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

NCT ID: NCT07261956

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-25

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Edema - Acute Preeclampsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Severe preeclampsia

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

Group Type EXPERIMENTAL

Lung ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Lung ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Saint Thomas Hospital, Panama

OTHER

Sponsor Role lead

Responsible Party

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Osvaldo A. Reyes T.

Head of Research Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osvaldo Reyes, MD

Role: STUDY_DIRECTOR

Saint Thomas Hospital, Panama

Locations

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Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

Site Status RECRUITING

Countries

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Panama

Central Contacts

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Anna C Figueroa, MD

Role: CONTACT

+507 69494250

Adriana Martinz, MD

Role: CONTACT

Facility Contacts

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Osvaldo A Reyes, MD

Role: primary

o11(507)65655041

Other Identifiers

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4377

Identifier Type: -

Identifier Source: org_study_id

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