MOPP: Management of Postpartum Preeclampsia

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05775744

Collaborator

(none)

409

Enrollment

Locations

Arms

27.6

Anticipated Duration (Months)

204.5

Patients Per Site

7.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Preeclampsia	Other: Tight postpartum blood pressure control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

409 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

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.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)

Primary Purpose:

Treatment

Official Title:

Management of Postpartum Preeclampsia

Anticipated Study Start Date :

Mar 13, 2023

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cooperman Barnabas Medical Center	Livingston	New Jersey	United States	07039
2	Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Deepika Sagaram, MD, Assistant Clinical Professor, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT05775744

Other Study ID Numbers:

Pro2022001222

First Posted:

Mar 20, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pre-Eclampsia

Study Results

No Results Posted as of Mar 20, 2023