The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy
The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy
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.
Inclusion Criteria:

 -  Aged ≥18

 -  Able to give written informed consent

 -  Singleton pregnancies, between 24+0 to 36+6 weeks gestation with new onset gestational
 hypertension (defined by ISSHP2018 as new onset BP >140/90 and no evidence of
 proteinuria, biochemical or haematological abnormalities or fetal growth restriction)
 Or

 -  Singleton pregnancies, between 24+0 - 36+6 weeks gestation, with chronic hypertension
 (defined by ISSHP2018 as BP ≥140/90 predating the pregnancy or recognised at <20
 week's gestation) Or

 -  Singleton pregnancies, between 24+0 - 36+6 weeks gestation, with preeclampsia (defined
 by ISSHP2018 as Gestational hypertension accompanied by ≥ 1 of the following new onset
 conditions at or after 20 weeks' gestation:

 -  Proteinuria (24h urine collection>300mg/day, Protein-creatinine ratio>30 mg/mmol)

 -  Other markers of maternal organ dysfunction, including:

 -  Acute Kidney Injury (AKI) (creatinine ≥90μmol/L; 1mg/dL)

 -  Liver involvement (elevated transaminases e.g. alanine transaminase (ALT) or aspartate
 aminotransferase (AST) >40IU/L) with or without right upper quadrant or epigastric
 abdominal pain

 -  Neurological complications e.g. eclampsia, altered mental status, blindness, stroke,
 clonus, severe headaches and persistent visual scotomata

 -  Haematological complications (thrombocytopenia - platelet count <150 000/μL,
 disseminated intravascular coagulation, haemolysis

 -  Uteroplacental dysfunction (fetal growth restriction, abnormal umbilical artery
 doppler wave form analysis, or stillbirth)

 Exclusion Criteria:

 -  Unable to tolerate taste of beetroot juice concentrate during taste test

 -  Multiple pregnancy

 -  History of acute or chronic liver conditions (aside from preeclampsia)

 -  Fetal aneuploidies or major fetal anomalies

 -  Unwillingness to comply with all study-related procedures e.g. Women who have used
 mouthwash or tongue scraping in last 7 days and are not able/unwilling unable to stop
 this for the duration of the study

 -  Women on treatment for gingivitis

 -  Women with persistent hyperemesis or ptyalism

 -  On Proton-pump-inhibitors/antacids other treatment for gastritis/peptic ulcer/gastric
 ulcers

 -  Those with long term antibiotic use e.g. prophylaxis of urinary tract infections
 (UTIs) or those who are likely to need repeated courses of antibiotics e.g. history of
 recurrent UTI

 -  Women with known allergy/intolerance to beetroot or lemon

 -  Type 1 and Type 2 diabetics

 -  Moderate iron deficiency anaemia with haemoglobin <100g/dL and/or ferritin <15μg/L

 -  Any blood disorder or significant illness that may affect platelet function and
 coagulation. However, patients taking low-dose aspirin (150mg) for preeclampsia
 prophylaxis who are at increased risk of developing preeclampsia will be included in
 the study.

 -  History of alcohol or recreational drug abuse use within the past 6 months

 -  Systemic autoimmune disease e.g. Rheumatoid Arthritis, antiphospholipid syndrome
 connective tissue disease e.g. Systemic Lupus Erythematous or other conditions known
 to be associated with chronic inflammation such as inflammatory bowel disease -
 Chron's disease/Ulcerative Colitis

 -  Women not intending to deliver at the recruiting site

 -  Participating in another intervention study that influences the outcomes of this study

 -  Those with serious mental illness or learning difficulties and unable to give written
 informed consent

 -  Those who are detained as a prisoner or detained in any secured unit, including those
 held under the Mental Health Act

 -  Those not fluent in local language, and absence of appropriate interpreter despite use
 of services such as Language Line