Actively Recruiting
Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies
Led by University of Sao Paulo · Updated on 2026-04-20
144
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo
Lead Sponsor
H
Hospital das Clínicas de Ribeirão Preto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 investigate the effects of inorganic nitrate supplementation on pregnant women from the start of their pregnancy and continuing it throughout their term. If our findings are positive, it could revolutionize how we approach blood pressure management during pregnancy, paving the way for healthier futures for both mothers and babies.
CONDITIONS
Official Title
Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and FEBRASGO Protocols.
- 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.
You will not qualify if you...
- 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 160x110 mmHg.
- 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 (plasma creatinine clearance less than 30 ml/min/1.73 m6), pre-existing type 1 or type 2 diabetes.
- Pregnant women who frequently used non-steroidal anti-inflammatory drugs, nasal decongestants, anorectics before pregnancy; users of proton pump inhibitors, H2 receptor antagonists or any medication interfering with stomach pH, starting 2 weeks before the study and continuing throughout.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, Brazil
Actively Recruiting
Research Team
R
Ricardo C Cavalli, Dr
CONTACT
P
Priscila O Barbosa, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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