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RECRUITING

NCT05434195

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

Sponsor: University of Oxford

View on ClinicalTrials.gov

Summary

Study background High blood pressure during pregnancy is a worldwide 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, have a higher risk of high blood pressure and cardiovascular disease later in 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. These changes may explain their increased risk of later disease. The investigators have also learned through previous studies that tetrahydrobiopterin (BH4), a molecule that has a role in blood vessel health, plays an important role in stabilising blood vessel function. Lower levels of BH4 are evident in both the placenta and the umbilical cord from mothers with high blood pressure. We, therefore, want to investigate how closely BH4 levels are related to clinical features of pre-eclampsia and whether altering levels of BH4, using a nutritional supplement, improves features of the disease such as blood vessel function. To do this, the investigators need to compare the levels of BH4 between mothers with pre-eclampsia, those taking the supplement and those without pre-eclampsia. The investigators also compare how the heart and blood vessels look and function in these groups using ultrasound methods, including echocardiography and fetal sonography. Study objectives CAREFOL-HT will assess how levels of BH4 differ in pregnant women with high blood pressure and if this is reflected in functional changes in the heart and blood vessels of these women. The investigators will also determine whether changing levels of BH4, using a tetrahydrofolate supplement (5-MTHF), changes blood vessel function.

Official title: Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies (CAREFOL-HT)

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2021-06-01

Completion Date

2026-10

Last Updated

2026-04-29

Healthy Volunteers

Yes

Conditions

Pre-Eclampsia Pregnancy Induced Hypertension Pregnancy Related

Interventions

DIETARY_SUPPLEMENT

Arcofolin® 5-Methyltetrahydrofolate

5-methyltetrahydrofolate (5-MTHF) is the biologically active form of reduced folate, which can increase BH4 availability. 5-MTHF is available as a nutritional vitamin (Merck \& Cie) for human use including during pregnancy. Two out of three preeclamptic study groups will receive 5-MTHF - one at a low dose and the other at a high dose.

DIETARY_SUPPLEMENT

Arcofolin® Placebo

The placebo, this consists of the same excipients as 5-MTHF, microcrystalline cellulose and silica with no active ingredient.

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

Locations (2)

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordhsire, United Kingdom

Cardiovascular Clinical Research Facility

Oxford, Oxfordshire, United Kingdom