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Clinical Antenatal Randomised Study to CharactErise Key Roles of TetrahydroFOLate in HyperTensive Pregnancies (CAREFOL-HT)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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. Previous studies have revealed detrimental changes in the structure and function of the heart and blood vessels of mothers, and their babies, who experience this common complication. These changes may explain their increased risk of later disease. The investigators have also learned through previous studies that tetrahydrobiopterin (BH4), a molecule that has a role in blood vessel health, plays an important role in stabilising blood vessel function. Lower levels of BH4 are evident in both the placenta and the umbilical cord from mothers with high blood pressure. We, therefore, want to investigate how closely BH4 levels are related to clinical features of pre-eclampsia and whether altering levels of BH4, using a nutritional supplement, improves features of the disease such as blood vessel function. To do this, the investigators need to compare the levels of BH4 between mothers with pre-eclampsia, those taking the supplement and those without pre-eclampsia. The investigators also compare how the heart and blood vessels look and function in these groups using ultrasound methods, including echocardiography and fetal sonography. Study objectives CAREFOL-HT will assess how levels of BH4 differ in pregnant women with high blood pressure and if this is reflected in functional changes in the heart and blood vessels of these women. The investigators will also determine whether changing levels of BH4, using a tetrahydrofolate supplement (5-MTHF), changes blood vessel function.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
United Kingdom
Cardiovascular Clinical Research Facility
RECRUITING
Oxford
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Contact Information
Primary
Annabelle Frost, MD
carefol-ht@cardiov.ox.ac.uk
01865 572833
Backup
Cheryl Tan, MRes
cheryl-mj.tan@cardiov.ox.ac.uk
01865 572833
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 128
Treatments
No_intervention: Normotensive
A sub-cohort of 32 normotensive women will be recruited to establish normal pregnancy values for the measures performed as well as validation of outcome measures.
Placebo_comparator: Preeclampsia - Placebo
A sub-cohort of 32 preeclampsia women will be recruited taking the placebo.
Active_comparator: Preeclampsia - low dosage
A sub-cohort of 32 preeclampsia women will be recruited taking the placebo low dose of 5-MTHF.
Active_comparator: Preeclampsia - high dosage
A sub-cohort of 32 preeclampsia women will be recruited taking the placebo high dose of 5-MTHF.
Related Therapeutic Areas
Sponsors
Leads: University of Oxford
Collaborators: Merck & Cie, British Heart Foundation, National Institute for Health Research, United Kingdom

This content was sourced from clinicaltrials.gov