Pulmonary Edema Resolution in Severe Preeclampsia and Eclampsia (TiPER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Eclampsia; Severe Pre-eclampsia

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.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Serena Crisci; Phone Number: +393387237228; Email: serena.crisci@virgilio.it

Study Locations

• Sierra Leone
  • Freetown, Sierra Leone
    • Recruiting
    • Princess Christian Maternity Hospital
    • Contact: Momoh Sitta Turay; Phone Number: +23278682722; Email: m.turay@cuamm.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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,

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of LUS consistent with pulmonary edema	Frequency endpoint: proportion of patients with a LUS positive for pulmonary edema Severity: LUS aeration score	during hospital stay, average of 1 month
Timing of resolution after delivery	Categorical: Fraction of patients with improvement or resolution of LUS findings. Numerical: delta LUS score between T1 and T2	during hospital stay, average of 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of acute respiratory failure in patients with Severe Pre eclampsia and in patients with Eclampsia	Proportion of patients with acute respiratory failure	during hospital stay, average of 1 month
Frequency of other LUS findings	Proportion of patients with; consolidations; isolated pleural effusion; minor LUS findings	during hospital stay, average of 1 month
Frequency of organ support strategies	Fraction of patients that receive oxygen and/or CPAP (Continuous Positive Airway Pressure) and/or mechanical ventilation	during hospital stay, average of 1 month
Frequency of patients with abnormal cardiac function	Defined as low cardiac index measured by ultrasound	during hospital stay, average of 1 month
Oxygenation assessment	SpO2 (peripheral capillary oxygen saturation) to FiO2 (fraction of inspired oxygen) ratio	during hospital stay, average of 1 month
Frequency of Major Direct Obstetric Complications (MDOCs)	Fraction of patients with at least one additional MDOC (antepartum hemorrhage, postpartum hemorrhage, sepsis, uterine rupture, obstructed labour)	during hospital stay, average of 1 month
Frequency of Indirect Obstetric complications	Fraction of patients with at least one among stroke, severe malaria, acute kidney injury and cardiac insufficiency.	during hospital stay, average of 1 month
Frequency of perinatal complications	Intra uterine fetal death (IUFD), Apgar score, Admission to special care baby unit (SCBU)	during hospital stay, average of 1 month

Collaborators and Investigators

• Sponsor: Doctors with Africa - CUAMM
• Investigators: Principal Investigator: Luigi Pisani, Doctors with Africa - CUAMM; Principal Investigator: Adeniji Adetunji Oladeni, University of Sierra Leone Teaching Hospitals Complex, Princess Christian Maternity Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 2, 2024

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Estimated): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Respiratory distress; Preeclampsia; Eclampsia; Lung ultrasound scan; Pulmonary oedema
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eclampsia; Pre-Eclampsia; Pulmonary Edema
• Other Study ID Numbers: Cuamm_02/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No