Hypertensive Disorder of PregnancyNCT07752056
Low-Sodium Diet for Postpartum Blood Pressure Control
A study testing Low Sodium Diet in people with Hypertensive Disorder of Pregnancy and Pre-Eclampsia, Severe, run by Women and Infants Hospital of Rhode Island.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Severe, Pre-Eclampsia; Mild
- What is being tested?
- Low Sodium Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Low-Sodium Diet for Postpartum Blood Pressure Control in Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Severe, Pre-Eclampsia; Mild, Postpartum
- Being tested
- Low Sodium Diet
- Keywords
- sodium, hypertensive disorder of pregnancy, postpartum, pre-eclampsia, diet, salt, high blood pressure
- Medical subject headings
- Toxemia, Pre-Eclampsia, Lymphoma, Follicular, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Sodium DietOther
7-day provided diet with total daily sodium intake restricted to less than 2000mg
| Study group | Role | What they receive |
|---|---|---|
| Low-Sodium Diet | Experimental | 7-day provided diet with total daily sodium intake restricted to less than 2000mg Receives: Other: Low Sodium Diet |
| Regular Diet | No intervention | 7-day provided diet with variable sodium content in meals. Sodium intake per participant preference, no restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Mean Arterial Blood Pressure (MAP) on Postpartum Day 7
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.
Measured: 7 days following delivery
Secondary outcomes (2)
Difference in Mean Arterial Blood Pressure (MAP) on Postpartum Day 3
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.
Measured: 3 days following delivery
Difference in 30-Day Postpartum Readmission Rates for Hypertension
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.
Measured: Within 30 days of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Meals on Wheels Rhode Island (MOWRI)
- Responsible party
- Sponsor
- Investigators
- Adam Lewkowitz, MD, Principal investigator, Care New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752056
- Sponsor's protocol ID
- 2401212
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication of the primary manuscript, blinded data, the study protocol, the statistical analysis plan, the informed consent form, and the clinical study report will be available upon request to the study team.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Sodium Diet for Postpartum Blood Pressure Control in Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07752056
- Acronym / sponsor ID
- 2401212
- Conditions
- Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Severe, Pre-Eclampsia; Mild, Postpartum
- Keywords
- sodium, hypertensive disorder of pregnancy, postpartum, pre-eclampsia, diet, salt, high blood pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Collaborators
- Meals on Wheels Rhode Island (MOWRI)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Sodium Diet | Experimental | Other: Low Sodium Diet7-day provided diet with total daily sodium intake restricted to less than 2000mg |
| Regular Diet | No intervention | –7-day provided diet with variable sodium content in meals. Sodium intake per participant preference, no restriction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Sodium Diet7-day provided diet with total daily sodium intake restricted to less than 2000mg | Other | Low-Sodium Diet |
Primary outcome
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.
2 secondary outcomes
Difference in Mean Arterial Blood Pressure (MAP) on Postpartum Day 3
Time frame: 3 days following delivery
Difference in 30-Day Postpartum Readmission Rates for Hypertension
Time frame: Within 30 days of delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. Following publication of the primary manuscript, blinded data, the study protocol, the statistical analysis plan, the informed consent form, and the clinical study report will be available upon request to the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Lewkowitz, MD principal investigator
Care New England
Questions about this trial
What is this clinical trial studying?
A study testing Low Sodium Diet in people with Hypertensive Disorder of Pregnancy and Pre-Eclampsia, Severe, run by Women and Infants Hospital of Rhode Island.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Anderson, MD (401-274-1122, kathryn.anderson24@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Mean Arterial Blood Pressure (MAP) on Postpartum Day 7 (time frame: 7 days following delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.