Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT07167862
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Preeclampsia
  • Preeclampsia Postpartum
  • Preeclampsia Severe or Mild

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Butterfly iQ3 ultrasound system for determination of postpartum volume status — DIAGNOSTIC_TEST
    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.
  • Oral furosemide — DRUG
    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.
  • Intravenous furosemide — DRUG
    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 second cohort of 48 patients will be treated with a single dose of intravenous furosemide 40mg and oral potassium chloride 40mEq on postpartum day 1.

Study Details

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.

Key Dates

Start date
Jun 15, 2026
Status verified
Jan 2026
Primary completion
Jun 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: POCUS-guided subjects receiving oral furosemide
    A prospective cohort of patients diagnosed with preeclampsia who will be enrolled and undergo POCUS within 24 hours of delivery. Those meeting pre-specified hemodynamic criteria (\> 3 B-lines, maximum IVC diameter \> 2 cm, and/or IVC collapsibility index \< 15%) will receive a 5-day course of oral furosemide 20mg and oral potassium chloride 40mEq daily.
  • Experimental: Cohort 2: POCUS-guided subjects receiving intravenous furosemide
    A prospective cohort of patients diagnosed with preeclampsia who will be enrolled and undergo POCUS within 24 hours of delivery. Those meeting pre-specified hemodynamic criteria (\> 3 B-lines, maximum IVC diameter \> 2 cm, and/or IVC collapsibility index \< 15%) will receive a single dose of intravenous furosemide 40mg and oral potassium chloride 40mEq.
  • Active Comparator: Cohort 3: Historical matched controls
    A retrospective cohort comprised of patients who delivered before implementation of POCUS-guided postpartum management of preeclampsia (1/1/2024 - 6/1/2025). These patients will be selected from the electronic medical record and matched to enrolled patients for variables such as age, body mass index, gestational age at delivery, severity of preeclampsia, and mode of delivery.

Primary Outcome Measure

Proportion of subjects with persistent hypertension at time of postpartum hospital discharge [ Time Frame: From study enrollment through completion of study participation, an average of 7 days or less ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Irvine Medical CenterOrangeCalifornia92868-

Find similar trials in Orange, CA

By research site
University of California Irvine Medical Center· Orange, CA

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