Pulmonary Edema - AcuteNCT07261956
Lung Ultrasound for the Detection of Volume Overload in Patients With Severe Preeclampsia
A study testing Lung ultrasound in people with Pulmonary Edema - Acute and Preeclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pulmonary Edema - Acute, Preeclampsia
- What is being tested?
- Lung ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 sitePanama
- Study dates
- 25 Aug 2025to 31 Jan 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preeclampsia with severe features.
- Gestational age 24 weeks - 41 weeks.
Who cannot join
- Chronic lung disease.
- Known heart disease.
- Diagnosis of lung edema at admission
- Body mass index > 40
- Need for immediate delivery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Adriana Martinz, MD contact
Panama1 site, 1 recruiting
- Recruiting
Saint Thomas Hospital
Panama City, Provincia de Panamá
Osvaldo A Reyes, MD, o11(507)65655041, oreyespanama@yahoo.es
About this study
Official title: Usefulness of 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.
Read more
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
- Being tested
- Lung ultrasound
- Keywords
- Pulmonary edema, Severe preeclampsia, B lines, Lung ultrasound
- Medical subject headings
- Pre-Eclampsia, Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Lung ultrasounf at three moments (at admission, before delivery and immediate post partum) to determine B Lines
| Study group | Role | What they receive |
|---|---|---|
| Severe preeclampsia | Experimental | Pregnant subjects (24 weeks - 41 weeks) with severe preeclampsia Receives: Diagnostic Test: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Ultrasound evaluation
Three or more B Lines in at least two lung zones using lung ultrasound
Measured: One evaluation at admission, another one just before delivery and a final one 24 hours after delivery
Secondary outcomes (3)
Dyspnea
Subjective sensation of difficulty breathing
Measured: Report of the symptom by the patient from admission for up to three days
Tachypnea
Respiratory rate above 20 breaths/min
Measured: Report of the symptom from admission for up to three days.
Oxygen saturation
Oxygen saturation measured by pulse oxymeter
Measured: Report of the value measured by a pulse oxymeter from admission for up to three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start25 Aug 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Edema - AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Study director, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261956
- Sponsor's protocol ID
- 4377
- Status last verified
- Nov 2025
- First submitted
- 24 Aug 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No