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ISRCTN
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ISRCTN00582888
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ClinicalTrials.gov identifier
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Public title
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Two studies of blood pressure (BP) elevation associated with pregnancy and the oral contraceptive
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0241048443
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Study hypothesis
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1. Do combined oral contraceptives (COC) exert a differential effect on the blood pressures (BP) of women with and without a past history of BP elevation in pregnancy?
2. Do oral progestrogen only contraceptives produce a significant elevation of BP in women who have had COC induced hypertension?
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular: Hypertension
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Participants - inclusion criteria
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Study 1 - 25 women who have developed significant BP elevation and 25 who have never suffered raised BP during pregnancy.
Study 2 - 50 women with a history of raised BP in association with taking oral contraceptive.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/08/2000
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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75
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Interventions
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Study 1 (controlled trial):
25 women who have developed significant BP elevation during pregnancy and 25 who have never suffered raised BP during pregnancy will receive combined oral contraceptives.
Study 2 (randomised controlled trial):
50 women with a history of raised BP in association with taking oral contraceptives will be randomised to receive a progestrogen-only contraceptive versus a placebo.
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Primary outcome measure(s)
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First in a series of collaborative studies between CVSU, Obs & Gynae and Vascular Biology (Clin Pharm).
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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St Mary's NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Prof
Neil
Poulter
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Address
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Clinical Pharmacology
Cardiovascular Studies Unit
St Mary's Hospital
Praed Street
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City/town
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London
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Zip/Postcode
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W2 1NY
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Country
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United Kingdom
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Tel
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+44 (0)20 7594 3445
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Email
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n.poulter@ic.ac.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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22/04/2008
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Date ISRCTN assigned
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12/09/2003
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