Subclinical Postpartum Renal Structure After Hypertensive Pregnancy Disorders.
Hannah R Cutler, Jamie Kitt, Prenali D Sattwika...
https://pubmed.ncbi.nlm.nih.gov/40886083Actively Recruiting
Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID05434195
Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies (CAREFOL-HT)
Led by University of Oxford · Updated on 2026-04-29
128
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
N
National Institute for Health Research, United Kingdom
Collaborating Sponsor
AI-Summary
What this Trial Is About
High blood pressure during pregnancy, including conditions like preeclampsia, is a common global health issue that can be harmful to mothers and often leads to premature birth and small babies. This condition also increases the risk of cardiovascular problems later in life for both mothers and their children. Researchers are studying how levels of a molecule called tetrahydrobiopterin (BH4), important for blood vessel health, differ in pregnant women with high blood pressure and how these changes affect heart and blood vessel function in both mothers and babies. The study involves pregnant women with high blood pressure, who will receive either a low or high dose of a tetrahydrofolate supplement (5-MTHF), which is a biologically active form of reduced folate thought to increase BH4 levels. Another group of women with high blood pressure will receive a placebo, while a comparison group of women with normal blood pressure will not receive any supplement. This treatment will continue until delivery, and samples such as blood, umbilical cord, and placenta will be collected for analysis. Participants will have assessments of heart and blood vessel function using ultrasound methods at the start of the study (around 28 to 34 weeks of pregnancy) and at delivery. Blood tests will measure BH4 and related biomarkers in mothers and babies. The study will also evaluate the safety and acceptability of the supplementation through questionnaires. Total participation includes monitoring during pregnancy until birth, with careful analysis of vascular and cardiac changes.
CONDITIONS
Brief Title
Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies
Who Can Participate
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Diagnosed with preeclampsia before 34 weeks' gestation within the last 48 hours with no delivery planned within the next week
- Receiving antenatal care at the study hospital
- Willing and able to give informed consent
- Female aged over 18 and up to 45 years
- Normotensive women with blood pressures below 140/90 and low risk factors for hypertensive disease (for control group)
You will not qualify if you...
- History of serious heart problems such as uncontrolled arrhythmia or heart failure
- Preexisting chronic kidney disease
- Contraindications to folate supplements
- Taking folate supplements exceeding 400mcg in the third trimester
- Low vitamin B12 levels
- Use of proton pump inhibitors or anti-epileptic drugs
- Known fetal trisomy or congenital heart defects
- Fetus at high risk of heart disease or known infection
- Known severe anemia
- Diagnosis of hypertensive disorder in normotensive group
- Use of beta blockers like atenolol in normotensive group
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From enrollment until delivery (approximately 28 to 34 weeks gestation to delivery)
Participants with high blood pressure in pregnancy take either a low dose, high dose of a biologically-active tetrahydrofolate supplement, or placebo until delivery. Normotensive participants are observed without supplementation.
2 visits (one at baseline and one at delivery)
Sample Collection
Duration - At baseline and at delivery
Blood tests and measurements are performed on mothers and babies at baseline and delivery. Umbilical cord and placenta tissue samples are collected at delivery for laboratory studies.
2 visits (one at baseline and one at delivery)
Trial Site Locations
Total: 2 locations
1
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordhsire, United Kingdom, OX3 9DU
Actively Recruiting
2
Cardiovascular Clinical Research Facility
Oxford, Oxfordshire, United Kingdom, OX3 7RD
Actively Recruiting
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Research Team
A
Annabelle Frost, MD
C
Cheryl Tan, MRes
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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