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Completed

NCT Number: NCT05775744

Management of Postpartum Preeclampsia

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.

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Key information

Conditions

Postpartum Preeclampsia

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cooperman Barnabas Medical Center, Livingston, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tight postpartum blood pressure control

Other

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 outcomes

  1. 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

Secondary outcomes

  1. Postpartum readmissions for hypertensive disorders

    Time frame: 6 weeks form date of delivery

    Any patient that is readmitted to the hospital for hypertensive disorders.

  2. 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.

  3. 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)

  4. Blood pressure at the postpartum visit

    Time frame: 6 weeks from date of delivery

    Measurement of blood pressure value at 6 week postpartum visit

  5. Breastfeeding rates at 6 weeks postpartum

    Time frame: 6 weeks from date of delivery

    Rates of exclusive breastfeeding at 6 week postpartum visit.

  6. Compliance with follow up at postpartum visits

    Time frame: 6 weeks from date of delivery

    If patient shows up to postpartum visit or not

  7. 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.

  8. 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).

  9. Socioeconomic factors

    Time frame: One year from delivery

    The impact of race/ethnicity and insurance status on primary and secondary outcomes.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Acronym: MOPP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2023
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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