EclampsiaTiPERNCT06219109
Pulmonary Edema Resolution in Severe Preeclampsia and Eclampsia
An observational study of Eclampsia and Severe Pre-eclampsia, run by Doctors with Africa - CUAMM at 1 site in Sierra Leone.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Eclampsia, Severe Pre-eclampsia
- How many people
- 55 participants
- Where
- 1 siteSierra Leone
- Study dates
- 8 May 2023to 2 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized at PCMH with severe preclampsia and eclampsia will be enrolled if the applicable inclusion and exclusion criteria are met
Who may be able to join
- All patients with severe pre-eclampsia or eclampsia admitted to hospital Princess Christian Maternity Hospital
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Sierra Leone1 site, 1 recruiting
- Recruiting
Princess Christian Maternity Hospital
Freetown
Momoh Sitta Turay, +23278682722, m.turay@cuamm.org
About this study
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
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.
Read the 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 -
- A high proportion (>20%) of patients show LUS signs consistent with pulmonary edema before delivery.
- 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.
- Conditions
- Eclampsia, Severe Pre-eclampsia
- Keywords
- Eclampsia, Preeclampsia, Lung ultrasound scan, Pulmonary oedema, Respiratory distress
- Medical subject headings
- Eclampsia, Pre-Eclampsia, Pulmonary Edema, Dyspnea
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of LUS consistent with pulmonary edema
Frequency endpoint: proportion of patients with a LUS positive for pulmonary edema Severity: LUS aeration score
Measured: 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
Measured: during hospital stay, average of 1 month
Secondary outcomes (8)
Frequency of acute respiratory failure in patients with Severe Pre eclampsia and in patients with Eclampsia
Proportion of patients with acute respiratory failure
Measured: during hospital stay, average of 1 month
Frequency of other LUS findings
Proportion of patients with
- consolidations
- isolated pleural effusion
- minor LUS findings
Measured: 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
Measured: during hospital stay, average of 1 month
Frequency of patients with abnormal cardiac function
Defined as low cardiac index measured by ultrasound
Measured: during hospital stay, average of 1 month
Oxygenation assessment
SpO2 (peripheral capillary oxygen saturation) to FiO2 (fraction of inspired oxygen) ratio
Measured: 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)
Measured: 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.
Measured: 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)
Measured: during hospital stay, average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start8 May 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion2 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doctors with Africa - CUAMM
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Pisani, Principal investigator, Doctors with Africa - CUAMMAdeniji Adetunji Oladeni, Principal investigator, University of Sierra Leone Teaching Hospitals Complex, Princess Christian Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219109
- Sponsor's protocol ID
- Cuamm_02/23
- Acronym
- TiPER
- Status last verified
- Jan 2024
- First submitted
- 8 Sep 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06219109
- Acronym / sponsor ID
- TiPER / Cuamm_02/23
- Conditions
- Eclampsia, Severe Pre-eclampsia
- Keywords
- Eclampsia, Preeclampsia, Lung ultrasound scan, Pulmonary oedema, Respiratory distress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Doctors with Africa - CUAMMUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 2 Apr 2024 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 -
- A high proportion (>20%) of patients show LUS signs consistent with pulmonary edema before delivery.
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized at PCMH with severe preclampsia and eclampsia will be enrolled if the applicable inclusion and exclusion criteria are met
Key inclusion criteria (1 listed)
- All patients with severe pre-eclampsia or eclampsia admitted to hospital Princess Christian Maternity Hospital
Key exclusion criteria (2 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of LUS consistent with pulmonary edema
Time frame: 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
Time frame: 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
8 secondary outcomes
Frequency of acute respiratory failure in patients with Severe Pre eclampsia and in patients with Eclampsia
Time frame: during hospital stay, average of 1 month
Frequency of other LUS findings
Time frame: during hospital stay, average of 1 month
Frequency of organ support strategies
Time frame: during hospital stay, average of 1 month
Frequency of patients with abnormal cardiac function
Time frame: during hospital stay, average of 1 month
Oxygenation assessment
Time frame: during hospital stay, average of 1 month
Frequency of Major Direct Obstetric Complications (MDOCs)
Time frame: during hospital stay, average of 1 month
Frequency of Indirect Obstetric complications
Time frame: during hospital stay, average of 1 month
Frequency of perinatal complications
Time frame: during hospital stay, average of 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Pisani principal investigator
Doctors with Africa - CUAMM
Adeniji Adetunji Oladeni principal investigator
University of Sierra Leone Teaching Hospitals Complex, Princess Christian Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eclampsia and Severe Pre-eclampsia, run by Doctors with Africa - CUAMM at 1 site in Sierra Leone.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sierra Leone. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serena Crisci (+393387237228, serena.crisci@virgilio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of LUS consistent with pulmonary edema (time frame: during hospital stay, average of 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.