Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies (CAREFOL-HT)
Pre-Eclampsia, Pregnancy Induced Hypertension, Pregnancy Related
About this trial
This is an interventional basic science trial for Pre-Eclampsia focused on measuring 5-methyltetrahydrofolate, Tetrahydrobiopterin, Pre-Eclampsia, Antenatal study
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
Sites / Locations
- Oxford University Hospitals NHS Foundation TrustRecruiting
- Cardiovascular Clinical Research FacilityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
No Intervention
Placebo Comparator
Active Comparator
Active Comparator
Normotensive
Preeclampsia - Placebo
Preeclampsia - low dosage
Preeclampsia - high dosage
A sub-cohort of 32 normotensive women will be recruited to establish normal pregnancy values for the measures performed as well as validation of outcome measures.
A sub-cohort of 32 preeclampsia women will be recruited taking the placebo.
A sub-cohort of 32 preeclampsia women will be recruited taking the placebo low dose of 5-MTHF.
A sub-cohort of 32 preeclampsia women will be recruited taking the placebo high dose of 5-MTHF.