Dark chocolate in pregnancy study
| ISRCTN | ISRCTN41164968 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41164968 |
| Protocol serial number | RCT0076-3 |
| Sponsor | James Cook University (Australia) |
| Funder | Investigator initiated and funded |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | A randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Diagnosis of pre-eclampsia by seven days post-delivery |
| Key secondary outcome measure(s) |
1. Gestational diabetes |
| Completion date | 30/06/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
