Status:
ENROLLING_BY_INVITATION
Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Lead Sponsor:
University of California, Irvine
Conditions:
Preeclampsia
Preeclampsia Postpartum
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 dy...
Detailed Description
Preeclampsia is a condition of the antenatal and postpartum periods, which manifests as new-onset hypertension and proteinuria. Globally, preeclampsia is estimated to affect up to 9% of all pregnancie...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT07167862
Start Date
November 1 2025
End Date
March 15 2027
Last Update
September 26 2025
Active Locations (1)
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1
University of California Irvine Medical Center
Orange, California, United States, 92868