Point-of-care Ultrasound Abnormalities in Eclampsia

NCT05678062 | Recruiting

• 1 other identifier: POCUS in eclampsia
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia (PE) and eclampsia remain leading causes of maternal morbidity and mortality, in both high-, low-and-middle-income countries. Preeclampsia is a complex, multisystem disease which, in its severe form, affects the cardiovascular, renal, hepatic, neurological and haematological systems. Given the complexity of the disease, anaesthesia management for caesarean section in these patients remains challenging. Preeclampsia may be complicated by the development of eclampsia, which involves one or more seizures, which complicates anaesthesia and obstetrics management, and requires. urgent admission and delivery. 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). 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 research 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.

Conditions

Eclampsia

Keywords

Pulmonary interstitial syndrome; Cardiac dysfunction; Brain natriuretic peptide

Outcome Measures

Primary Outcomes (1)

• The correlation between pulmonary interstitial syndrome (as identified by lung ultrasound), and cardiac dysfunction on echocardiography, in eclamptic women

  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 correlation between pulmonary interstitial syndrome and optic nerve sheath diameter, serum brain natriuretic peptide and albumin

  35-40 minutes

• The prevalence of cardiac, lung and optic nerve sheath ultrasound

  35-40 minutes

Study Arms (1)

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

OTHER

Maternal ultrasound examinations will be performed after normal obstetric treatment protocols have been completed, i.e., the conduction of the study will contribute no delay in routine or emergency patient management. Ultrasound examination will be repeated after 72-96 hours, subject to the same conditions. An ultrasound examination (approximately 35-40 minutes in duration) will be performed. The ultrasound examination will consist of evaluation of lung- and cardiac ultrasound, as well as optic nerve sheath diameter.

Diagnostic Test: Point-of-care ultrasound

Interventions

Point-of-care ultrasound DIAGNOSTIC_TEST

An ultrasound examination (approximately 35-40 minutes in duration) will be performed. The ultrasound examination will consist of evaluation of lung- and cardiac ultrasound, as well as optic nerve sheath diameter.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of preeclampsia following ACOG definition with new onset of tonic-clonic seizures.

You may not qualify if:

• Chronic pulmonary disease
• Collagen disorders
• HIV infection if CD4 count \<200 cells/ mm3
• Chronic renal or hepatic disease
• Urinary tract infection
• Sepsis
• Body mass index (BMI) \> 50 kg/m2
• History of seizure disorder
• Intracranial haemorrhage
• History of benign or malignant intracranial neoplasia

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

Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Robert Dyer, MBChB, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Dyer, MBChB, PhD

CONTACT

+27214045001; robert.dyer@uct.ac.za

Margot Flint, PhD

CONTACT

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

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: January 10, 2023
• Study Start: November 21, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 8 months following publication of results.
• Access Criteria: Participants, clinicians and researchers.

Locations

ZA (1)