Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05678062

Point-of-care Ultrasound Abnormalities in Eclampsia

Led by University of Cape Town · Updated on 2024-07-17

70

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

Sponsors

U

University of Cape Town

Lead Sponsor

S

Stanford University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Point-of-care Ultrasound Abnormalities in Eclampsia

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of preeclampsia following ACOG definition with new onset of tonic-clonic seizures.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Groote Schuur Hospital

Cape Town, Western Cape, South Africa, 7599

Actively Recruiting

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Research Team

R

Robert Dyer, MBChB, PhD

CONTACT

M

Margot Flint, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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