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
Qualifiers
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
Treatments tested in this trial
- Low Sodium Diet
Treatment groups
110 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Women and Infants Hospital of Rhode Island
Lead sponsor
Meals on Wheels Rhode Island (MOWRI)
Collaborator
Source ClinicalTrials.gov