Point-of-care Ultrasound Abnormalities in Eclampsia

ConditionEclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Cape Town

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Chronic pulmonary disease

Collagen disorders

HIV infection if CD4 count <200 cells/ mm3

Chronic renal or hepatic disease

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: Lung- and cardiac ultrasound, as well as optic nerve sheath diameter.Other 1 intervention

Trial outcomes

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

Time frame
35-40 minutes

Secondary outcomes

1

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

Time frame
35-40 minutes
2

The prevalence of cardiac, lung and optic nerve sheath ultrasound

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

Time frame
35-40 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cape Town

Lead sponsor

Stanford University

Collaborator