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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorSaint Thomas Hospital, Panama

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preeclampsia with severe features.

Gestational age 24 weeks - 41 weeks.

Disqualifiers

Chronic lung disease.

Known heart disease.

Diagnosis of lung edema at admission

Body mass index > 40

Trial design

Design model

Single group

Treatments tested in this trial

  • Lung ultrasound

    Diagnostic test

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

Treatment groups

202 Participants
are divided into 1 treatment group
Group A: Severe preeclampsiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Lung Ultrasound evaluation

Three or more B Lines in at least two lung zones using lung ultrasound

Time frame
One evaluation at admission, another one just before delivery and a final one 24 hours after delivery

Secondary outcomes

1

Dyspnea

Subjective sensation of difficulty breathing

Time frame
Report of the symptom by the patient from admission for up to three days
2

Tachypnea

Respiratory rate above 20 breaths/min

Time frame
Report of the symptom from admission for up to three days.
3

Oxygen saturation

Oxygen saturation measured by pulse oxymeter

Time frame
Report of the value measured by a pulse oxymeter from admission for up to three days

Other outcomes

Sponsors and contacts

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