Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
NCT07167862 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2026-01-23
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
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
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.
Sponsors & Collaborators
-
University of California, Irvine
lead OTHER
Principal Investigators
-
Ashten B Waks, MD, MSPH · University of California, Irvine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-15
- Primary Completion
- 2028-06-15
- Completion
- 2028-06-15
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Preeclampsia Educational Program Study (PrEPS)
NCT06373367 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Fetal Adrenal Gland Volume Estimation in Prediction of Preterm Birth
NCT02339623 ·Status: UNKNOWN
-
Innovation in Postpartum Care for Women With Hypertensive Disorders of Pregnancy
NCT03613714 ·Status: COMPLETED ·Phase: NA
-
Optic Nerve Sheath Measurement and Angiogenic Factors in Patients With Pre-eclampsia.
NCT06122220 ·Status: RECRUITING ·Phase: NA
-
Furosemide for Accelerated Recovery of Blood Pressure Postpartum
NCT03556761 ·Status: COMPLETED ·Phase: PHASE2
-
Postpartum Preeclampsia Early Detection and Treatment: Nepal Pilot Study
NCT07185204 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Study to Determine if Serum BNP Levels Are Elevated in Pregnant Women With Pre-Eclampsia
NCT00533871 ·Status: COMPLETED
-
Thoracic Ultrasonography for Pulmonary Edema in Patients With Pre-Eclampsia
NCT02357264 ·Status: COMPLETED
-
At High-risk for Pre-eclampsia After Assisted Reproductive Technology
NCT05746793 ·Status: RECRUITING
-
Assessment of Optic Nerve Sheath Diameter in Preeclamptic Pregnant Women Using Ultrasonography and Anesthetic Management
NCT06522295 ·Status: NOT_YET_RECRUITING
-
Progesterone in Expectantly Managed Early-onset Preeclampsia
NCT04077853 ·Status: COMPLETED ·Phase: PHASE4
-
Physician Optimised Post-partum Hypertension Treatment Trial
NCT04273854 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Cardiovascular Protection After Preeclampsia With Enalapril
NCT07222852 ·Status: NOT_YET_RECRUITING ·Phase: PHASE3
-
Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor
NCT03251794 ·Status: COMPLETED
-
Kidney Injury Biomarkers in Preeclampsia
NCT03217916 ·Status: UNKNOWN
-
Preeclampsia and Fetal Heart Malformations: Looking to Maternal Heart
NCT07092644 ·Status: RECRUITING ·Phase: NA
-
Placental Protein 13 Serum Endoglin and Uterine Doppler Indeces as Predictors of Pre-eclampsia
NCT02350036 ·Status: COMPLETED
-
Use of Cheetah® Cardiac Monitoring System to Guide Discontinuation of Magnesium Sulfate in Women With Severe Preeclampsia
NCT04474704 ·Status: COMPLETED ·Phase: NA
-
Postpartum Readmission
NCT03026686 ·Status: TERMINATED
-
Study of the Physiology of Pre-eclampsia and Vascular IUGR With Constitution of a Biological Collection
NCT03626233 ·Status: UNKNOWN
-
Management of Postpartum Preeclampsia
NCT05775744 ·Status: COMPLETED ·Phase: NA
-
Hypertension Explored in Long-term Postpartum Follow-up in Later Life
NCT06187012 ·Status: RECRUITING
-
Goal-Directed Therapy in Pregnant Women at High Risk of Developing Preeclampsia
NCT01351428 ·Status: COMPLETED ·Phase: NA
-
Remote Postpartum Blood Pressure Monitoring and Cardiovascular Education
NCT06920563 ·Status: RECRUITING ·Phase: NA
-
Consequences of Antiangiogenic Factors Involved in Preeclampsia on Intra-uterine Growth Restricted Preterm Newborn
NCT01648855 ·Status: COMPLETED