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

NCT07261956 | Recruiting

• 1 other identifier: 4377
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Edema - Acute; Preeclampsia

Keywords

Pulmonary edema; Severe preeclampsia; B lines; Lung ultrasound

Outcome Measures

Primary Outcomes (1)

• Lung Ultrasound evaluation

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

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

Secondary Outcomes (3)

• Dyspnea

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

• Tachypnea

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

• Oxygen saturation

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

Study Arms (1)

Severe preeclampsia

EXPERIMENTAL

Pregnant subjects (24 weeks - 41 weeks) with severe preeclampsia

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasound DIAGNOSTIC_TEST

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

Severe preeclampsia

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Pulmonary Edema

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Osvaldo Reyes, MD

  Saint Thomas Hospital, Panama

  STUDY DIRECTOR

Central Study Contacts

Anna C Figueroa, MD

CONTACT

+507 69494250; annacfigue@gmail.com

Adriana Martinz, MD

CONTACT

amartinzmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Department

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: December 3, 2025
• Study Start: August 25, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)