Tests nitrate capsules for blood pressure in chronic hypertensive pregnancies
Tests inorganic nitrate capsules against placebo in pregnant women with chronic high blood pressure.
Plain-language title generated from the registry record
Registry title: Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies
Key facts
- Where
- Ribeirão Preto, BrazilSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant women with long-term high blood pressure who take methyldopa alone. It tests a daily nitrate capsule against a placebo capsule.
- Age
- 18 years or older
- Sex
- Women only
- Disease stage
- Chronic high blood pressure (above 140 mmHg systolic and/or above 90 mmHg diastolic) before pregnancy or before 20 weeks of pregnancy. Less than 16 weeks of pregnancy, confirmed by a first-trimester ultrasound.
- Earlier treatment
- Must be treated with methyldopa alone at the time of joining. Must not have regularly used non-steroidal anti-inflammatory drugs, nasal decongestants or anorectics before pregnancy.
Main reasons for not taking part
- Twin or other multiple pregnancy
- Blood pressure above 160x110mmHg that is not controlled
- Food allergies, especially to beetroot
- Illicit drug use, smoking or alcohol abuse
- Heart disease, moderate to severe liver failure, kidney failure or diabetes
This trial only enrols pregnant participants. The registry sentence this rests on: 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.
Read by machine on 12 November 2026.
Where in Brazil
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto - USPRibeirão Preto, BrazilContact: PRISCILA O BARBOSA, DrTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Sao Paulo
- Trial code
- NCT06105775
- Record updated
- 20 April 2026
- Original description
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.Read full original descriptionShow less
Inorganic Nitrate Supplementation for Blood Pressure Control in Chronic Hypertensive Pregnancies From the 2nd Trimester (NIT_CH): a Triple-Blind Randomized Placebo-Controlled Trial
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.
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: Users of illicit drugs, smokers, or alcohol abusers; 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; Patients with uncontrolled chronic hypertension, with blood pressure values above 160x110mmHg; History of food allergies, especially hypersensitivity to beetroot; 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; Multiple pregnancies, age below 18 years old, inability to provide informed consent, or history of low adherence to medication therapy.