Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound

NCT07167862 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 7178
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

Preeclampsia; Postpartum; Point of care ultrasound; Diuretics

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with persistent hypertension at time of postpartum hospital discharge

  Persistent hypertension at time of postpartum hospital discharge, defined both as blood pressure \> 140/90 mm Hg according to American College of OB/GYN (ACOG) guidelines and 130/80 mm Hg according to Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-9) guidelines

  From study enrollment through completion of study participation, an average of 7 days or less

• Average days to resolution of hypertension

  Days to resolution of hypertension, defined both as blood pressure \< 140/90 mm Hg according to ACOG guidelines and 130/80 mm Hg according to JNC-9 guidelines

  From study enrollment through completion of study participation, an average of 7 days or less

Secondary Outcomes (7)

• Proportion of subjects requiring antihypertensive medications at hospital discharge

  From study enrollment through completion of study participation, an average of 7 days or less

• Proportion of subjects requiring a secondary antihypertensive therapy at hospital discharge

  From study enrollment through completion of study participation, an average of 7 days or less

• Average length of hospital stay

  From birth through completion of study participation, an average of 7 days or less

• Proportion of patients with a change in POCUS results over time

  From study enrollment through completion of study participation, an average of 7 days or less

• Mean change in BNP levels over time

  From study enrollment through completion of study participation, an average of 7 days or less

Other Outcomes (4)

• Proportion of patients with hypotension

  From study enrollment through completion of study participation, an average of 7 days or less

• Proportion of patients with tachycardia

  From study enrollment through completion of study participation, an average of 7 days or less

• Proportion of patients with moderate or severe hypokalemia

  From study enrollment through completion of study participation, an average of 7 days or less

Study Arms (3)

Cohort 1: POCUS-guided subjects receiving oral furosemide

EXPERIMENTAL

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.

Diagnostic Test: Butterfly iQ3 ultrasound system for determination of postpartum volume status; Drug: Oral furosemide

Cohort 2: POCUS-guided subjects receiving intravenous furosemide

EXPERIMENTAL

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.

Diagnostic Test: Butterfly iQ3 ultrasound system for determination of postpartum volume status; Drug: Intravenous furosemide

Cohort 3: Historical matched controls

ACTIVE COMPARATOR

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.

Drug: Oral furosemide; Drug: Intravenous furosemide

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.

Cohort 1: POCUS-guided subjects receiving oral furosemide; Cohort 2: POCUS-guided subjects receiving intravenous furosemide

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.

Also known as: Oral Lasix

Cohort 1: POCUS-guided subjects receiving oral furosemide; Cohort 3: Historical matched controls

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.

Also known as: Intravenous Lasix

Cohort 2: POCUS-guided subjects receiving intravenous furosemide; Cohort 3: Historical matched controls

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Historical cohort (group 1):
• Delivery at an outside facility or incomplete postpartum records available for analysis
• 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):
• 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.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California Irvine Medical Center

Orange, California, 92868, United States

Location

Related Publications (10)

• Ambrozic J, Brzan Simenc G, Prokselj K, Tul N, Cvijic M, Lucovnik M. Lung and cardiac ultrasound for hemodynamic monitoring of patients with severe pre-eclampsia. Ultrasound Obstet Gynecol. 2017 Jan;49(1):104-109. doi: 10.1002/uog.17331. Epub 2016 Dec 1.

  PMID: 27736042 BACKGROUND

• Parra E, Brackney K, Piersall L, et al. (2025, January 26 - February 1). (1024) Comparing inferior vena cava collapsibility in postpartum patients with and without severe preeclampsia. Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting, Denver, CO, United States.

  BACKGROUND

• Gevaerd Martins J, Saad A, Saade G, Pacheco LD. The role of point-of-care ultrasound to monitor response of fluid replacement therapy in pregnancy. Am J Obstet Gynecol. 2024 Dec;231(6):563-573. doi: 10.1016/j.ajog.2024.06.039. Epub 2024 Jul 3.

  PMID: 38969197 BACKGROUND

• Chong Y, Yu Y, Zhao Y, Zhang Y. Value of inferior vena cava diameter and inferior vena cava collapse index in the evaluation of peripartum volume: A prospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2023 Jun;285:69-73. doi: 10.1016/j.ejogrb.2023.03.045. Epub 2023 Apr 11.

  PMID: 37062116 BACKGROUND

• Lopes Perdigao J, Lewey J, Hirshberg A, Koelper N, Srinivas SK, Elovitz MA, Levine LD. Furosemide for Accelerated Recovery of Blood Pressure Postpartum in women with a hypertensive disorder of pregnancy: A Randomized Controlled Trial. Hypertension. 2021 May 5;77(5):1517-1524. doi: 10.1161/HYPERTENSIONAHA.120.16133. Epub 2021 Feb 8.

  PMID: 33550824 BACKGROUND

• Ascarelli MH, Johnson V, McCreary H, Cushman J, May WL, Martin JN Jr. Postpartum preeclampsia management with furosemide: a randomized clinical trial. Obstet Gynecol. 2005 Jan;105(1):29-33. doi: 10.1097/01.AOG.0000148270.53433.66.

  PMID: 15625138 BACKGROUND

• Balhotra K, Roach C, Al-Kouatly HB, Minkoff H, McLaren RA Jr. Association of antihypertensive medication at discharge with readmission for postpartum preeclampsia. Am J Obstet Gynecol. 2023 Jun;228(6):747-748.e1. doi: 10.1016/j.ajog.2023.01.020. Epub 2023 Jan 27. No abstract available.

  PMID: 36716985 BACKGROUND

• Stevens W, Shih T, Incerti D, Ton TGN, Lee HC, Peneva D, Macones GA, Sibai BM, Jena AB. Short-term costs of preeclampsia to the United States health care system. Am J Obstet Gynecol. 2017 Sep;217(3):237-248.e16. doi: 10.1016/j.ajog.2017.04.032. Epub 2017 Jul 11.

  PMID: 28708975 BACKGROUND

• Ditisheim A, Wuerzner G, Ponte B, Vial Y, Irion O, Burnier M, Boulvain M, Pechere-Bertschi A. Prevalence of Hypertensive Phenotypes After Preeclampsia: A Prospective Cohort Study. Hypertension. 2018 Jan;71(1):103-109. doi: 10.1161/HYPERTENSIONAHA.117.09799. Epub 2017 Nov 13.

  PMID: 29133363 BACKGROUND

• Gestational Hypertension and Preeclampsia: ACOG Practice Bulletin, Number 222. Obstet Gynecol. 2020 Jun;135(6):e237-e260. doi: 10.1097/AOG.0000000000003891.

  PMID: 32443079 BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia; Lymphoma, Follicular

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Ashten B Waks, MD, MSPH

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashten B Waks, MD, MSPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 11, 2025
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)