The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy (NCT04604535) | Clinical Trial Compass
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The BEET-BP Trial - Investigating the Effect of Dietary Nitrates on Hypertension in Pregnancy
United Kingdom320 participantsStarted 2020-10-22
Plain-language summary
This is a randomised placebo controlled trial investigating the effects of dietary nitrate supplementation on hypertension in pregnancy
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Gestational age of delivery secondary to preeclampsia