An interventional study of Low Sodium Diet in Hypertensive Disorder of Pregnancy, Pre-Eclampsia, Severe and Pre-Eclampsia; Mild, sponsored by Women and Infants Hospital of Rhode Island. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Treatment
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:
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.
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.
Exclusion Criteria:
7-day provided diet with total daily sodium intake restricted to less than 2000mg
Other: Low Sodium Diet
7-day provided diet with variable sodium content in meals. Sodium intake per participant preference, no restriction
7-day provided diet with total daily sodium intake restricted to less than 2000mg
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.
Time frame: 7 days following delivery
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.
Time frame: 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.
Time frame: Within 30 days of delivery
Magnesium Sulfate Started After 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.
Time frame: Within 30 days of delivery
Antihypertensives Started After 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.
Time frame: Within 30 days of delivery
Diuretics Started After 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.
Time frame: Within 30 days of delivery
Postpartum New Diagnosis of Severe Pre-Eclampsia
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.
Time frame: Within 30 days of delivery
Postpartum Severe Maternal Morbidity
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.
Time frame: Within 30 days of delivery
Postpartum Maternal Intensive Care Unit (ICU) Transfer
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.
Time frame: Within 30 days of delivery
Highest Blood Pressure Recorded
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.
Time frame: Within 7 days of delivery
Antihypertensive Dose Increase Following Discharge
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 experimental and control groups.
Time frame: Within 30 days of delivery
Additional Food Consumption
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.
Time frame: Within 30 days of delivery
Daily Sodium Intake
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.
Time frame: Within 7 days of delivery
Emergency Room Visits for Hypertension
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.
Time frame: Within 30 days of delivery
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Women and Infants Hospital of Rhode Island