Dark chocolate in pregnancy study
| ISRCTN | ISRCTN41164968 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41164968 |
| Secondary identifying numbers | RCT0076-3 |
- Submission date
- 12/12/2011
- Registration date
- 18/01/2012
- Last edited
- 18/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Stephen Robson
Scientific
Scientific
John James Medical Centre
175 Strickland Crescent
Deakin
2605
Australia
| Phone | +61 2 6282 3033 |
|---|---|
| stephen.robson@anu.edu.au |
Study information
| Study design | A randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial of dark chocolate in pregnancy for reduction in incidence of pre-eclampsia |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Diagnosis of pre-eclampsia by seven days post-delivery |
| Secondary outcome measures | 1. Gestational diabetes 2. Birthweight percentile |
| Overall study start date | 01/04/2012 |
| Completion date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 800 |
| Key inclusion criteria | Primigravid women who are enrolled prior to 10 completed weeks of gestation |
| Key exclusion criteria | 1. Pre-existing hypertension 2. Pre-existing diabetes |
| Date of first enrolment | 01/04/2012 |
| Date of final enrolment | 30/06/2013 |
Locations
Countries of recruitment
- Australia
Study participating centre
John James Medical Centre
Deakin
2605
Australia
2605
Australia
Sponsor information
James Cook University (Australia)
University/education
University/education
c/o Ms Cindy Woods
P.O. Box 6811
Cairns
QLD 4870
Australia
| Website | http://www.jcu.edu.au |
|---|---|
"ROR" |
https://ror.org/04gsp2c11 |
Funders
Funder type
Other
Investigator initiated and funded
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
