Hypertension, Pregnancy
Conditions
Brief summary
High blood pressure in pregnancy affects around 10% of pregnancies, and is associated with serious adverse outcomes for both mother and baby. Treatment options for the management of high blood pressure in pregnancy are currently limited. Studies in non-pregnant individuals have shown that supplementation with dietary nitrate, using beetroot juice, can significantly lower blood pressure and improve blood flow. This study aims to investigate whether supplementation with dietary nitrate (via beetroot juice) can improve blood pressure regulation in pregnant women with chronic high blood pressure, and will also determine whether this can improve blood flow across the placenta.
Interventions
DIETARY_SUPPLEMENTBeetroot juice
70mls daily for seven days
DIETARY_SUPPLEMENTNitrate-depleted beetroot juice
70mls daily for seven days
Sponsors
University of Manchester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Dietary Nitrate
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women diagnosed with chronic hypertension (systolic blood pressure of 130-144 mmHg and/or diastolic blood pressure of 80-94 mmHg). * Between 22 - 35+6 weeks gestation
Exclusion criteria
* Multi-fetal pregnancy * Currently taking anti-hypertensive medication * Pre-existing diabetes (Type 1 or Type 2) * Lacking ability to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in clinic blood pressure (compared to baseline) between treatment and placebo groups | The outcome will be determined after 7 days treatment (compared to baseline) |
Secondary
| Measure | Time frame |
|---|---|
| Recruitment rates | Across study (18 months) |
| Uterine artery blood flow (compared to baseline) | The outcome will be determined after 7 days treatment (compared to baseline) |
| Umbilical artery blood flow (compared to baseline) | The outcome will be determined after 7 days treatment (compared to baseline) |
| Changes in plasma and salivary nitrate concentrations | The outcome will be determined after 7 days treatment (compared to baseline) |
| Changes in plasma and salivary nitrite concentrations | The outcome will be determined after 7 days treatment (compared to baseline) |
Countries
United Kingdom
Outcome results
None listed