Clinical trial NCT05775744: Management of Postpartum Preeclampsia
Official title: Management of Postpartum Preeclampsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Preeclampsia
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 392
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postpartum Emergency Department visits for hypertensive disorders
timeFrame: Six weeks from date of delivery
Secondary outcomes:
measure: Postpartum readmissions for hypertensive disorders
timeFrame: 6 weeks form date of delivery
measure: Number of acute postpartum complications of preeclampsia
timeFrame: 6 weeks from date of delivery
measure: Lab abnormalities because of preeclampsia
timeFrame: 6 weeks from date of delivery
measure: Blood pressure at the postpartum visit
timeFrame: 6 weeks from date of delivery
measure: Breastfeeding rates at 6 weeks postpartum
timeFrame: 6 weeks from date of delivery
measure: Compliance with follow up at postpartum visits
timeFrame: 6 weeks from date of delivery
measure: Composite maternal cardiovascular and other morbidity
timeFrame: One year from delivery
measure: Short-term cardiovascular disease
timeFrame: One year from delivery
measure: Socioeconomic factors
timeFrame: One year from delivery
Other outcomes:
Locations:
city: Livingston
country: United States
facility: Cooperman Barnabas Medical Center
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers, Robert Wood Johnson
name: Deepika Sagaram, MD
role: PRINCIPAL_INVESTIGATOR
References:
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