Low-Sodium Diet for Postpartum Blood Pressure Control
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen and Infants Hospital of Rhode Island
About this 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:
* 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Low Sodium Diet
Other intervention7-day provided diet with total daily sodium intake restricted to less than 2000mg
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Low-Sodium DietExperimental treatment 1 intervention
Group B: Regular DietNo intervention 0 interventions
Trial outcomes
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.
Time frame
7 days following deliverySecondary outcomes
1
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 delivery2
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 deliveryOther outcomes
1
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 delivery2
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 delivery3
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 delivery4
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 deliveryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Women and Infants Hospital of Rhode Island
Lead sponsor
Meals on Wheels Rhode Island (MOWRI)
Collaborator
Source ClinicalTrials.gov
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