Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound

ConditionsPreeclampsia Preeclampsia Postpartum Preeclampsia Severe or Mild

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18+

SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.

Treatment groups

96 Participants

are divided into 3 treatment groups

Group A: Cohort 1: POCUS-guided subjects receiving oral furosemideExperimental treatment 2 interventions

Group B: Cohort 2: POCUS-guided subjects receiving intravenous furosemideExperimental treatment 2 interventions

Group C: Cohort 3: Historical matched controlsActive comparator 2 interventions

Trial outcomes

Primary outcomes

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

Time frame

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

Time frame

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

Secondary outcomes

Proportion of subjects requiring antihypertensive medications at hospital discharge

Need for antihypertensive medication at postpartum hospital discharge

Time frame

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

Addition of second antihypertensive agent during postpartum hospitalization

Time frame

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

Average length of hospital stay

Length of postpartum hospitalization

Time frame

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

Change in POCUS results from positive to negative for evidence of volume overload from the time of study enrollment through hospital discharge

Time frame

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

Other outcomes

Proportion of patients with hypotension

Hypotension, defined as blood pressure \< 90 mm Hg systolic and/or \< 60 mm Hg diastolic

Time frame

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

Proportion of patients with tachycardia

Tachycardia, defined as heart rate \> 100 beats per minute

Time frame

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

Proportion of patients with moderate or severe hypokalemia

Moderate or severe hypokalemia, defined as potassium \< 3.0 mEq/L

Time frame

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

Proportion of patients with acute kidney injury

Acute kidney injury, defined as creatinine \> 1.1 mg/dL

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Source ClinicalTrials.gov

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