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Pulmonary Edema Resolution in Severe Preeclampsia and Eclampsia

SeveriTy of Pulmonary Edema and Timing of Resolution in Patients With Severe Pre-eclampsia and Eclampsia (TIPER): A Physiological and Sonographic Prospective Observational Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06219109
Acronym
TiPER
Enrollment
55
Registered
2024-01-23
Start date
2023-05-08
Completion date
2024-04-02
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eclampsia, Severe Pre-eclampsia

Keywords

Eclampsia, Preeclampsia, Lung ultrasound scan, Pulmonary oedema, Respiratory distress

Brief summary

Patients with severe preeclampsia or eclampsia suffer from pulmonary complications. Accurate assessment of patients with pulmonary involvement using lung ultrasound (LUS) and echocardiography could lead to earlier detection of pre eclampsia and eclampsia associated pulmonary oedema, ARDS (acute respiratory distress syndrome) and other pulmonary complications. here is currently limited evidence regarding the features, severity, aetiology and history of pulmonary oedema in this group of patients Data from this prospective observational study will facilitate the early recognition of pre-eclamptic and eclamptic patients with pulmonary involvement to implement optimal triage and early therapeutic choices in a limited resource setting (diuretics, escalation to non invasive or invasive ventilation, referral to HDU (High dependency unit) or ICU, dialysis) and potentially reduce unfavorable outcomes.

Detailed description

Background - Maternal mortality from treatable causes concerning the critical care domain in low- income countries remains strikingly high. Maternal mortality in Sierra Leone is the highest in the world with 1,360 deaths per 100,000 born alive. The burden of obstetric-related critical care morbidity is also extremely high. In high-income countries less than 2% of intensive care unit admissions relate to obstetric illnesses, but these rise to 10% in resource-limited settings. Pre-eclampsia/eclampsia are hypertensive disorders of pregnancy, one of the 3 leading causes of maternal morbidity and mortality worldwide. Respiratory distress and pulmonary oedema are known complications of preeclampsia-eclampsia and their insurgence is a hallmark of severe disease. Pulmonary oedema is reported as a complication in 2.9% of patients with preeclampsia-eclampsia. Pulmonary involvement is associated with worse maternal and perinatal outcomes. Incidence is significantly higher in low income countries, rising to 12% due to poorer prenatal care and access to hospital care, and suboptimal diagnostic and management processes . Aim - The primary aim is to describe the frequency of lung ultrasound consistent with pulmonary oedema and the timing of resolution after delivery. Secondary aims include the assessment of the frequency of acute respiratory failure, other LUS findings beyond pulmonary edema, the assessment of oxygenation, the use of respiratory organ support strategies, assessment of cardiac function, and quantification of major direct/ indirect obstetric complications and of perinatal complications. Hypothesis - 1. A high proportion (\>20%) of patients show LUS signs consistent with pulmonary edema before delivery. 2. There is incomplete resolution of both clinical and ultrasound signs after in the 72 hours after delivery. Setting - Princess Christian Maternity Hospital, Freetown, Sierra Leone Population - Female subjects, hospitalized with severe preeclampsia or eclampsia Methods - Single centre, prospective, cohort study of patients with severe pre-eclampsia and eclampsia. The expected duration of study is 1 year. All patients with suspected severe pre-eclampsia or eclampsia will undergo screening upon admission to HDU and the Eclamptic ward. Eligible patients will undergo a systematic clinical and LUS examination, straight after admission (before delivery). Clinical examination will focus on signs of respiratory, neurologic and cardiac failure. Lung ultrasound will be performed using a Butterfly ultrasound probe (Butterfly, USA). Lung ultrasound will be performed using the validated 12-region method. As heart failure is a common finding in preeclamptic women, echocardiography performed with a cardiac sector probe, will enable real-time assessment of maternal cardiac contractility and cardiac output. The same clinical, LUS and echocardiographic assessment will be repeated between 24 h to 72 h (after delivery). Whenever the pre-delivery timepoint is not feasible due to late arrival, emergency scenario or postpartum onset, the after delivery examination only will be performed.

Interventions

None listed

Sponsors

Doctors with Africa - CUAMM
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

\- All patients with severe pre-eclampsia or eclampsia admitted to hospital Princess Christian Maternity Hospital

Exclusion criteria

* Patients with chronic hypertensive disorders * Lung ultrasound not feasible, e.g., due to electricity breakdown, or absence of the trained sonographer or presence of subcutaneous emphysema,

Design outcomes

Primary

MeasureTime frameDescription
Frequency of LUS consistent with pulmonary edemaduring hospital stay, average of 1 monthFrequency endpoint: proportion of patients with a LUS positive for pulmonary edema Severity: LUS aeration score
Timing of resolution after deliveryduring hospital stay, average of 1 monthCategorical: Fraction of patients with improvement or resolution of LUS findings. Numerical: delta LUS score between T1 and T2

Secondary

MeasureTime frameDescription
Frequency of organ support strategiesduring hospital stay, average of 1 monthFraction of patients that receive oxygen and/or CPAP (Continuous Positive Airway Pressure) and/or mechanical ventilation
Frequency of patients with abnormal cardiac functionduring hospital stay, average of 1 monthDefined as low cardiac index measured by ultrasound
Oxygenation assessmentduring hospital stay, average of 1 monthSpO2 (peripheral capillary oxygen saturation) to FiO2 (fraction of inspired oxygen) ratio
Frequency of acute respiratory failure in patients with Severe Pre eclampsia and in patients with Eclampsiaduring hospital stay, average of 1 monthProportion of patients with acute respiratory failure
Frequency of Indirect Obstetric complicationsduring hospital stay, average of 1 monthFraction of patients with at least one among stroke, severe malaria, acute kidney injury and cardiac insufficiency.
Frequency of perinatal complicationsduring hospital stay, average of 1 monthIntra uterine fetal death (IUFD), Apgar score, Admission to special care baby unit (SCBU)
Frequency of Major Direct Obstetric Complications (MDOCs)during hospital stay, average of 1 monthFraction of patients with at least one additional MDOC (antepartum hemorrhage, postpartum hemorrhage, sepsis, uterine rupture, obstructed labour)
Frequency of other LUS findingsduring hospital stay, average of 1 monthProportion of patients with * consolidations * isolated pleural effusion * minor LUS findings

Countries

Sierra Leone

Contacts

Primary ContactSerena Crisci
serena.crisci@virgilio.it+393387237228

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026