Low-Sodium Diet for Postpartum Blood Pressure Control

NCT07752056 | Not Yet Recruiting

• 1 other identifier: 2401212
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pre-Eclampsia, Severe; Pre-Eclampsia; Mild; Postpartum; Hypertensive Disorder of Pregnancy

Keywords

sodium; hypertensive disorder of pregnancy; postpartum; pre-eclampsia; diet; salt; high blood pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  7 days following delivery

Secondary Outcomes (2)

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

  3 days following delivery

• Difference in 30-Day Postpartum Readmission Rates for Hypertension

  Within 30 days of delivery

Other Outcomes (11)

• Magnesium Sulfate Started After Delivery

  Within 30 days of delivery

• Antihypertensives Started After Delivery

  Within 30 days of delivery

• Diuretics Started After Delivery

  Within 30 days of delivery

Study Arms (2)

Low-Sodium Diet

EXPERIMENTAL

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

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

Interventions

Low Sodium Diet OTHER

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

Low-Sodium Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• Meals on Wheels Rhode Island (MOWRI): collaborator

MeSH Terms

Conditions

Toxemia; Pre-Eclampsia; Lymphoma, Follicular; Hypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Infections; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Adam Lewkowitz, MD

  Care New England

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Anderson, MD

CONTACT

401-274-1122; kathryn.anderson24@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: For up to five years following publication of the primary manuscript.
• Access Criteria: Individuals seeking study data will contact the study team directly, who will coordinate the transmission of the requested documents.