Management of Postpartum Preeclampsia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the effect of a lower treatment threshold for antihypertensive medication and tighter blood pressure control, using remote blood pressure monitoring, on reducing Emergency Room visits for our postpartum patients with hypertensive disease.

Detailed Description
-----------------
The aim of this study is to assess the effect of lower treatment threshold for initiating antihypertensive medication and tighter blood pressure control, using remote blood pressure monitoring, on reducing Emergency Room visits for our postpartum patients with hypertensive disease. The investigators will study and compare two cohorts of patients. The first is a retrospective cohort, including patients delivered at Robert Wood Johnson University Hospital and Cooperman Barnabas Medical Center. The second is a prospective cohort that will enroll patients immediately postpartum who are eligible for our treatment protocol.

Official Title
-----------------
Management of Postpartum Preeclampsia

Conditions
-----------------
Postpartum Preeclampsia

Intervention / Treatment
-----------------
* Other: Tight postpartum blood pressure control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hypertension, gestational hypertension, or preeclampsia. Delivery of a neonate after 20 weeks during their current hospitalization Able to consent 18 years old or above English or Spanish speaking Planning to follow up with a physician associated with Robert Wood Johnson University Hospital or Cooperman Barnabas Medical Center Ability to follow directions Exclusion Criteria: Any medical condition that the providers feel is a contraindication to the MOPP algorithm. Planning to follow up with an outside institution. Unwillingness to take blood pressure at home.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: The investigators will study and compare two cohorts of patients. The first is a retrospective cohort, including patients delivered at Robert Wood Johnson University Hospital and Cooperman Barnabas Medical Center. The second is a prospective cohort that will enroll patients immediately postpartum who are eligible for our treatment protocol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective interventional arm<br>The prospective cohort will identify patients in the postpartum period of their delivery hospitalization who are at risk of readmission for hypertensive disorders in the initial six weeks postpartum. Those at risk include patients with diagnosed with chronic hypertension or PIH. Chronic hypertension is defined as either taking antihypertensive medications or a blood pressure of greater than or equal to 140/90 mm Hg prior to 20 weeks of gestation. Pregnancy induced hypertension includes gestational hypertension, preeclampsia without severe features, preeclampsia with severe features and Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP). The minimum requirement to be diagnosed with this spectrum of disorders is having two blood pressures of greater than or equal to 140/90 mm Hg during the antepartum, intrapartum or postpartum periods. | Other: Tight postpartum blood pressure control<br>* The standard of care for patients with pregnancy induced hypertension is to start antihypertensive therapy if blood pressures are consistently over 150/100 mm Hg. There is no established standard of care for titrating blood pressure medication in the postpartum period for those with chronic hypertension and the approach to these patients varies by institution. The intervention in this study will be to start antihypertensive medications at a lower blood pressure cutoff, which is commonly used in the non-pregnant patient population to more tightly control blood pressure. Remote patient monitoring may be considered standard of care. The blood pressure targets chosen for this study are considered to be standard of care for non-pregnant people.<br>|
| No Intervention: Retrospective observational arm<br>The retrospective cohort will include all patients diagnosed with chronic hypertension or pregnancy-induced hypertensive (PIH) disorders at Robert Wood Johnson University Hospital and Cooperman Barnabas Medical Center in the past two years, including those presenting to the Emergency Department or readmitted for hypertensive disorders, during the immediate six weeks postpartum. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum Emergency Department visits for hypertensive disorders | Any patient that returns to the Emergency Department for hypertensive disorders | Six weeks from date of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum readmissions for hypertensive disorders | Any patient that is readmitted to the hospital for hypertensive disorders. | 6 weeks form date of delivery | 
| Number of acute postpartum complications of preeclampsia | Postpartum complications include stroke, seizure, thrombocytopenia, elevated liver enzymes, liver rupture, kidney injury. | 6 weeks from date of delivery | 
| Lab abnormalities because of preeclampsia | Rate of lab abnormalities including acute kidney injury (creatinine >1.1 mg/dL), transaminitis (liver function tests > 2x upper limit of normal), or thrombocytopenia (platelet count < 100,000 uL) | 6 weeks from date of delivery | 
| Blood pressure at the postpartum visit | Measurement of blood pressure value at 6 week postpartum visit | 6 weeks from date of delivery | 
| Breastfeeding rates at 6 weeks postpartum | Rates of exclusive breastfeeding at 6 week postpartum visit. | 6 weeks from date of delivery | 
| Compliance with follow up at postpartum visits | If patient shows up to postpartum visit or not | 6 weeks from date of delivery | 
| Composite maternal cardiovascular and other morbidity | Death, any new heart failure, stroke or encephalopathy, myocardial ischemia or angina, pulmonary edema, ICU admission/ intubation, encephalopathy, or renal failure. | One year from delivery | 
| Short-term cardiovascular disease | The effect of aggressive postpartum preeclampsia on incidents of cardiovascular diseases, which include coronary heart disease (acute myocardial infarction, ischemic heart disease, hypertensive heart disease, and congestive heart failure), and stroke (ischemic and hemorrhagic strokes). | One year from delivery | 
| Socioeconomic factors | The impact of race/ethnicity and insurance status on primary and secondary outcomes. | One year from delivery |