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OpenTrials
Completed

NCT Number: NCT02520687

Effects of Dietary Nitrate in Hypertensive Pregnant Women

High blood pressure in pregnancy affects around 10% of pregnancies, and is associated with serious adverse outcomes for both mother and baby. Treatment options for the management of high blood pressure in pregnancy are currently limited. Studies in non-pregnant individuals have shown that supplementation with dietary nitrate, using beetroot juice, can significantly lower blood pressure and improve blood flow. This study aims to investigate whether supplementation with dietary nitrate (via beetroot juice) can improve blood pressure regulation in pregnant women with chronic high blood pressure, and will also determine whether this can improve blood flow across the placenta.

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Key information

Conditions

Hypertension Cardiovascular Diseases Pregnancy Vascular Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maternal and Fetal Health Research Centre

Manchester, M13 9WL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with chronic hypertension (systolic blood pressure of 130-144 mmHg and/or diastolic blood pressure of 80-94 mmHg).
  • Between 22 - 35+6 weeks gestation

Exclusion criteria

  • Multi-fetal pregnancy
  • Currently taking anti-hypertensive medication
  • Pre-existing diabetes (Type 1 or Type 2)
  • Lacking ability to consent

Treatment and study plan

Beetroot juice

Dietary Supplement

70mls daily for seven days

Nitrate-depleted beetroot juice

Dietary Supplement

70mls daily for seven days

Primary outcomes

  1. Change in clinic blood pressure (compared to baseline) between treatment and placebo groups

    Time frame: The outcome will be determined after 7 days treatment (compared to baseline)

Secondary outcomes

  1. Recruitment rates

    Time frame: Across study (18 months)

  2. Uterine artery blood flow (compared to baseline)

    Time frame: The outcome will be determined after 7 days treatment (compared to baseline)

  3. Umbilical artery blood flow (compared to baseline)

    Time frame: The outcome will be determined after 7 days treatment (compared to baseline)

  4. Changes in plasma and salivary nitrate concentrations

    Time frame: The outcome will be determined after 7 days treatment (compared to baseline)

  5. Changes in plasma and salivary nitrite concentrations

    Time frame: The outcome will be determined after 7 days treatment (compared to baseline)

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Registry information

Official study title

Feasibility Study on the Effects of Dietary Nitrate on Cardiovascular Function in Hypertensive Pregnant Women

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 13, 2015
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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