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Management of Postpartum Preeclampsia (MOPP)

Primary Purpose

Postpartum Preeclampsia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tight postpartum blood pressure control
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Preeclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cooperman Barnabas Medical Center
  • Robert Wood Johnson Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prospective interventional arm

Retrospective observational arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postpartum Emergency Department visits for hypertensive disorders
Any patient that returns to the Emergency Department for hypertensive disorders

Secondary Outcome Measures

Postpartum readmissions for hypertensive disorders
Any patient that is readmitted to the hospital for hypertensive disorders.
Number of acute postpartum complications of preeclampsia
Postpartum complications include stroke, seizure, thrombocytopenia, elevated liver enzymes, liver rupture, kidney injury.
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)
Blood pressure at the postpartum visit
Measurement of blood pressure value at 6 week postpartum visit
Breastfeeding rates at 6 weeks postpartum
Rates of exclusive breastfeeding at 6 week postpartum visit.
Compliance with follow up at postpartum visits
If patient shows up to postpartum visit or not
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.
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).
Socioeconomic factors
The impact of race/ethnicity and insurance status on primary and secondary outcomes.

Full Information

First Posted
February 17, 2023
Last Updated
March 28, 2023
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT05775744
Brief Title
Management of Postpartum Preeclampsia
Acronym
MOPP
Official Title
Management of Postpartum Preeclampsia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Preeclampsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
409 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prospective interventional arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Retrospective observational arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tight postpartum blood pressure control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postpartum Emergency Department visits for hypertensive disorders
Description
Any patient that returns to the Emergency Department for hypertensive disorders
Time Frame
Six weeks from date of delivery
Secondary Outcome Measure Information:
Title
Postpartum readmissions for hypertensive disorders
Description
Any patient that is readmitted to the hospital for hypertensive disorders.
Time Frame
6 weeks form date of delivery
Title
Number of acute postpartum complications of preeclampsia
Description
Postpartum complications include stroke, seizure, thrombocytopenia, elevated liver enzymes, liver rupture, kidney injury.
Time Frame
6 weeks from date of delivery
Title
Lab abnormalities because of preeclampsia
Description
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)
Time Frame
6 weeks from date of delivery
Title
Blood pressure at the postpartum visit
Description
Measurement of blood pressure value at 6 week postpartum visit
Time Frame
6 weeks from date of delivery
Title
Breastfeeding rates at 6 weeks postpartum
Description
Rates of exclusive breastfeeding at 6 week postpartum visit.
Time Frame
6 weeks from date of delivery
Title
Compliance with follow up at postpartum visits
Description
If patient shows up to postpartum visit or not
Time Frame
6 weeks from date of delivery
Title
Composite maternal cardiovascular and other morbidity
Description
Death, any new heart failure, stroke or encephalopathy, myocardial ischemia or angina, pulmonary edema, ICU admission/ intubation, encephalopathy, or renal failure.
Time Frame
One year from delivery
Title
Short-term cardiovascular disease
Description
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).
Time Frame
One year from delivery
Title
Socioeconomic factors
Description
The impact of race/ethnicity and insurance status on primary and secondary outcomes.
Time Frame
One year from delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Rosenfeld, DO
Phone
732-253-6632
Email
er720@rwjms.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Shama Khan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepika Sagaram, MD
Organizational Affiliation
Rutgers, Robert Wood Johnson
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cooperman Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernani Sadural
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily B Rosenfeld, DO
First Name & Middle Initial & Last Name & Degree
Deepika Sagaram, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data will be provided to those inquiries to the corresponding author of the manuscript if published. If no manuscript is published, inquiries can be directed to the principal investigator.
IPD Sharing Time Frame
Data will be available on publication and will remain available for two years.
IPD Sharing Access Criteria
The principal investigator will individually assess all requests for data.
Citations:
PubMed Identifier
32473598
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Management of Postpartum Preeclampsia

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