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ISRCTN
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ISRCTN41164968
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ClinicalTrials.gov identifier
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Public title
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Dark chocolate in pregnancy study
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Scientific title
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A randomised controlled trial of dark chocolate in pregnancy for reduction in incidence of pre-eclampsia
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Acronym
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N/A
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Serial number at source
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RCT0076-3
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Study hypothesis
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That daily dark chocolate (>70% cocoa) from 10 to 32 weeks of gestation reduces the incidence of pre-eclampsia compared to no chocolate
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Lay summary
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Not provided at time of registration
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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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A randomised controlled trial
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Countries of recruitment
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Australia
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Disease/condition/study domain
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Pre-eclampsia
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Participants - inclusion criteria
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Primigravid women who are enrolled prior to 10 completed weeks of gestation
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Participants - exclusion criteria
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1. Pre-existing hypertension
2. Pre-existing diabetes
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Anticipated start date
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01/04/2012
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Anticipated end date
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30/06/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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800
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Interventions
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Women are recruited in very early pregnancy, and the study group takes 20 grams of 70% dark chocolate daily from 10 to 32 weeks.
Control group just keeps a food diary.
Follow-up continues until 7 days post-partum.
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Primary outcome measure(s)
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Diagnosis of pre-eclampsia by seven days post-delivery
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Secondary outcome measure(s)
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1. Gestational diabetes
2. Birthweight percentile
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Sources of funding
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Investigator initiated and funded
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Trial website
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http://www.chocolatestudy.net
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Publications
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Contact name
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Dr
Stephen
Robson
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Address
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John James Medical Centre
175 Strickland Crescent
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City/town
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Deakin
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Zip/Postcode
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2605
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Country
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Australia
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Tel
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+61 2 6282 3033
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Email
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stephen.robson@anu.edu.au
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Sponsor
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James Cook University (Australia)
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Address
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c/o Ms Cindy Woods
P.O. Box 6811
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City/town
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Cairns
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Zip/Postcode
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QLD 4870
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Country
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Australia
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Sponsor website:
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http://www.jcu.edu.au
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Date applied
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12/12/2011
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Last edited
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18/01/2012
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Date ISRCTN assigned
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18/01/2012
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