NCT06219109

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

September 8, 2023

Last Update Submit

January 19, 2024

Conditions

EclampsiaSevere Pre-eclampsia

Keywords

EclampsiaPreeclampsiaLung ultrasound scanPulmonary oedemaRespiratory distress

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

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

    during hospital stay, average of 1 month

  • Frequency of other LUS findings

    during hospital stay, average of 1 month

  • Frequency of organ support strategies

    during hospital stay, average of 1 month

  • Frequency of patients with abnormal cardiac function

    during hospital stay, average of 1 month

  • Oxygenation assessment

    during hospital stay, average of 1 month

  • +3 more secondary outcomes

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients hospitalized at PCMH with severe preclampsia and eclampsia will be enrolled if the applicable inclusion and exclusion criteria are met

You may qualify if:

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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Christian Maternity Hospital

Freetown, Sierra Leone

RECRUITING

MeSH Terms

Conditions

EclampsiaPre-EclampsiaPulmonary EdemaDyspnea

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luigi Pisani

    Doctors with Africa - CUAMM

    PRINCIPAL INVESTIGATOR

  • Adeniji Adetunji Oladeni

    University of Sierra Leone Teaching Hospitals Complex, Princess Christian Maternity Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serena Crisci

CONTACT

+393387237228serena.crisci@virgilio.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

January 23, 2024

Study Start

May 8, 2023

Primary Completion

April 1, 2024

Study Completion

April 2, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

SI(1)