Status:
RECRUITING
Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Hospital das Clínicas de Ribeirão Preto
Conditions:
Hypertension in Pregnancy
Hypertension
Eligibility:
FEMALE
16+ years
Phase:
NA
Brief Summary
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,...
Detailed Description
Eligible pregnant women with chronic hypertension will be identified and invited to participate through posters displayed in the municipality's health units, as well as by medical professionals within...
Eligibility Criteria
Inclusion
- 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
- Multiple pregnancies, age below 16 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.
Key Trial Info
Start Date :
March 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06105775
Start Date
March 6 2025
End Date
December 1 2026
Last Update
March 26 2025
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, São Paulo, Brazil