Ultrasound and Furosemide for Preeclampsia

(PPPOCUS Trial)

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of California, Irvine

Must not be taking: Diuretics

Disqualifiers: Chronic hypertension, Renal dysfunction, Hypokalemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for new mothers with preeclampsia, a condition that causes high blood pressure after childbirth. Researchers will use a quick ultrasound scan to check for excess fluid in the body. If they find too much fluid, participants will receive a diuretic medicine called furosemide to help remove it. The goal is to speed up blood pressure recovery, reduce the need for medication, and decrease hospital readmissions. This trial seeks participants diagnosed with preeclampsia within 24 hours after giving birth. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently using diuretics for other conditions, you may not be eligible to participate.

What is the safety track record for furosemide and POCUS in treating postpartum preeclampsia?

Research has shown that furosemide, the treatment used in this study, is generally safe for individuals with preeclampsia, a pregnancy condition causing high blood pressure and other issues. Studies have found that furosemide can help lower blood pressure in women after childbirth. Compared to a placebo, women taking furosemide were 60% less likely to experience high blood pressure seven days postpartum.

Regarding safety, furosemide is usually well-tolerated. Some studies have reported side effects such as low potassium levels, increased thirst, headaches, and muscle cramps, though these are uncommon. The FDA has already approved furosemide for other uses, indicating its well-established safety profile. Overall, furosemide is considered safe for most individuals, and any side effects are typically manageable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using ultrasound-guided furosemide for preeclampsia because it offers a personalized and potentially more effective approach to managing this condition. Unlike standard treatments, which often focus on controlling blood pressure with medications like labetalol or methyldopa, this method uses point-of-care ultrasound (POCUS) to tailor diuretic therapy based on specific hemodynamic criteria. By targeting excess fluid accumulation more precisely with either intravenous or oral furosemide, the treatment aims to reduce complications and improve recovery after delivery. This innovative approach could lead to faster and more targeted relief for patients suffering from preeclampsia.

What evidence suggests that this trial's treatments could be effective for preeclampsia?

Research has shown that furosemide, a medication that helps the body eliminate excess fluid, can control blood pressure in women with preeclampsia after childbirth. In this trial, participants will be divided into cohorts to receive either intravenous or oral furosemide. Studies have found that both injected and pill forms of furosemide significantly improve blood pressure control in these women. A short course of furosemide after giving birth effectively lowers blood pressure, often leading to quicker recovery. Specifically, taking furosemide as a pill has been noted to reduce the systolic blood pressure within the first few days after childbirth. These findings suggest that furosemide is a promising option for managing high blood pressure in women with preeclampsia after delivery. ^{1 3 6 7 8}

Who Is on the Research Team?

Ashten B Waks, MD, MSPH

Principal Investigator

University of California, Irvine

Are You a Good Fit for This Trial?

This trial is for postpartum patients with preeclampsia, a condition causing high blood pressure and potential organ issues after pregnancy. Participants should have persistent high blood pressure at hospital discharge and may require ongoing medication.

Inclusion Criteria

I am 18 years old or older.

Historical cohort (group 1): Gestational age greater than or equal to 20 weeks' gestation at delivery

Historical cohort (group 1): Delivery at the study institution within the 18-month period prior to implementation of the study's POCUS intervention

Exclusion Criteria

Prospective cohorts (groups 2 and 3): Known hypersensitivity to furosemide or sulfa drugs; selected because this would preclude exposure to the study medication of interest

I am currently taking diuretics for a condition like heart failure.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo POCUS assessment and receive diuretic therapy if criteria are met

5 days

Daily visits for POCUS assessment and treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Weekly follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Furosemide

Trial Overview The study tests if using the Butterfly iQ3 ultrasound to detect excess fluid in the lungs can guide better treatment with furosemide (a diuretic) to improve recovery from preeclampsia, reduce need for long-term medication, and prevent readmissions.

How Is the Trial Designed?

Group I: Cohort 2: POCUS-guided subjects receiving intravenous furosemide Experimental Treatment 2 Interventions

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.

Group II: Cohort 1: POCUS-guided subjects receiving oral furosemide Experimental Treatment 2 Interventions

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.

Group III: Cohort 3: Historical matched controls Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37214156/

Furosemide for postpartum blood pressure control in ... The aim of our study is to evaluate the effectiveness of furosemide in postpartum patients with pre-eclampsia and chronic hypertension with superimposed pre- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933325000151

Postpartum furosemide for accelerating recovery in ... This clinical trial evaluated the effectiveness of furosemide (40 mg/day) in controlling blood pressure in women with severe preeclampsia and ...

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.16133

Furosemide for Accelerated Recovery of Blood Pressure ... A short course of postpartum furosemide significantly improved blood pressure control in women with hypertensive disorders of pregnancy, mostly among women ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04615624

Furosemide vs. Placebo for Severe Antepartum Hypertension Previous studies have demonstrated the safety and efficacy of furosemide to treat preeclampsia in the antepartum and postpartum period as well as its utility ...

5. ajogmfm.org ajogmfm.org/article/S2589-9333(25)00015-1/abstract

Postpartum furosemide for accelerating recovery in ... This study aimed to evaluate the effectiveness of furosemide compared with a placebo for blood pressure control in the postpartum period in women with severe ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8099047/

a randomized controlled trial (FoR BP trial) Primary outcomes​​ There was a 60% reduction in the risk of persistent hypertension at 7-days postpartum in women randomized to furosemide versus placebo (6% vs. ...

7. ahajournals.org ahajournals.org/doi/pdf/10.1161/HYPERTENSIONAHA.120.16133

Hypertension - CLINICAL TRIAL Other outcomes assessed were adverse effects associated with furosemide (hypokalemia, polydipsia, headaches, mental confusion, muscle aches, tetany, muscle ...

8. ajog.org ajog.org/article/S0002-9378(24)00522-2/fulltext

Lasix for the prevention of de novo postpartum hypertension Although the impact of furosemide remains inconclusive, the treatment exhibited good tolerance in terms of maternal, neonatal, and breastfeeding outcomes.