Status:
UNKNOWN
Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
British Heart Foundation
Conditions:
Pre-Eclampsia
Pregnancy Induced Hypertension
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 eviden...
Detailed Description
High blood pressure during pregnancy is a world-wide health problem that can be dangerous to mothers, and commonly causes premature birth and small babies. There is also growing evidence that mothers ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05434195
Start Date
June 1 2021
End Date
June 1 2024
Last Update
June 27 2022
Active Locations (2)
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1
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordhsire, United Kingdom, OX3 9DU
2
Cardiovascular Clinical Research Facility
Oxford, Oxfordshire, United Kingdom, OX3 7RD