Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia

December 21, 2022 updated by: Robert Dyer, University of Cape Town

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

The study is planned to describe the prevalence and severity of cardiac, lung and optic-nerve sheath diameter (ONSD) ultrasound abnormalities in women with early onset preeclampsia with severe features. These findings will be compared with point-of-care ultrasound (POCUS) abnormalities demonstrated in our recent study on late onset preeclampsia. The primary aim of the current study will be to examine the association between pulmonary interstitial edema (PIS), as identified by lung ultrasound, and cardiac dysfunction on echocardiography, and brain natriuretic peptide (BNP), in early onset preeclampsia, after comprehensive echocardiographic assessment. The secondary aims are to assess ONSD, and to explore the association between PIS or ONSD and serum albumin. A further secondary aim will be to explore the association between POCUS abnormalities and cardiotocography abnormalities and early delivery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Preeclampsia (PE) remains a leading cause of maternal morbidity and mortality, in both high-, low and-middle-income countries. It is a complex, multisystem disease which, in its severe form, affects the cardiovascular, renal, hepatic, neurological and haematological systems. The University of Cape Town-associated medical institutions alone were responsible for the treatment of approximately 800 women in 2019, who were classified as having PE with severe features. Recent studies have demonstrated novel markers of severity of PE, including point-of-care ultrasound (POCUS), acid-base changes secondary to low serum albumin, and brain natriuretic peptide (BNP). A study conducted at Mowbray Maternity Hospital in Cape Town, South Africa, showed that approximately 59% of women had an abnormality shown by POCUS; 24% had elevated lung water (pulmonary interstitial syndrome [PIS]). These findings could serve as non-invasive markers of disease severity, and thus may be used to predict maternal and fetal outcome in preeclamptic women. POCUS is playing an increasing role in perioperative diagnosis, and newer, less expensive devices are continuously being developed. These will in all likelihood play an important role in South Africa in the near future. In a recent trial performed at the University of Cape Town, a comprehensive acid-base analysis in women with PE with severe features demonstrated significant abnormalities in independent acid-base determinants. In addition, strong indications were found that changes in acid-base status following a decrease in serum albumin are more pronounced in early onset PE, and may be associated with urgent delivery. In other clinical arenas in critically ill patients, low serum albumin is associated with increased lung water, increased intracranial pressure, and outcome. The study team hypothesised that similar associations might be found in women with late onset preeclampsia with severe features. Using POCUS, it was found that there was no association between serum albumin level and PIS or optic nerve sheath diameter (ONSD). PIS was however associated with cardiac dysfunction, as was BNP. This study is planned to describe the prevalence of pulmonary (PIS), cardiac and optic nerve sheath abnormalities found on ultrasound in women diagnosed with early onset PE with severe features. In a recent study on POCUS findings in late onset preeclampsia, the absence of PIS may exclude raised LVEDP. As a consequence, the primary aim of the current study is to examine the association between PIS, as identified by lung ultrasound and cardiac dysfunction on echocardiography, and BNP, in early onset PE. For this purpose, a comprehensive echocardiographic assessment will be performed. The secondary aims are to explore the association between PIS or ONSD and serum albumin. These findings will be compared with POCUS abnormalities demonstrated in our recent study on late onset PE. In addition, the association will be explored between POCUS abnormalities and CTG abnormalities and early delivery. Using a prospective observational cohort design, patients diagnosed with early onset PE with severe features will be enrolled. If agreeable to participate in the study, a venous blood sample will be taken for the measurement of serum BNP and serum albumin level, followed by a 25-30 minute non-invasive lung, cardiac and optic nerve ultrasound examination. The risks posed to the patients involved in this study are minimal. Discomfort may be experienced due to the sampling of blood, however these will be performed as part of the routine blood sampling in patients with PE. All ultrasound interventions are non-invasive. Patients not included in the study will not be disadvantaged in any way, as no treatment interventions are being proposed. All study participants will be clinically managed by the attending obstetrics team and collaborative involvement with the team will ensure current management standards at the Maternity Centre at Groote Schuur Hospital in Cape Town are maintained. Thus, the 25-30 minute ultrasound examination will not interfere with or compromise standard healthcare to recruited study participants. This observational study carries minimal risk and has the potential to fill a major knowledge gap in the role of ultrasound in the anaesthesia care of preeclamptic patients. This should be of significant future benefit in the South African context, where PE is a leading cause of maternal mortality and pulmonary oedema is a main contributor.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1. Patients diagnosed and admitted with early onset preeclampsia with severe features

Exclusion Criteria:

  1. Body mass index (BMI) > 50 kg/m2
  2. Clinical evidence of pulmonary oedema
  3. The presence of a non-reassuring fetal heart trace
  4. Active labour
  5. Chronic pulmonary disease, or acute asthma
  6. Collagen disorders
  7. Chronic renal or hepatic disease
  8. Urinary tract infection
  9. Chorioamnionitis
  10. Intrauterine fetal death
  11. Patients unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / 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

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

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

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Robert Dyer, MBChB, PhD, University of Cape Town

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Actual)

December 23, 2022

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • POCUS in early preeclampsia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD

IPD Sharing Time Frame

6 months following publication.

IPD Sharing Access Criteria

Any researchers, and clinicians or healthcare workers continuing care of the participants after the study, as well as the participants themselves.

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

No

Studies a U.S. FDA-regulated device product

No

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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