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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Max
Hughes
+44 (0)121 414 7023
cape@trials.bham.ac.uk
Dr
Shireen
Meher
+44 (0)121 4721377
smeher@nhs.net
More information about this study, what is involved and how to take part can be found on the study website.
Prevention of pre-eclampsia in women at increased risk
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Pre-eclampsia affects around one in 30 pregnancies in the UK. It usually presents with high blood pressure and protein in the urine but may also affect other organs in the body. While most women have a good outcome, the complications of pre-eclampsia can make women very unwell, and include fits and bleeding. The baby may also be affected by reduced growth and being born too early. In severe cases, the mother or baby may even die. The impact of the disease on women and their families is often considerable, related to the effect on their wellbeing as well as needing additional tests, admission to hospital and early delivery. This is also costly for the NHS.
At present doctors use aspirin to prevent pre-eclampsia in women who are more likely to develop it, but it only reduces the chance of getting pre-eclampsia by 10-20%. Delivery is the only cure.
Previous studies suggest calcium may be beneficial for preventing pre-eclampsia. However, most 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. Moreover, little research has focused on the impact of calcium on women at high risk of pre-eclampsia.
This study will assess whether calcium supplementation during pregnancy along with usual antenatal care (including aspirin) is more effective than usual antenatal care alone in reducing the risk of pre-eclampsia in women who are at high risk.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Any known contraindications to regular calcium intake (history of renal stones, known renal impairment with pre-pregnancy eGFR <30 ml/min/1.73m² or serum creatinine >150 (μmol/l), known history of hypercalcaemia or hypercalcaemia-causing diseases (e.g. parathyroid disease, sarcoidosis, malignancy), current severe persistent vomiting leading to dehydration or requiring hospitalisation (if persisting vomiting resolves, the patient may be re-assessed for inclusion in the trial, providing all other inclusion and exclusion criteria are met)2. Use of drugs with potential for severe interactions with calcium: digoxin or other cardiac glycosides; antiretroviral drugs for HIV treatment, anti-neoplastic drugs, and diuretics (thiazide, thiazide-like or xipamide). 3. Use of any additional calcium supplement either on its own or as part of other multivitamin or Vitamin D preparations, and unwilling to stop them or change to other multivitamins, as this could lead to higher doses of calcium supplementation in the calcium group and contamination in the placebo group4. Women who are taking vitamin D regularly in high doses >1000 IU/day, as supplements or for conditions such as malabsorption syndromes. Note: a short course of high dose Vitamin D (e.g., 20,000 IU weekly for 6 weeks) to treat Vitamin D deficiency during pregnancy is NOT an exclusion criteria5. Known contraindications to excipient Isomalt (e.g. hereditary fructose intolerance)
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Max
Hughes
+44 (0)121 414 7023
cape@trials.bham.ac.uk
Dr
Shireen
Meher
+44 (0)121 4721377
smeher@nhs.net
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham and funded by Health Technology Assessment Programme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 42555
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
