Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies

Launched by UNIVERSITY OF OXFORD · Jun 22, 2022

Keywords

ClinConnect Summary

High blood pressure during pregnancy is a world-wide health problem that can be dangerous to mothers, and commonly causes premature birth and small babies. There is also growing evidence that mothers who suffer from high blood pressure in pregnancy and their babies both have a higher risk of high blood pressure and cardiovascular disease in later life. Previous studies have revealed detrimental changes in the structure and function of the heart and blood vessels of mothers and their babies who experience this common complication which may be important in understanding the subsequent increas...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria (Preeclampsia individuals):
• • Diagnosed with preeclampsia, as defined in Section 8.1, at \<34 weeks' gestation within the last 48 hours and with no delivery planned within the next week
• • Receiving antenatal care in the John Radcliffe Hospital
• • Participant is willing and able to give informed consent for participation in the study
• • Age \>18 and ≤45 years
• Exclusion Criteria (Preeclampsia individuals):
• The participant may not enter the study if ANY of the following apply:
• • Maternal
• • History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease
• • History of preexisting chronic renal disease
• • Contraindication to taking folate related supplements
• • Folate supplementation in excess of 400mcg in the third trimester
• • Low vitamin B12 levels (\<148 pmol/L)
• • Intake of either proton pump inhibitors or anti-epileptic drugs
• • Organ dysfunction Fetal
• • Any known trisomy
• • Fetus with congenital heart defect
• • Fetus at a high risk of heart disease
• • Known infection of fetus
• • Known severe anaemia
• Inclusion Criteria (Normotensive individuals):
• • Participant is willing and able to give informed consent for participation in the study
• • Age \>18 and ≤45 years
• • Normotensive, blood pressures \<140/90 throughout antenatal period
• • Less than 2 moderate risk factors for hypertensive disease in pregnancy according to the NICE guideline for management of hypertension in pregnancy
• • SFlt/PIGF ratio \<35
• Exclusion Criteria (Normotensive individuals):
• The participant may not enter the study if ANY of the following apply:
• • Maternal
• • Diagnosis of hypertensive disorder of pregnancy
• • Use of beta blockers such as atenolol or equivalent
• • History of cardiac impairments including uncontrolled arrhythmia, unstable angina, decompensated congestive heart failure or valve disease
• • History of preexisting chronic renal disease Fetal
• • Any known trisomy
• • Fetus with congenital heart defect
• • Fetus at a high risk of heart disease
• • Known infection of fetus
• • Known severe anaemia