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RecruitingNCT06219109TiPERUpdated Jan 23, 2024

Pulmonary Edema Resolution in Severe Preeclampsia and Eclampsia

An observational study in Eclampsia and Severe Pre-eclampsia, sponsored by Doctors with Africa - CUAMM. Recruiting at 1 site in Sierra Leone. Open to female participants. Per ClinicalTrials.gov, last updated 2024-01-23.

Sponsored by Doctors with Africa - CUAMM · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
55
Sex
Female
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Study 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.

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 -

  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.

02

Conditions studied

  • Eclampsia
  • Severe Pre-eclampsia

Keywords

  • Eclampsia
  • Preeclampsia
  • Lung ultrasound scan
  • Pulmonary oedema
  • Respiratory distress
03

In context

Eclampsia

76 studies on the registry are indexed under Eclampsia; 13 are open to participants now.

This study's planned enrollment of 55 is below the median of 282 across 34 observational studies indexed under Eclampsia.

Browse Eclampsia studies →

Lead sponsor

Doctors with Africa - CUAMM is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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,
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
55 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Frequency of LUS consistent with pulmonary edema

    Frequency endpoint: proportion of patients with a LUS positive for pulmonary edema Severity: LUS aeration score

    Time frame: during hospital stay, average of 1 month

  2. Timing of resolution after delivery

    Categorical: Fraction of patients with improvement or resolution of LUS findings. Numerical: delta LUS score between T1 and T2

    Time frame: during hospital stay, average of 1 month

Secondary outcomes

  1. Frequency of acute respiratory failure in patients with Severe Pre eclampsia and in patients with Eclampsia

    Proportion of patients with acute respiratory failure

    Time frame: during hospital stay, average of 1 month

  2. Frequency of other LUS findings

    Proportion of patients with * consolidations * isolated pleural effusion * minor LUS findings

    Time frame: during hospital stay, average of 1 month

  3. Frequency of organ support strategies

    Fraction of patients that receive oxygen and/or CPAP (Continuous Positive Airway Pressure) and/or mechanical ventilation

    Time frame: during hospital stay, average of 1 month

  4. Frequency of patients with abnormal cardiac function

    Defined as low cardiac index measured by ultrasound

    Time frame: during hospital stay, average of 1 month

  5. Oxygenation assessment

    SpO2 (peripheral capillary oxygen saturation) to FiO2 (fraction of inspired oxygen) ratio

    Time frame: during hospital stay, average of 1 month

  6. 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)

    Time frame: during hospital stay, average of 1 month

  7. Frequency of Indirect Obstetric complications

    Fraction of patients with at least one among stroke, severe malaria, acute kidney injury and cardiac insufficiency.

    Time frame: during hospital stay, average of 1 month

  8. Frequency of perinatal complications

    Intra uterine fetal death (IUFD), Apgar score, Admission to special care baby unit (SCBU)

    Time frame: during hospital stay, average of 1 month

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Study locations

1 of 1 sites recruiting
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Apr 2024, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2023
First posted
Jan 23, 2024
StartActual
May 8, 2023
Primary completionEst.
Apr 1, 2024
CompletionEst.
Apr 2, 2024
Last update
Jan 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06219109
Lead sponsor
Doctors with Africa - CUAMM
Responsible party
Sponsor
First posted
Jan 23, 2024
Start date
May 8, 2023
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 2, 2024 (estimated)
Last update
Jan 23, 2024

Study contacts

Serena Crisci
Contact
serena.crisci@virgilio.it
+393387237228
Luigi Pisani
principal investigator · Doctors with Africa - CUAMM
Adeniji Adetunji Oladeni
principal investigator · University of Sierra Leone Teaching Hospitals Complex, Princess Christian Maternity Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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