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Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies

RecruitingNAAges 18 Years - anyFemaleUniversity of Sao Paulo
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In plain words

What the trial is, and whether it could suit you

High blood pressure during pregnancy poses significant risks to both the mother and baby. A combination of factors, including advancing maternal age, rising obesity rates, and metabolic health issues, have amplified the prevalence of this condition. While conventional medicines are available, safety during pregnancy remains a concern. Recent studies suggest that inorganic nitrate might be a safer alternative. The power of nitrate lies in its ability to stimulate the body's production of a compound that aids in dilating and relaxing blood vessels. Preliminary studies conducted on mice and a select group of pregnant women have yielded encouraging results. Early tests indicated that after consuming inorganic nitrate, there was a reduction in blood pressure and an improvement in the health of the mother's uterine artery-a vital vessel responsible for nourishing the fetus. Our study aims to i

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pregnant women diagnosed with chronic hypertension (systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg before pregnancy or before 20 weeks of gestation) as defined by the Brazilian Network for Studies on Hypertension in Pregnancy (RBEHG, Brazilian acronym) Protocol and Chronic Hypertension/Preeclampsia by the Brazilian Federation of Gynecology and Obstetrics Associations (FEBRASGO, Brazilian acronym) Protocol. * Patients on monotherapy with methyldopa as treatment at the time of inclusion. * Women with less than 16 weeks of gestation confirmed by first-trimester ultrasonography confirming gestational age. Exclusion Criteria: * Multiple pregnancies, age below 18 years old, inability to provide informed consent, or history of low adherence to medication therapy. * Patients with uncontrolled chronic hypertension, with blood pressure values above 160x110mmHg. * History of food allergies, especially hypersensitivity to beetroot. * Users of illicit drugs, smokers, or alcohol abusers. * Diagnosis of coronary artery disease, congestive heart failure (moderate to severe), moderate to severe liver failure, chronic renal insufficiency (with plasma creatinine clearance less than 30 ml/min/1.73 m² of body surface), pre-existing type 1 diabetes, and type 2 diabetes. * Pregnant women who frequently used non-steroidal anti-inflammatory drugs, nasal decongestants, and anorectics before getting pregnant; users of proton pump inhibitors and H2 receptor antagonists or any other medication that interferes with stomach pH, starting 2 weeks before the beginning and continuing throughout the remainder of the study.
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What it tests

  • Inorganic Nitrate Capsule
  • Placebo Capsule
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Where

1 site
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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