Condition category
Pregnancy and Childbirth
Date applied
12/12/2011
Date assigned
18/01/2012
Last edited
18/01/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.chocolatestudy.net

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

http://www.jcu.edu.au

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

Publication citations

Additional files

Editorial Notes