Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies

Launched by UNIVERSITY OF SAO PAULO · Oct 23, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of beetroot extract on pregnant women who have high blood pressure, a condition known as chronic hypertension. High blood pressure during pregnancy can pose risks to both mothers and babies, and while there are traditional medications available, their safety is often a concern. Beetroot has shown promise in early studies for helping to lower blood pressure and improve blood flow to the baby by relaxing the blood vessels. The researchers hope that using beetroot supplements throughout pregnancy could be a safer and effective way to manage high blood pressure, ultimately leading to healthier outcomes for mothers and their babies.

To participate in this trial, women must be pregnant and diagnosed with chronic hypertension, meaning their blood pressure was high before pregnancy or early in their pregnancy. They should also be less than 16 weeks pregnant and currently taking a specific medication called methyldopa. However, this trial excludes women with certain health conditions, those who are very overweight, or anyone who has had issues sticking to medication in the past. If eligible, participants can expect to take beetroot supplements and will be monitored throughout their pregnancy to see how well it helps manage their blood pressure. This research could change how we treat high blood pressure during pregnancy, making it safer for both mothers and their babies.

Gender

FEMALE

Eligibility criteria

• 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 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.