This is a randomised placebo controlled trial investigating the effects of dietary nitrate supplementation on hypertension in pregnancy
Reduced nitrate and nitrite concentrations have been found in women with preeclampsia (PE) and studies have shown increased concentrations of an endogenously generated Nitric Oxide Synthase inhibitor, amongst women with PE. Nitrate and nitrite are required to produce Nitric Oxide (NO). NO is released from the endothelial lining of blood vessels, and acts to relax smooth muscle within the vasculature, acting as a potent vasodilator. Reduced NO concentrations are hence thought to contribute towards the systemic vascular constriction seen in PE. Hypertensive diseases in pregnancy are an important cause of morbidity and mortality in both maternal, fetal and neonatal health. Treatment options are limited in pregnancy and hence alternative methods to improve blood pressure control should be sought. In this randomised placebo controlled double blinded trial we aim to assess the effect of dietary nitrate supplementation on the hypertensive diseases of pregnancy and the subsequent maternal, fetal-neonatal outcomes. The safety and acceptability of dietary nitrate supplementation will also be confirmed in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
320
70mL concentrated beetroot juice (400mg nitrate)
70mL concentrated nitrate deplete beetroot juice (\<0.01mmol/L nitrate)
King's College Hospital
London, United Kingdom
RECRUITINGGestational age of delivery secondary to preeclampsia
Time frame: From recruitment until delivery
Gestational age of delivery (due to any cause)
Time frame: From recruitment until delivery
Will beetroot juice supplementation increase or decrease the likelihood of maternal complications, including severe maternal complications
Time frame: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation increase or decrease the likelihood of severe hypertension
Defined as ≥ 160/110 mmHg
Time frame: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation result in significant changes in systolic blood pressure and diastolic blood pressure
Time frame: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation result in a significant change in the maximal number and dosages of antihypertensive medications required for blood pressure control
Time frame: From recruitment until 8 weeks postnatal
Will beetroot juice supplementation result in a significant change in maternal blood values and urinary protein excretion
Measured by creatinine, aspartate aminotransferase, alanine aminotransferase, uric acid, platelets, random urine protein creatinine ratio, protein concentration in a 24hour urine collection
Time frame: From recruitment until 8 weeks postnatal
Can the safety of beetroot juice supplementation in pregnancy be confirmed
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Measurement of maternal methemoglobinaemia levels, maternal nitrosamine levels, maternal thyroid function, neonatal cord bloods, neonatal methemoglobinaemia levels
Time frame: From recruitment until 8 weeks postnatal
To confirm the acceptability of beetroot juice supplementation in pregnancy
A post-trial questionnaire
Time frame: At 8 weeks postnatal