Low-Sodium Diet for Postpartum Blood Pressure Control in Hypertensive Disorders of Pregnancy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Difference in Mean Arterial Blood Pressure (MAP) on Postpartum Day 7
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Low-Sodium Diet
7-day provided diet with total daily sodium intake restricted to less than 2000mg
干预措施: Low Sodium Diet (Other)
Regular Diet
7-day provided diet with variable sodium content in meals. Sodium intake per participant preference, no restriction
结局指标
主要结局
Difference in Mean Arterial Blood Pressure (MAP) on Postpartum Day 7
时间窗: 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.
次要结局
- 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)