Inorganic Nitrate Supplementation in Chronic Hypertensive Pregnancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Sao Paulo
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Inorganic Nitrate Capsule
Dietary supplementStarting from the 16th week of gestation and continuing for 22 weeks (154 days) or until delivery, whichever comes first, participants will consume a daily capsule containing 400 mg of inorganic nitrate. Participants will maintain standard preeclampsia prophylaxis (acetylsalicylic acid 100mg nightly until 36 weeks of gestation and calcium carbonate 1000mg daily until delivery) and regular antihypertensive treatment.
Placebo Capsule
Dietary supplementFrom the 16th week of gestation and lasting 22 weeks (154 days) or until delivery, participants will consume a daily capsule containing sodium chloride with the nitrate replaced by plant-based flour, design to mimic the appearance of the active capsule. Participants will maintain standard preeclampsia prophylaxis (acetylsalicylic acid 100mg nightly until 36 weeks of gestation and calcium carbonate 1000mg daily until delivery) and regular antihypertensive treatment.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Inorganic Nitrate CapsuleExperimental treatment 1 intervention
Group B: Placebo Capsule.Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Blood Pressure Control in Chronic Hypertensive Pregnant Women with Inorganic Nitrate Supplementation Compared to Placebo.
Blood pressure will be assessed using semiautomatic equipment, measuring systolic and diastolic pressures in millimeters of mercury (mmHg). Ambulatory Blood Pressure Monitoring (ABMP) will be employed at the beginning of the clinical trial. Lower readings indicate better blood pressure control, while higher readings suggest poorer control.
Time frame
From baseline (16th week) up to delivery2
Increased Antihypertensive Medication Requirements in Patient Groups
The investigators will monitor both the inorganic nitrate group and the placebo group for any need to increase the dosage of antihypertensive medications, frequency or introduce a new agent.
Time frame
From baseline (16th week) up to deliverySecondary outcomes
1
Doppler Analysis of Maternal and Fetal Vessel Behavior Across Pregnancy in Both Groups
Using Doppler velocimetry, the investigators will evaluate fetal vessels, focusing on the middle cerebral artery and umbilical artery. These tests will be conducted with mothers resting in left lateral decubitus during fetal rest periods, excluding respiratory movements. Key parameters, including the systole/diastole (A/B) ratios, resistance index, and pulsatility index, will be captured. Concurrently, maternal Doppler velocimetry of the uterine artery and pulse wave velocity will be measured to assess arterial stiffness.
Time frame
From baseline (16th week) up to delivery2
Fetal Growth Assessment and Incidence of Fetal Growth Restriction in Both Groups
Fetal growth will be assessed using biometric measurements and evaluations like the fetal biophysical profile, placental maturity grade, and amniotic fluid evaluations. Key biometric parameters include biparietal diameter, cranial circumference, abdominal circumference, femur length, and estimated fetal weight (EFW). The "Hadlock" formula will help determine EFW, classifying the fetus as small for gestational age, average or large for gestational age. The biophysical profile will give insights into fetal movements and conditions over a 30-minute period. Placental maturity and amniotic fluid status will further provide context to the overall fetal health and growth.
Time frame
From baseline (16th week) up to delivery3
Incidence of Preeclampsia Overlap and Adverse Maternal Outcomes in Each Group
Clinical data will be collected to evaluate the presence of preeclampsia overlap and any associated adverse maternal outcomes. The collected data will include the gestational age at the time of delivery (in weeks + days), type of delivery (vaginal or cesarean), and specific clinical outcomes related to the mother's health
Time frame
At the time of delivery4
Incidence of Perinatal Outcomes
Post childbirth, perinatal outcomes will be assessed by recording essential metrics of the newborn. The collected data will include the newborn's gender, weight (measured in grams), length (measured in cm), and the Apgar scores documented at both the first- and fifth minutes post-birth.
Time frame
Immediately after delivery.Sponsors and contacts
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University of Sao Paulo
Lead sponsor
Hospital das Clínicas de Ribeirão Preto
Collaborator
Source ClinicalTrials.gov