Management of Postpartum Preeclampsia (MOPP)

April 1, 2024 updated by: Deepika Sagaram, MD, Rutgers, The State University of New Jersey
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Shama Khan

Study Locations

  • United States
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Cooperman Barnabas Medical Center
        • Contact:
          • Ernani Sadural
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
        • Contact:
          • Emily B Rosenfeld, DO
        • Principal Investigator:
          • Deepika Sagaram, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prospective interventional arm
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
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.
No Intervention: Retrospective observational arm
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
Time Frame: Six weeks from date of delivery
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
Time Frame: 6 weeks form date of delivery
Any patient that is readmitted to the hospital for hypertensive disorders.
6 weeks form date of delivery
Number of acute postpartum complications of preeclampsia
Time Frame: 6 weeks from date of delivery
Postpartum complications include stroke, seizure, thrombocytopenia, elevated liver enzymes, liver rupture, kidney injury.
6 weeks from date of delivery
Lab abnormalities because of preeclampsia
Time Frame: 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)
6 weeks from date of delivery
Blood pressure at the postpartum visit
Time Frame: 6 weeks from date of delivery
Measurement of blood pressure value at 6 week postpartum visit
6 weeks from date of delivery
Breastfeeding rates at 6 weeks postpartum
Time Frame: 6 weeks from date of delivery
Rates of exclusive breastfeeding at 6 week postpartum visit.
6 weeks from date of delivery
Compliance with follow up at postpartum visits
Time Frame: 6 weeks from date of delivery
If patient shows up to postpartum visit or not
6 weeks from date of delivery
Composite maternal cardiovascular and other morbidity
Time Frame: 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.
One year from delivery
Short-term cardiovascular disease
Time Frame: 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).
One year from delivery
Socioeconomic factors
Time Frame: One year from delivery
The impact of race/ethnicity and insurance status on primary and secondary outcomes.
One year from delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Deepika Sagaram, MD, Rutgers, Robert Wood Johnson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2023

Primary Completion (Actual)

March 26, 2024

Study Completion (Actual)

March 26, 2024

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria

March 7, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2022001222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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