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NCT Number: NCT07752056

Low-Sodium Diet for Postpartum Blood Pressure Control

The goal of this randomized controlled trial is to learn if a low-sodium diet improves postpartum blood pressure control in adults who were diagnosed with a late-onset hypertensive disorder of pregnancy.

The main questions it aims to answer are:

* Does a low-sodium diet lead to decreased mean arterial blood pressure (MAP) on postpartum day 7? * Does a low-sodium diet lead to a decreased MAP on postpartum day 3? * Does a low-sodium diet reduce 30-day hospital readmissions for hypertension-related indications?

Participants will be provided with meals for 7 days following their delivery. The experimental diet will contain less than 2000mg of sodium daily. The control diet will have variable sodium content with no restrictions. Participants will be asked to record the food they consume over the study week. They will also be provided with a blood pressure (BP) cuff and asked to record their BP at least once daily.

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Key information

Conditions

Hypertensive Disorder of Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Hypertension Hypertension, Pregnancy-Induced Immune System Diseases Immunoproliferative Disorders Infections Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Postpartum Pre-Eclampsia Pre-Eclampsia, Severe Pre-Eclampsia; Mild Pregnancy Complications Toxemia Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

This study is a prospective, single-center randomized controlled trial (RCT). Due to the nature of the intervention, providers and participants will not be blinded to the study group.

In this RCT, researchers will assess if sodium restriction (less than 2000 mg daily) in the postpartum setting leads to lower blood pressure (BP) in those diagnosed with a hypertensive disorder of pregnancy (HDP). Individuals diagnosed with HDP (gestational hypertension, pre-eclampsia, chronic hypertension with superimposed pre-eclampsia) after 34 weeks' gestation will be eligible for the study. Recruitment will occur in the hospital prior to their first food intake postpartum.

Following delivery, participants will be randomized 1:1 to either the experimental group (diet with < 2000 mg sodium daily) or the control group (diet with variable sodium content per preference). While in the hospital, the experimental group will receive a "low salt diet" and the control group will receive a "regular diet" provided by hospital dietary services. Following discharge, participants will be provided meals from Meals on Wheels according to their assigned study diet for a total of seven days following delivery. They will also be provided a log to record the food they eat each day. The daily sodium content will be calculated for each participant and averaged over the 7-day study period.

While in the hospital, participants will have their BP checked and recorded every 4 hours by nursing staff. At the time of discharge, participants will be provided with a BP cuff and instructions for how to measure their BP at home. They will be asked to check and record their BP at least once daily.

The primary outcome will be the difference in mean arterial pressure (MAP) between groups on postpartum day 7. The MAP will be calculated for each participant based on their recorded BP values on postpartum day 7. Secondary outcomes will be the difference in MAP on postpartum day 3 and the difference in 30-day hospital readmission rates for hypertension between groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults > 18 years of age
  • Singleton pregnancy
  • Diagnosis of HDP at or beyond 34 weeks' gestation (gestational hypertension, pre-eclampsia, pre-eclampsia with severe features, chronic hypertension with superimposed pre-eclampsia)
  • Agree to remote BP monitoring after hospital discharge
  • English or Spanish as primary language

Exclusion criteria

  • Multiple gestations
  • Pre-existing renal or cardiac disease, liver failure
  • Pre-existing condition in which salt restriction is not advised (SIADH, Addison's Disease, cystic fibrosis, chronic diarrhea, presence of ileostomy)
  • Dietary restrictions: vegetarian, gluten-free, lactose-free, Kosher, severe food allergies, among others

Treatment and study plan

Low sodium diet

Other

7-day provided diet with total daily sodium intake restricted to less than 2000mg

Primary outcomes

  1. Difference in Mean Arterial Blood Pressure (MAP) on Postpartum Day 7

    Time frame: 7 days following delivery

    Participants in both groups will check their blood pressure (BP) at least once daily with a provided cuff. On postpartum day 7, the average MAP for each participant will be calculated from all available BP values. The difference in MAP on postpartum day 7 between the experimental and control groups will serve as the primary outcome.

Secondary outcomes

  1. Difference in Mean Arterial Blood Pressure (MAP) on Postpartum Day 3

    Time frame: 3 days following delivery

    While in the hospital, participants will have their blood pressure (BP) checked regularly by nursing staff. Once discharged home, participants will check their blood pressure at least once daily with a provided cuff. On postpartum day 3, the average MAP for each participant will be calculated from all available BP values. The difference in MAP on postpartum day 3 between the experimental and control groups will serve as a secondary outcome.

  2. Difference in 30-Day Postpartum Readmission Rates for Hypertension

    Time frame: Within 30 days of delivery

    The incidence of hospital readmission for hypertension-related indications within 30 days of delivery will be tracked and compared between the experimental and control groups.

Other outcomes

  1. Magnesium Sulfate Started After Delivery

    Time frame: Within 30 days of delivery

    Researchers will record whether a participant received magnesium sulfate for eclampsia prophylaxis following delivery. The rate of receiving magnesium sulfate will be compared between the experimental and control groups.

  2. Antihypertensives Started After Delivery

    Time frame: Within 30 days of delivery

    Researchers will record whether antihypertensive medications were started after delivery in participants who were not previously taking antihypertensives. The rates of initiating antihypertensive medications will be compared between the experimental and control groups.

  3. Diuretics Started After Delivery

    Time frame: Within 30 days of delivery

    Researchers will record whether diuretic medications were started following delivery in participants who were not previously taking diuretics. The rates of initiating diuretics will be compared between experimental and control groups.

  4. Postpartum New Diagnosis of Severe Pre-Eclampsia

    Time frame: Within 30 days of delivery

    Researchers will record whether a participant was diagnosed with severe pre-eclampsia (or pre-eclampsia with severe features) following delivery, in those who did not previously meet these criteria. The rates of newly diagnosed severe pre-eclampsia in the postpartum setting will be compared between the experimental and control groups.

  5. Postpartum Severe Maternal Morbidity

    Time frame: Within 30 days of delivery

    Researchers will record whether a participant meets criteria for severe maternal morbidity in the postpartum setting, defined as: stroke, seizure/eclampsia, posterior reversible encephalopathy syndrome [PRES], pulmonary edema, cardiomyopathy, hemolysis elevated liver enzymes and low platelets [HELLP syndrome], delayed postpartum hemorrhage [blood loss > 1000cc more than 24 hours after delivery], venous thromboembolism, acute kidney injury, elevated transaminases). The rates of severe maternal morbidity will be compared between the experimental and control groups.

  6. Postpartum Maternal Intensive Care Unit (ICU) Transfer

    Time frame: Within 30 days of delivery

    Researchers will record whether a participant is admitted to the ICU for any indication in the postpartum setting. The rates of ICU admission will be compared between experimental and control groups.

  7. Highest Blood Pressure Recorded

    Time frame: Within 7 days of delivery

    The highest blood pressure (BP) value of each participant within the first week postpartum will be documented. The highest recorded BP will then be averaged among all participants in each respective group. The difference in mean highest BP will be compared between the experimental and control groups.

  8. Antihypertensive Dose Increase Following Discharge

    Time frame: Within 30 days of delivery

    Researchers will record whether participants who were discharged with a prescription for an antihypertensive medication required a dose increase following hospital discharge. The rates of requiring dose increase will be compared between the experimetnal and control groups.

  9. Additional Food Consumption

    Time frame: Within 30 days of delivery

    Participants will record the food they consume during the first week after delivery. Researchers will record whether any "outside food" (food not provided in the study meals) was consumed. The rates of consuming outside food will be compared between the experimental and control groups.

  10. Daily Sodium Intake

    Time frame: Within 7 days of delivery

    Participants will record all food and beverage items they consume during the week following delivery. Researchers will record the sodium content of each food item and sum it to a daily total. Following the seven-day dietary period, the average daily sodium intake will be calculated for each participant. Daily sodium intake will then be averaged for all participants in each respective study group. The average daily sodium intake will be compared between experimental and control groups.

  11. Emergency Room Visits for Hypertension

    Time frame: Within 30 days of delivery

    Researchers will record whether participants presented to the emergency room within 30 days of delivery for a hypertension-related etiology. The rates of emergency room visits will be compared between experimental and control groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathryn Anderson, MD

CONTACT

[email protected]

401-274-1122

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Collaborators

  • Meals on Wheels Rhode Island (MOWRI)

Registry information

Official study title

Low-Sodium Diet for Postpartum Blood Pressure Control in Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

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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