Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia
Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia - Prevalence and Association Between Pulmonary Interstitial Syndrome and Cardiac Dysfunction, Brain Natriuretic Peptide, and Serum Albumin
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Margot Flint, PhD
- Phone Number: +27214045144
- Email: margot.flint@uct.ac.za
Study Contact Backup
- Name: Robert Dyer, MBChB; PhD
- Phone Number: +27214045001
Study Locations
-
-
Western Cape
-
Cape Town, Western Cape, South Africa, 7599
- Recruiting
- Groote Schuur Hospital
-
Contact:
- Margot Flint, PhD
- Phone Number: +2721 4045001
- Email: margot.flint@uct.ac.za
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Patients diagnosed and admitted with early onset preeclampsia with severe features
Exclusion Criteria:
- Body mass index (BMI) > 50 kg/m2
- Clinical evidence of pulmonary oedema
- The presence of a non-reassuring fetal heart trace
- Active labour
- Chronic pulmonary disease, or acute asthma
- Collagen disorders
- Chronic renal or hepatic disease
- Urinary tract infection
- Chorioamnionitis
- Intrauterine fetal death
- Patients unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Lung- and cardiac ultrasound, as well as optic nerve sheath diameter.
An ultrasound examination (approximately 25-30 minutes in duration) will be performed at the time of venous blood sampling on admission.
The examination will consist of an assessment of systolic and diastolic function, lung ultrasound, and measurement of the optic nerve sheath diameter
|
Lung ultrasound will be performed with the patient in supine position (with or without left uterine displacement, depending on clinical circumstances).
A phased-array transducer will be used for lung ultrasound and will be used for the assessment of B-lines, which arise from the pleural line and extend to the bottom of the screen and move with the sliding lung
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The association between pulmonary interstitial syndrome and cardiac dysfunction on echocardiography
Time Frame: 35-40 minutes
|
More than 3 B-lines in 2 lung windows bilaterally defines the presence of pulmonary interstitial syndrome. Cardiac dysfunction on echocardiography is defined as raised left ventricular end-diastolic pressure as demonstrated on echocardiography. |
35-40 minutes
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The association between pulmonary interstitial syndrome or optic nerve sheath diameter, and serum albumin
Time Frame: 35-40 minutes.
|
Please see description for outcome 1 for pulmonary interstitial syndrome.
Abnormal optic nerve sheath diameter is defined as greater than 5.8 mm.
Brain natriuretic peptide and serum albumin are continuous variables.
|
35-40 minutes.
|
|
The prevalence and severity of cardiac, lung and optic nerve sheath diameter abnormalities in women with early onset PE
Time Frame: 35-40 minutes
|
Please see definitions as described under Outcome 1 and Outcome 2.
|
35-40 minutes
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Robert Dyer, MBChB, PhD, University of Cape Town
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- POCUS in early preeclampsia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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