Testing a form of folate in pregnancy for women with high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Women with pre-eclampsia or pregnancy-induced hypertension before 34 weeks who are receiving antenatal care at the John Radcliffe Hospital are randomly assigned to receive either Arcofolin® (5‑methyltetrahydrofolate) or placebo. The study measures levels of tetrahydrobiopterin (BH4) in maternal and placental tissues and monitors cardiovascular and pregnancy-related outcomes for mother and baby. The design compares biological markers and clinical outcomes between the two groups to see if the active folate restores BH4 and improves blood vessel function. Participants are followed through the antenatal period with safety monitoring and standard obstetric care.

Why it matters

Who can join: the full rules

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

Where it's running

• Oxford University Hospitals NHS Foundation Trust
  Oxford, Oxfordhsire, United Kingdom Recruiting
• Cardiovascular Clinical Research Facility
  Oxford, Oxfordshire, United Kingdom Recruiting

Study contacts

• Principal investigator: Paul Leeson, FRCP — University of Oxford, John Radcliffe Hospital
• Study coordinator: Annabelle Frost, MD
• Email: carefol-ht@cardiov.ox.ac.uk
• Phone: 01865 572833

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.