Effects of Dietary Nitrate in Hypertensive Pregnant Women

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility Study on the Effects of Dietary Nitrate on Cardiovascular Function in Hypertensive Pregnant Women

Conditions
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Hypertension, Pregnancy

Intervention / Treatment
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* Dietary Supplement: Beetroot juice
* Dietary Supplement: Nitrate-depleted beetroot juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary nitrate, beetroot juice<br>Once daily 70mL dose of beetroot juice, containing 400mg inorganic nitrate, for 7 consecutive days. | Dietary Supplement: Beetroot juice<br>* 200mls daily for seven days<br>|
| Placebo Comparator: Nitrate-depleted beetroot juice<br>Once daily 70mL dose of beetroot juice, depleted of nitrate, for 7 consecutive days. | Dietary Supplement: Nitrate-depleted beetroot juice<br>* 200mls daily for seven days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) |