Recruiting

Phase 4

POCUS with FurosemideOptimizing Preeclampsia Postpartum With Point-of-care Ultrasound

Sponsor:

UCLA

Code:

NCT07167862

Conditions

Preeclampsia

Preeclampsia Postpartum

Preeclampsia Severe or Mild

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Butterfly iQ3 ultrasound system for determination of postpartum volume status

Oral furosemide

Intravenous furosemide

Study Details

Brief 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.

Conditions

Preeclampsia

Preeclampsia Postpartum

Preeclampsia Severe or Mild

Study ID

NCT07167862

Start date

Oct 26, 2026

Status verified date

Jan, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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.

Intravenous furosemide

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 ]
Average days to resolution of hypertension [ Time Frame: From study enrollment through completion of study participation, an average of 7 days or less ]

Central Contacts and Locations

Central contacts

Ashten B Waks, MD, MSPH

714-456-2911 awaks@hs.uci.edu

Locations

University of California Irvine Medical Center

Recruiting

Orange, California, United States, 92868

Contacts

Ashten B Waks, MD, MSPH

(714) 456-7890 awaks@hs.uci.edu

Principal Investigator:

Afshan B Hameed, MD, MBA

More Information

Sponsor

University of California, Irvine

Last update posted

Nov 2, 2026

Last verified

Jan, 2026

Keywords

Preeclampsia
Postpartum
Point of care ultrasound
Diuretics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.