Last updated: October 29, 2020
Sponsor: King's College Hospital NHS Trust
Overall Status: Active - Recruiting
Phase
N/A
Condition
Williams Syndrome
High Blood Pressure (Hypertension - Pediatric)
Circulation Disorders
Treatment
N/AClinical Study ID
NCT04604535
263871
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Aged ≥18
- Able to give written informed consent
- Singleton pregnancies, between 24+0 to 36+6 weeks gestation with new onset gestationalhypertension (defined by ISSHP2018 as new onset BP >140/90 and no evidence ofproteinuria, 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 <20week's gestation) Or
- Singleton pregnancies, between 24+0 - 36+6 weeks gestation, with preeclampsia (definedby ISSHP2018 as Gestational hypertension accompanied by ≥ 1 of the following new onsetconditions 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 aspartateaminotransferase (AST) >40IU/L) with or without right upper quadrant or epigastricabdominal 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 arterydoppler wave form analysis, or stillbirth)
Exclusion
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 usedmouthwash or tongue scraping in last 7 days and are not able/unwilling unable to stopthis 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/gastriculcers
- 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 ofrecurrent 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 andcoagulation. However, patients taking low-dose aspirin (150mg) for preeclampsiaprophylaxis who are at increased risk of developing preeclampsia will be included inthe study.
- History of alcohol or recreational drug abuse use within the past 6 months
- Systemic autoimmune disease e.g. Rheumatoid Arthritis, antiphospholipid syndromeconnective tissue disease e.g. Systemic Lupus Erythematous or other conditions knownto 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 writteninformed consent
- Those who are detained as a prisoner or detained in any secured unit, including thoseheld under the Mental Health Act
- Those not fluent in local language, and absence of appropriate interpreter despite useof services such as Language Line
Study Design
Total Participants: 320
Study Start date:
October 22, 2020
Estimated Completion Date:
December 30, 2022
Study Description
Connect with a study center
King's College Hospital
London,
United KingdomActive - Recruiting

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