CaPE - Calcium for prevention of pre-eclampsia in high-risk women
Research type
Research Study
Full title
Calcium Supplementation for Prevention of Pre-eclampsia in High Risk Women: CaPE Trial
IRAS ID
262719
Contact name
Shireen MEHER
Contact email
Sponsor organisation
Univeristy of Birmingham
Eudract number
2020-004435-25
ISRCTN Number
ISRCTN12033893
Duration of Study in the UK
4 years, 5 months, 30 days
Research summary
Pre-eclampsia affects one in 30 pregnancies in the UK, and usually presents with high blood pressure and protein in the urine. Complications of pre-eclampsia can make women very unwell and the baby may also have reduced growth, be born too early or even die. Women may need additional tests and hospital admission. This is also costly for the NHS. Currently, aspirin is used to reduce the risk of pre-eclampsia but it only has modest benefits. Delivery is the only cure.
Calcium may be beneficial for preventing pre-eclampsia but most previous studies have been conducted in populations with low dietary calcium intake, so findings have not been viewed as applicable to a population with adequate calcium intake, such as in the UK. Little research has focused on the impact of calcium on high risk women.
CaPE is a randomised, blinded, placebo controlled multicentre trial to assess the clinical and cost-effectiveness of oral calcium supplementation of 2 grams per day taken from 12 to 22 weeks’ gestation until delivery plus usual care (including aspirin) compared with usual care alone in reducing the risk of pre-eclampsia and its complications in women at high risk of developing pre-eclampsia.
7756 women at high risk of developing pre-eclampsia will be recruited from around 40 maternity units across the UK.
The primary outcome is the incidence of pre-eclampsia and secondary outcomes include other important outcomes for the mother and baby. We will also assess how well women are able to take the trial medication and whether particular groups of women benefit more than others. A health economics evaluation will be undertaken to determine the cost-effectiveness of calcium.
Timelines: six month set up, with 12 month internal pilot; main trial: further 22 months of recruitment; 8 months closing down for data collection, 6 months of analysis and reporting (total 4.5 years).
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0281
Date of REC Opinion
12 Jan 2022
REC opinion
Further Information Favourable Opinion