Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Stephen Robson
ORCID ID
Contact details
John James Medical Centre
175 Strickland Crescent
Deakin
2605
Australia
+61 2 6282 3033
stephen.robson@anu.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RCT0076-3
Study information
Scientific title
A randomised controlled trial of dark chocolate in pregnancy for reduction in incidence of pre-eclampsia
Acronym
Study hypothesis
That daily dark chocolate (>70% cocoa) from 10 to 32 weeks of gestation reduces the incidence of pre-eclampsia compared to no chocolate
Ethics approval
Not provided at time of registration
Study design
A randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pre-eclampsia
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Diagnosis of pre-eclampsia by seven days post-delivery
Secondary outcome measures
1. Gestational diabetes
2. Birthweight percentile
Overall trial start date
01/04/2012
Overall trial end date
30/06/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Primigravid women who are enrolled prior to 10 completed weeks of gestation
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
800
Participant exclusion criteria
1. Pre-existing hypertension
2. Pre-existing diabetes
Recruitment start date
01/04/2012
Recruitment end date
30/06/2013
Locations
Countries of recruitment
Australia
Trial participating centre
John James Medical Centre
Deakin
2605
Australia
Sponsor information
Organisation
James Cook University (Australia)
Sponsor details
c/o Ms Cindy Woods
P.O. Box 6811
Cairns
QLD 4870
Australia
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary