Using inorganic nitrate to treat high blood pressure in pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of inorganic nitrate supplementation on pregnant women diagnosed with chronic hypertension. Eligible participants will be randomly assigned to receive either a capsule containing inorganic nitrate or a placebo starting from the 16th week of their pregnancy. The study aims to assess the impact of this supplementation on blood pressure and uterine artery health, which are crucial for both maternal and fetal well-being. Participants will continue their standard medications for preeclampsia prophylaxis throughout the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
  Ribeirão Preto, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Ricardo C Cavalli, Dr — Medical School of Ribeirao Preto, USP
• Study coordinator: Ricardo C Cavalli, Dr
• Email: rcavalli@fmrp.usp.br
• Phone: +55166021000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Telehealth and remote blood pressure management for pregnant women with chronic high blood pressure

  This study tests whether alternating telehealth visits with home blood pressure monitoring and health coaching helps pregnant women (18–45) with chronic high blood pressure compared with standard in-person care.

  Recruiting Wake Forest University Health Sciences · Winston-Salem, North Carolina · NCT07356518

• Improving postpartum-to-primary care transitions for people with chronic conditions

  This study tests whether embedding default PCP appointments, tailored reminder messages, and care recommendations into routine inpatient postpartum care helps people with chronic conditions connect with primary care after delivery.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT06557005

• Measuring Blood Pressure in Pregnant Women Using Different Cuffs

  This study is testing if a special forearm cuff gives more accurate blood pressure readings for pregnant women compared to a regular upper arm cuff, especially for those who are very overweight.

  Recruiting Northwestern University · Chicago, Illinois · NCT06466161

• Using low-dose aspirin after preeclampsia to improve recovery

  This study is testing if taking low-dose aspirin for six months after having preeclampsia can help new moms recover better by improving their blood pressure and blood vessel function.

  Recruiting Phase 4 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT06281665

• Understanding cardiovascular risks in young adults born to hypertensive pregnancies

  This study is looking at the heart health of young adults in their 20s and 30s who were born to mothers with high blood pressure during pregnancy to see if it affects their risk of heart problems later on.

  Recruiting University of Oxford · Oxford, Oxfordshire · NCT05683093

• A large cohort study on prenatal and early life factors affecting children's health in China

  This study looks at how things like pregnancy and early feeding habits affect the health and growth of children in China.

  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT03217656

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.