Point-of-care Ultrasound Abnormalities in Early Onset Preeclampsia

NCT05662995 | Unknown

• 1 other identifier: POCUS in early preeclampsia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preeclampsia; Pulmonary Edema; Cardiac Function

Outcome Measures

Primary Outcomes (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.

  35-40 minutes

Secondary Outcomes (2)

• The association between pulmonary interstitial syndrome or optic nerve sheath diameter, and serum albumin

  35-40 minutes.

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

  35-40 minutes

Study Arms (1)

Lung- and cardiac ultrasound, as well as optic nerve sheath diameter.

EXPERIMENTAL

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

Diagnostic Test: Lung ultrasound

Interventions

Lung ultrasound DIAGNOSTIC_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

Lung- and cardiac ultrasound, as well as optic nerve sheath diameter.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead
• Stanford University: collaborator

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7599, South Africa

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia; Pulmonary Edema

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Dyer, MBChB, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margot Flint, PhD

CONTACT

+27214045144; margot.flint@uct.ac.za

Robert Dyer, MBChB; PhD

CONTACT

+27214045001

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Robert Dyer

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 23, 2022
• Study Start: November 28, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 6 months following publication.
• Access Criteria: Any researchers, and clinicians or healthcare workers continuing care of the participants after the study, as well as the participants themselves.

Locations

ZA (1)