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RecruitingNCT07261956Updated Dec 3, 2025

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

An interventional study of Lung ultrasound in Pulmonary Edema - Acute and Preeclampsia, sponsored by Saint Thomas Hospital, Panama. Recruiting at 1 site in Panama. Open to female participants. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Saint Thomas Hospital, Panama · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
202
Allocation
Not applicable
Sex
Female
01

Study 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.

02

Conditions studied

  • Pulmonary Edema - Acute
  • Preeclampsia

Keywords

  • Pulmonary edema
  • Severe preeclampsia
  • B lines
  • Lung ultrasound
03

In context

Pre-Eclampsia

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 202 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Saint Thomas Hospital, Panama is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Chronic lung disease.
  • Known heart disease.
  • Diagnosis of lung edema at admission
  • > 40
  • Need for immediate delivery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
202 participants (estimated)

Study arms

  • Experimental
    Severe preeclampsia

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

    Diagnostic Test: Lung ultrasound

Interventions

  • Diagnostic testLung ultrasound

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Saint Thomas Hospital
    Panama City, Provincia de Panamá, Panama
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Dec 2025, 4 months after the start.

Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 4 months is below that.

Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 24, 2025
First posted
Dec 3, 2025
StartActual
Aug 25, 2025
Primary completionEst.
Dec 31, 2025
CompletionEst.
Jan 31, 2026
Last update
Dec 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07261956
Lead sponsor
Saint Thomas Hospital, Panama
Responsible party
Osvaldo A. Reyes T. (Head of Research Department, Saint Thomas Hospital, Panama) — Principal investigator
First posted
Dec 3, 2025
Start date
Aug 25, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Dec 3, 2025

Study contacts

Anna C Figueroa, MD
Contact
annacfigue@gmail.com
+507 69494250
Adriana Martinz, MD
Contact
amartinzmd@gmail.com
Osvaldo Reyes, MD
study director · Saint Thomas Hospital, Panama

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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