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Recruiting NCT07261956

Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia

No phase Interventional Pulmonary Edema - Acute Preeclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lung ultrasound.
Who it may be relevant to
Registry conditions: Pulmonary Edema - Acute, Preeclampsia. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Panama
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Usefulness of Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia

Overview

This research aims to evaluate the usefulness of lung ultrasound (LUS) for detecting and monitoring fluid overload in patients with severe preeclampsia. Severe preeclampsia is a leading cause of maternal death and illness worldwide, often causing fluid buildup that can lead to a serious complication called pulmonary edema, especially after delivery. The study will be a prospective, longitudinal observational study with a diagnostic validation component. It will involve patients with a diagnosis of severe preeclampsia who meet specific inclusion criteria. Each participant will undergo a clinical exam and a lung ultrasound, which will assess eight zones of the lungs. The total number of B-lines-a sign of interstitial edema-will be documented. Data will be collected at three key times: upon admission, in the immediate postpartum period (within 24 hours of delivery), and 7-10 days postpartum. The results from the LUS will be compared to clinical signs like shortness of breath, rapid breathing, crackling sounds in the lungs, and oxygen saturation levels. The expected impact of this research is to provide evidence that LUS is a valuable, non-invasive, and accessible tool for the early detection of pulmonary congestion in patients with severe preeclampsia. This could lead to improved clinical decision-making and a reduction in maternal respiratory complications.

Interventions

  • Diagnostic test Lung ultrasound
    Lung ultrasounf at three moments (at admission, before delivery and immediate post partum) to determine B Lines

Primary outcome measures

  • Lung Ultrasound evaluation [Time frame: One evaluation at admission, another one just before delivery and a final one 24 hours after delivery]
Secondary outcome measures (3)
  • Dyspnea [Time frame: Report of the symptom by the patient from admission for up to three days]
  • Tachypnea [Time frame: Report of the symptom from admission for up to three days.]
  • Oxygen saturation [Time frame: Report of the value measured by a pulse oxymeter from admission for up to three days]

Eligibility criteria

Inclusion criteria

  • Preeclampsia with severe features.
  • Gestational age 24 weeks - 41 weeks.

Exclusion criteria

  • Chronic lung disease.
  • Known heart disease.
  • Diagnosis of lung edema at admission
  • Body mass index > 40
  • Need for immediate delivery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Panama · 1 center
  • Saint Thomas Hospital — Panama City

Identifiers

NCT: NCT07261956 · 4377

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗