Clinical trial NCT06219109: Pulmonary Edema Resolution in Severe Preeclampsia and Eclampsia
Official title: SeveriTy of Pulmonary Edema and Timing of Resolution in Patients With Severe Pre-eclampsia and Eclampsia (TIPER): A Physiological and Sonographic Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Eclampsia
Severe Pre-eclampsia
Keywords: Eclampsia
Preeclampsia
Lung ultrasound scan
Pulmonary oedema
Respiratory distress
Lead sponsor: Doctors with Africa - CUAMM
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 55
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized at PCMH with severe preclampsia and eclampsia will be enrolled if the applicable inclusion and exclusion criteria are met

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.

Eligibility criteria: 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,

Primary outcomes:
measure: Frequency of LUS consistent with pulmonary edema
timeFrame: during hospital stay, average of 1 month
measure: Timing of resolution after delivery
timeFrame: during hospital stay, average of 1 month
Secondary outcomes:
measure: Frequency of acute respiratory failure in patients with Severe Pre eclampsia and in patients with Eclampsia
timeFrame: during hospital stay, average of 1 month
measure: Frequency of other LUS findings
timeFrame: during hospital stay, average of 1 month
measure: Frequency of organ support strategies
timeFrame: during hospital stay, average of 1 month
measure: Frequency of patients with abnormal cardiac function
timeFrame: during hospital stay, average of 1 month
measure: Oxygenation assessment
timeFrame: during hospital stay, average of 1 month
measure: Frequency of Major Direct Obstetric Complications (MDOCs)
timeFrame: during hospital stay, average of 1 month
measure: Frequency of Indirect Obstetric complications
timeFrame: during hospital stay, average of 1 month
measure: Frequency of perinatal complications
timeFrame: during hospital stay, average of 1 month
Other outcomes:
Locations:
city: Freetown
country: Sierra Leone
facility: Princess Christian Maternity Hospital
Study officials:
affiliation: Doctors with Africa - CUAMM
name: Luigi Pisani
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sierra Leone Teaching Hospitals Complex, Princess Christian Maternity Hospital
name: Adeniji Adetunji Oladeni
role: PRINCIPAL_INVESTIGATOR
References: