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NCT07167862

PHASE4

Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound

Sponsor: University of California, Irvine

View on ClinicalTrials.gov

Summary

This study explores a novel approach to improving care for postpartum patients with preeclampsia, a pregnancy-related condition characterized by high blood pressure, protein in the urine, and organ dysfunction. Preeclampsia affects up to 9% of pregnancies and can progress to include complications of seizures, stroke, and even death. Over 60% of patients with preeclampsia continue to experience high blood pressure at the time of discharge from their delivery hospitalization, and many of these patients require blood pressure medications for up to 6 months postpartum. Even with blood pressure medications, many of these patients are readmitted to the hospital within six weeks of delivery. In this study, the investigators will utilize point-of-care ultrasound (POCUS), a quick and non-invasive, bedside imaging strategy, to look for signs of excess fluid accumulating in the lungs and venous system of postpartum patients with preeclampsia. Because excess fluid has the potential to worsen blood pressure, subjects with evidence of this on POCUS would be treated with a diuretic medication called furosemide (either orally or intravenously) within 24 hours of delivery. The investigators' main goal is to determine whether using POCUS can help physicians make better treatment decisions and improve short-term outcomes for postpartum patients with preeclampsia. The investigators' aim to achieve faster recovery of blood pressure, reduce the need for blood pressure medication at hospital discharge, and lower the rates of hospital readmission for those with preeclampsia. This study could significantly enhance the overall care and health of postpartum patients.

Official title: Optimizing Preeclampsia Postpartum With Point-of-Care Ultrasound: A Pilot Prospective Cohort Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-06-15

Completion Date

2028-06-15

Last Updated

2026-01-23

Healthy Volunteers

Conditions

Preeclampsia Preeclampsia Postpartum Preeclampsia Severe or Mild

Interventions

DIAGNOSTIC_TEST

Butterfly iQ3 ultrasound system for determination of postpartum volume status

A trained study staff member will perform point-of-care ultrasound (POCUS) of the lungs and the inferior vena cava (IVC). All POCUS assessments will be performed using either the curvilinear or phased array settings on a portable Butterfly iQ3 ultrasound system. Images obtained via the Butterfly iQ3 ultrasound system will be labeled according to the subject's unique identification number and transmitted directly to a digital study archive. The lead investigator or physician of record will review all captured ultrasound images to ensure that an appropriate therapy is selected moving forward. Any subject who is confirmed to have 3 or more B-lines, a maximum IVC diameter above 2.0cm, or an IVC collapsibility index less than 15% on POCUS will become a candidate for diuretic therapy, which will be ordered by the patient's primary inpatient provider.

DRUG

Oral furosemide

Any subject who is confirmed to have 3 or more B-lines, a maximum IVC diameter above 2.0cm, or an IVC collapsibility index less than 15% on POCUS will become a candidate for diuretic therapy, which will be ordered by the patient's primary inpatient provider. The first cohort of 48 patients will be treated with oral furosemide 20mg daily and oral potassium chloride 40mEq daily for a total of 5-days. As patients delivered vaginally are typically discharged 2-3 days after birth and delivered via cesarean are typically discharged 4-5 days after birth, patients who have not yet completed the medication course by the time of planned discharge will be prescribed the remainder of their medications before departing the hospital.

DRUG

Intravenous furosemide

Inclusion Criteria: Historical cohort (group 1): * Age greater than or equal to 18 years at the time of delivery * Diagnosis of preeclampsia (without severe features, with severe features, HELLP syndrome, eclampsia) during pregnancy * Gestational age greater than or equal to 20 weeks' gestation at delivery * Delivery at the study institution within the 18-month period prior to implementation of the study's POCUS intervention * Available and complete postpartum clinical data on: Daily blood pressure, diuretic or antihypertensive use, length of postpartum hospital stay, readmission within 30 days of primary hospitalization Prospective cohorts (groups 2 and 3): * Age greater than or equal to 18 years at the time of enrollment * Diagnosis of preeclampsia (without severe features, with severe features, HELLP syndrome, eclampsia) made up until 24 hours postpartum Postpartum and within 24 hours of delivery Exclusion Criteria: Historical cohort (group 1): * Delivery at an outside facility or incomplete postpartum records available for analysis * Pre-existing diagnosis of chronic hypertension; selected to mirror prospective cohort exclusion criteria (see below). * Documentation of chronic kidney disease (CKD stage 3 or higher); selected because diuresis is more likely to be avoided in this patient population even in the presence of physical exam findings suggesting volume overload. * Documentation of postpartum complications unrelated to preeclampsia that may significantly alter hemodynamics (e.g., sepsis, postpartum hemorrhage); selected because diuresis is more likely to be avoided in this patient population even in the presence of physical exam findings suggesting volume overload. Prospective cohorts (groups 2 and 3): * Pre-existing diagnosis of chronic hypertension; selected because previous studies on furosemide use in patients with postpartum preeclampsia have found a significant reduction in hypertension among patients with newly diagnosed hypertensive disorders of pregnancy, but not among those with pre-gestational hypertension, meaning that inclusion of this population might reduce the magnitude of study effects. * Baseline renal dysfunction with serum creatinine \> 1.1 mg/dL; selected as this laboratory finding has been pre-selected as a safety outcome. * Baseline hypokalemia with serum potassium \< 3.5 mEq/L despite previous repletion with intravenous or oral potassium chloride; selected as this laboratory finding has been pre-selected as a safety outcome. * Known hypersensitivity to furosemide or sulfa drugs; selected because this would preclude exposure to the study medication of interest. * Current use of diuretics for other indications (e.g. heart failure); selected because this may require a furosemide or other diuretic regimen different from that planned for the study intervention.

Locations (1)

University of California Irvine Medical Center

Orange, California, United States