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PreeclampsiaNCT05662995

Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia

A study testing Lung ultrasound in people with Preeclampsia and Pulmonary Edema, run by University of Cape Town at 1 site in South Africa.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Preeclampsia, Pulmonary Edema, Cardiac Function
What is being tested?
Lung ultrasound
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Africa
Study dates
28 Nov 2022to 1 Dec 2023
Phase
Interventional
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 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • Chronic renal or hepatic disease
  • Urinary tract infection
  • Chorioamnionitis
  • Intrauterine fetal death
  • Patients unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

Margot Flint, PhD contact

+27214045144

margot.flint@uct.ac.za

Robert Dyer, MBChB; PhD contact

+27214045001

South Africa1 site, 1 recruiting
  • Groote Schuur Hospital

    Cape Town, Western Cape, 7599

    Margot Flint, PhD, +2721 4045001, margot.flint@uct.ac.za

    Recruiting

Other trials in South Africa

About this study

Official title: 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.

Read the 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.

Being tested
Lung ultrasound
Medical subject headings
Pre-Eclampsia, Pulmonary Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung ultrasoundDiagnostic test

    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

Study groups in NCT05662995
Study groupRoleWhat they receive
Lung- and cardiac ultrasound, as well as optic nerve sheath diameter.ExperimentalAn 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
Receives: Diagnostic Test: Lung ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The association between pulmonary interstitial syndrome and cardiac dysfunction on echocardiography

    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.

    Measured: 35-40 minutes

Secondary outcomes (2)
  1. The association between pulmonary interstitial syndrome or optic nerve sheath diameter, and serum albumin

    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.

    Measured: 35-40 minutes.

  2. The prevalence and severity of cardiac, lung and optic nerve sheath diameter abnormalities in women with early onset PE

    Please see definitions as described under Outcome 1 and Outcome 2.

    Measured: 35-40 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start28 Nov 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05662995
Sponsor's protocol ID
POCUS in early preeclampsia
Status last verified
Dec 2022
First submitted
22 Nov 2022
Last updated
23 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected IPD

Questions about this trial

What is this clinical trial studying?

A study testing Lung ultrasound in people with Preeclampsia and Pulmonary Edema, run by University of Cape Town at 1 site in South Africa.

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 11 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 Dec 2022. 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 South Africa. 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 Margot Flint, PhD (+27214045144, margot.flint@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The association between pulmonary interstitial syndrome and cardiac dysfunction on echocardiography (time frame: 35-40 minutes). 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 Dec 2022.

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