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New treatment option for Pre-Eclampsia
Official title Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies
ClinicalTrials.gov ID: NCT05434195
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- (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...
- 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
You likely can't join if
- (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)
See the full eligibility 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
- (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
The study team makes the final eligibility decision.
Where it's taking place
- Oxford, Oxfordhsire, United Kingdom
- Oxford, Oxfordshire, United Kingdom
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oxford, Oxfordhsire, United Kingdom; Oxford, Oxfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.