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NCT Number: NCT07261956

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas Hospital

Panama City, Provincia de Panamá, Panama

Location status: Recruiting

Location contact

Osvaldo A Reyes, MD

CONTACT

[email protected]

o11(507)65655041

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung Ultrasound

Diagnostic Test

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

Primary outcomes

  1. Lung Ultrasound evaluation

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

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

Secondary outcomes

  1. Dyspnea

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

    Subjective sensation of difficulty breathing

  2. Tachypnea

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

    Respiratory rate above 20 breaths/min

  3. Oxygen saturation

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

    Oxygen saturation measured by pulse oxymeter

Study contacts

Contact information is provided by the study sponsor or research team.

Adriana Martinz, MD

CONTACT

[email protected]

Anna C Figueroa, MD

CONTACT

[email protected]

+507 69494250

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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