Hospital
London SE1 7EH
76 0
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Country: United Kingdom 76 0
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Other Collaborator: University 77 0
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Name: Professor James Walker 77 0
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Address: Academic Department of Obstetrics & Gynaecology
University of Leeds
L 9
Gledhow Wing
St James University Hospital
Beckett St
Leeds LS9 7TF
77 0
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Country: United Kingdom 77 0
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Other Collaborator: University 78 0
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Name: Mr Nigel Simpson 78 0
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Address: Academic Department of Obstetrics & Gynaecology
University of Leeds
L 9
Gledhow Wing
St James University Hospital
Beckett St
Leeds LS9 7TF
78 0
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Country: United Kingdom 78 0
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Other Collaborator: University 79 0
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Name: Dr Louise Kenny 79 0
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Address: Department of Obstetrics and Gynaecology
University College Cork
Cork University Maternity Hospital
Wilton
Cork
79 0
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Country: Ireland 79 0
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Page 9

Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Northern X Regional Ethics Committee 4504 0
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Address: Private Bag 92 522
Wellesley St
Auckland
4504 0
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Country: New Zealand 4504 0
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Approval Date: 23/04/2003 4504 0
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Submitted Date: 4504 0
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HREC: AKX/02/00/364 4504 0
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Ethics Committee name: Central Northern Adelaide Health Service, Ethics of Human Research Committee 4505 0
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Address: Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale
Adelaide SA 5112
4505 0
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Country: Australia 4505 0
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Approval Date: 02/09/2005 4505 0
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Submitted Date: 4505 0
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HREC: 2005082 4505 0
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Ethics Committee name: South East Multi-centre Research Ethics Committee St Thomas Hospital Research Ethics Committee 4506 0
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Address: Aylesford
Kent
4506 0
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Country: United Kingdom 4506 0
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Approval Date: 19/01/2007 4506 0
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Submitted Date: 4506 0
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HREC: 06/MRE01/98 4506 0
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Ethics Committee name: South East Multi-centre Research Ethics Committee Central Manchester Research Ethics Committee 4638 0
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Reason:
 
Address: Aylesford
Kent
4638 0
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Country: United Kingdom 4638 0
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Approval Date: 19/01/2007 4638 0
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Submitted Date: 4638 0
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HREC: 06/MRE01/98 4638 0
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Ethics Committee name: Clinical Research Ethics Committee of the Cork Teaching Hospitals 4639 0
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Reason:
 
Address: Secretariat, Clinical Research Ethics Committee of The Cork Teaching Hospitals
1st Floor
Lancaster Hall
6 Little Hanover Street
Cork
4639 0
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Country: Ireland 4639 0
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Approval Date: 4639 0
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Submitted Date: 01/09/2007 4639 0
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HREC: 4639 0
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Brief summary Preeclampsia, spontaneous preterm birth and birth of a small for gestational age (growth restricted) baby are the three major complications of late pregnancy, affecting approximately 19% of first pregnancies. They are a leading cause of maternal morbidity, perinatal morbidity and mortality, neuro-developmental handicap and lifelong health consequences. There are a number of clinical risk factors and biomarkers for these diseases, but currently there are no predictive tests for these conditions. Although no single clinical risk factor or biomarker is a useful predictor, novel combinations of clinical risk factors and/or biomarkers are likely to perform as reliable screening tests for these conditions.
The primary aim of SCOPE is to produce clinically useful screening tests based on 1) clinical risk factors, 2) biomarkers and 3) a combination of clinical risk factors and biomarkers to detect first time mothers at high risk of preeclampsia, spontaneous preterm birth and/or small for gestational age babies.
If successful, this will allow individualised tailoring of antenatal care for future first time mothers and where appropriate, intervention to prevent these conditions. This will empower women and their clinicians to make informed decisions about their care in pregnancy, thereby optimizing the health of mothers and babies.
The first generation of predictive tests based on clinical risk factors and biomarkers alone or in combination with clinical risk factors will be developed in the first 2500 women recruited into SCOPE. The total sample size for further testing and validation is estimated at 10,000.
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Trial website www.scopestudy.net,
www.maps-study.net
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Trial related presentations / publications nil
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Public Notes
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Page 10

Principal Investigator
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Contact person for public queries
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Name: Associate Professor Lesley McCowan
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Address: School of Population Health Faculty of Medical and Health Science University of Auckland Tamaki Campus Private Bag 92019 Auckland
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Country: New Zealand
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11180 0
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Tel: +64 9 3737599 ext. 89192
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Fax: +64 9 3737624
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Email: l.mccowan@auckland.ac.nz
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Contact person for scientific queries
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Name: Associate Professor Robyn North
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2108 0
Address: Department of Obstetrics and Gynaecology School of Population Health Faculty of Medical and Health Science University of Auckland Tamaki Campus Private Bag 92019 Auckland
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2108 0
Country: New Zealand
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2108 0
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Tel: +64 9 3737599 ext. 89183
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2108 0
Fax: +64 9 3737624
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2108 0
Email: r.north@auckland.ac.nz
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Contact person responsible for updating information
Title:
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Name: Rennae Taylor
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Address: Department of Obstetrics and Gynaecology School of Population Health Faculty of Medical and Health Science University of Auckland Tamaki Campus Private Bag 92019 Auckland
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Country: New Zealand
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Tel: +64 9 3737599 ext. 89186
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Fax: +64 9 3737624
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Email: r.taylor@auckland.ac.nz
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Addition Cancer fields
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