Management of Postpartum Preeclampsia
- Conditions
- Postpartum Preeclampsia
- Interventions
- Other: Tight postpartum blood pressure control
- Registration Number
- NCT05775744
- Lead Sponsor
- Rutgers, The State University of New Jersey
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 392
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prospective interventional arm Tight postpartum blood pressure control 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.
- Primary Outcome Measures
Name Time Method Postpartum Emergency Department visits for hypertensive disorders Six weeks from date of delivery Any patient that returns to the Emergency Department for hypertensive disorders
- Secondary Outcome Measures
Name Time Method Postpartum readmissions for hypertensive disorders 6 weeks form date of delivery Any patient that is readmitted to the hospital for hypertensive disorders.
Number of acute postpartum complications of preeclampsia 6 weeks from date of delivery Postpartum complications include stroke, seizure, thrombocytopenia, elevated liver enzymes, liver rupture, kidney injury.
Lab abnormalities because of preeclampsia 6 weeks from date of delivery 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)
Blood pressure at the postpartum visit 6 weeks from date of delivery Measurement of blood pressure value at 6 week postpartum visit
Breastfeeding rates at 6 weeks postpartum 6 weeks from date of delivery Rates of exclusive breastfeeding at 6 week postpartum visit.
Compliance with follow up at postpartum visits 6 weeks from date of delivery If patient shows up to postpartum visit or not
Short-term cardiovascular disease One year from delivery 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).
Socioeconomic factors One year from delivery The impact of race/ethnicity and insurance status on primary and secondary outcomes.
Composite maternal cardiovascular and other morbidity One year from delivery Death, any new heart failure, stroke or encephalopathy, myocardial ischemia or angina, pulmonary edema, ICU admission/ intubation, encephalopathy, or renal failure.
Trial Locations
- Locations (2)
Cooperman Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States