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Could a simple vitamin help pregnant women with high blood pressure?

NCT ID NCT05434195

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether a special form of folic acid (5-MTHF) can improve blood vessel health in pregnant women with high blood pressure or pre-eclampsia. Researchers will measure key molecules in the blood, placenta, and umbilical cord to see if the supplement helps. The trial involves 128 women and aims to understand how the supplement affects the body, not to cure the condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
5-methyltetrahydrofolate (a form of folic acid)
What this could lead to
If it works, this could point toward a simple nutritional supplement to help manage high blood pressure in pregnancy and protect the heart health of mothers and their babies.
What could go wrong
This is a small, early-stage study focused on measuring biological markers, not on preventing or curing the condition. The supplement may not lead to clear health improvements, and results may not apply to all pregnant women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cardiovascular Clinical Research Facility

    RECRUITING

    Oxford, Oxfordshire, OX3 7RD, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    RECRUITING

    Oxford, Oxfordhsire, OX3 9DU, United Kingdom

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