Pulmonary Edema Resolution in Severe Preeclampsia and Eclampsia
- Conditions
- Severe Pre-eclampsiaEclampsia
- Registration Number
- NCT06219109
- Lead Sponsor
- Doctors with Africa - CUAMM
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 55
- All patients with severe pre-eclampsia or eclampsia admitted to hospital Princess Christian Maternity Hospital
- 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,
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of LUS consistent with pulmonary edema during hospital stay, average of 1 month Frequency endpoint: proportion of patients with a LUS positive for pulmonary edema Severity: LUS aeration score
Timing of resolution after delivery during hospital stay, average of 1 month Categorical: Fraction of patients with improvement or resolution of LUS findings.
Numerical: delta LUS score between T1 and T2
- Secondary Outcome Measures
Name Time Method Frequency of Indirect Obstetric complications during hospital stay, average of 1 month Fraction of patients with at least one among stroke, severe malaria, acute kidney injury and cardiac insufficiency.
Frequency of other LUS findings during hospital stay, average of 1 month Proportion of patients with
* consolidations
* isolated pleural effusion
* minor LUS findingsFrequency of perinatal complications during hospital stay, average of 1 month Intra uterine fetal death (IUFD), Apgar score, Admission to special care baby unit (SCBU)
Frequency of acute respiratory failure in patients with Severe Pre eclampsia and in patients with Eclampsia during hospital stay, average of 1 month Proportion of patients with acute respiratory failure
Oxygenation assessment during hospital stay, average of 1 month SpO2 (peripheral capillary oxygen saturation) to FiO2 (fraction of inspired oxygen) ratio
Frequency of Major Direct Obstetric Complications (MDOCs) during hospital stay, average of 1 month Fraction of patients with at least one additional MDOC (antepartum hemorrhage, postpartum hemorrhage, sepsis, uterine rupture, obstructed labour)
Frequency of organ support strategies during hospital stay, average of 1 month Fraction of patients that receive oxygen and/or CPAP (Continuous Positive Airway Pressure) and/or mechanical ventilation
Frequency of patients with abnormal cardiac function during hospital stay, average of 1 month Defined as low cardiac index measured by ultrasound
Trial Locations
- Locations (1)
Princess Christian Maternity Hospital
🇸🇱Freetown, Sierra Leone