The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy

This is an interventional treatment trial for Hypertension in Pregnancy Read More

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