We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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
Casey
Johnson
casey.johnson@cardiov.ox.ac.uk
Study
Team
clinicalresearch@cardiov.ox.ac.uk
Dr
Annabelle
Frost
Annabelle.frost@cardiov.ox.ac.uk
Study
Team
clinicalresearch@cardiov.ox.ac.uk
Mr
Casey
Johnson
casey.johnson@cardiov.ox.ac.uk
Prof
Paul
Leeson
paul.leeson@cardiov.ox.ac.uk
Oedema, proteinuria and hypertensive disorders in pregnancy, childbirth and the puerperium
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. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Previous research has shown certain biological processes may be disturbed in women with high blood pressure in pregnancy. One of these processes involves a molecule called tetrahydrobiopterin (BH4) which is required for the correct functioning of blood vessels. We have seen lower levels of BH4 in both the placenta and the umbilical cord from mothers with high blood pressure as well as lower levels of BH4 in pregnant mice affected by high blood pressure. In both mice and human umbilical vein cells, increasing the level of BH4 using a nutritional supplement 5-methyltetrahydrofolate (5-MTHF), reversed the effects of the condition. The purpose of this study is to find out if circulating BH4, plays a role in humans affected by preeclampsia and if its blood levels are associated with changes in the structure and function of the heart and blood vessels in both mother and baby. We plan to investigate the levels of BH4 by performing a single site, double blinded randomised controlled trial. Women with severe preeclampsia will be recruited and levels of BH4 will be changed by oral supplementation of either 5-MTHF(low dose or high dose) or placebo. A group of women without blood pressure complications in pregnancy will also be recruited to provide validation to the study measurements. In all women, we will measure blood levels of BH4 and other molecules involved in the pathway of blood vessel function at two time points, prior to supplementation and just before delivery. We will also measure heart and blood vessel function in both mother and baby. After delivery, we will collect the umbilical cord and placental tissue to assess blood vessel cell function in the baby and the impact of changing levels of BH4 in the mother.
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:
Interventional type: Dietary;Cellular;
You can take part if:
You may not be able to take part if:
Women with PE • Participants with significant disease or medical disorders, which, in the opinion of the Investigator, may either, put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. • Participants who are deemed unsafe for folate supplementation due to a previous allergic reaction or potential interactions with current medications • Participants with significant kidney, liver, brain or blood impairment which can be seen in severe preeclampsia • Participants whose babies have known heart conditions or are at a high risk of a heart complication Women without PE • Participants with significant disease or medical disorders which in the opinion of the Investigator may influence the results of the trial or the participants ability to participate in the trial • Participants whose babies have known heart conditions or are at a high risk of a heart complication
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Casey
Johnson
casey.johnson@cardiov.ox.ac.uk
Prof
Paul
Leeson
paul.leeson@cardiov.ox.ac.uk
Study
Team
clinicalresearch@cardiov.ox.ac.uk
Study
Team
clinicalresearch@cardiov.ox.ac.uk
Mr
Casey
Johnson
casey.johnson@cardiov.ox.ac.uk
Dr
Annabelle
Frost
Annabelle.frost@cardiov.ox.ac.uk
The study is sponsored by University of Oxford and funded by BRITISH HEART FOUNDATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 49412
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
