Optimizing Preeclampsia Postpartum With Point-of-care Ultrasound
Optimizing Preeclampsia Postpartum With Point-of-Care Ultrasound: A Pilot Prospective Cohort Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 months
- Procedures mentioned: Ultrasound, Physical exams
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- "With regards to evaluating postpartum volume status and how it might relate to diuretic response, most obstetric practitioners currently rely on findings from physical examination (e.g. jugular venous distension, rales on lung exam, peripheral edema) that are known to have limited sensitivity."
- "This review suggested that the presence of three or more B-lines per screen on lung ultrasound is indicative of pulmonary edema during pregnancy and the postpartum period, as B-lines develop when air content in the lungs is replaced by transudate or exudate in the interstitium."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a quick bedside ultrasound can guide care after birth for people with preeclampsia, a pregnancy-related condition that causes high blood pressure and can harm organs. Patients with extra fluid seen on the scan will get furosemide, a medicine that helps the body remove extra fluid, within 24 hours after birth. The goal is to improve blood pressure, reduce the need for blood pressure medicine, and prevent return hospital stays.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- New study groups: Be age 18 or older when joining.
- New study groups: Have preeclampsia diagnosed during pregnancy or within 24 hours after birth, including severe forms.
- New study groups: Join after giving birth and within 24 hours of delivery.
- Past-records group: Have been age 18 or older at delivery.
- Past-records group: Have had preeclampsia during pregnancy, including severe forms.
- Past-records group: Have given birth at 20 weeks of pregnancy or later.
- Past-records group: Have delivered at the study hospital in the 18 months before the ultrasound study began.
- Past-records group: Have complete records after birth showing daily blood pressure, medicines used, hospital stay length, and any return hospital stays within 30 days.
Who can't join
- All groups: Have long-term high blood pressure that started before pregnancy.
- Past-records group: Delivered at another hospital or have incomplete records after birth.
- Past-records group: Have long-term kidney disease at stage 3 or higher.
- Past-records group: Have other problems after birth that greatly affect blood flow or pressure, such as a severe infection or heavy bleeding.
- New study groups: Have reduced kidney function, shown by a blood creatinine level above 1.1 mg/dL.
- New study groups: Have low blood potassium, below 3.5 mEq/L, even after receiving potassium treatment.
- New study groups: Have a known allergy to furosemide or sulfa drugs.
- New study groups: Already take medicine to remove extra fluid for another condition, such as heart failure.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 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 Criteria: 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.
Study sites (1)
CA
- University of California Irvine Medical Center · Orange, CA 92868More trials in Orange