Acid-Base and Point of Care Ultrasound in Severe Preeclampsia

NCT02721771 | Completed

• 1 other identifier: UCapeTown
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia remains a leading cause of maternal morbidity and mortality, in both the developed and developing world. 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 800 women in 2014, who were classified as having preeclampsia with severe features. Given the complexity of the disease, anesthetic management for Caesarean section in these patients remains very challenging. Recent studies have begun to demonstrate novel markers of preeclampsia severity, including point-of-care ultrasound (POC-US) and acid-base (AB) abnormalities. For example, pilot studies have demonstrated that approximately 25% of women diagnosed with severe preeclampsia show signs of increased intracranial pressure and elevated lung water as evaluated by point of care ultrasound. These findings could serve as noninvasive markers of disease severity, and thus may be used to predict maternal and fetal outcome in preeclamptic women. Point of care ultrasound is playing an increasing role in perioperative diagnosis, and newer, less expensive devices are continuously being developed, and 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 severe preeclamptic women demonstrated significant abnormalities in independent acid-base determinants. In addition, strong indications were found that changes in acid-base status in preeclampsia are more pronounced earlier in pregnancy and are associated with urgent deliveries. As in other clinical arenas in critically ill patients, acid-base abnormalities are associated with increased lung water, increased intracranial pressure, and outcome, and we hypothesize that similar associations might be found in severe preeclamptic women. Therefore, one aim of this study is to evaluate the association of venous acid base abnormalities (an inexpensive and readily available test) observed in late onset severe preeclampsia and organ manifestations identified with ultrasound, a well-validated and robust tool for identifying these manifestations. Investigators will further examine the association between ultrasound findings and/or venous acid-base abnormalities with urgent delivery. It is intended to do a subsequent comparison between early- and late onset preeclampsia, when a suitable tertiary site has been identified.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (2)

• Association BE(alb) and with delivery outcome

  Comparison number of patients with abnormal BE(alb) with number of patients undergoing emergency cesarean section (indicated through abnormal CTG).

  24hours

• Correlation BE(alb) with comet score and optic nerve sheath diameter (ONSD)

  correlation BE(alb) with comet score and optic nerve sheath diameter (ONSD)

  24hrs

Secondary Outcomes (2)

• Association B-pattern on lung ultrasound and delivery outcome

  24hrs

• Association increased intracranial pressure (ICP) based on ONSD and delivery outcome

  24hrs

Interventions

Ultrasound examination PROCEDURE

echocardiographic diastology and bilateral B-line pattern will be assessed. Optic nerve sheath diameter will be assessed.

Also known as: ONSD, B-pattern, diastology

Eligibility Criteria

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

Study Population

Women diagnosed with late onset severe preeclampsia according to the definition of the Royal college of obstetricians and gynaecologists.

You may qualify if:

• age \> 18years
• previously healthy
• new late onset severe preeclampsia

You may not qualify if:

• labour
• chronic obstructive pulmonary disease (COPD)
• collagen disorder
• ho lithium intoxication
• ho of methanol, ethanol, salicylates ingestion
• HIV
• regular ingestion of antacids
• chronic renal disease
• chronic hepatic disease
• urinary tract infection (UTI),
• infection, sepsis
• BMI\>50
• acute asthma
• unable to provide consent

Sponsors & Collaborators

• University of Cape Town: lead
• Medical University of Vienna: collaborator
• University of Washington: collaborator

Study Sites (1)

University of Cape Town

Cape Town, Western Cape/Observatory, 7925, South Africa

Location

Related Publications (1)

• Ortner CM, Krishnamoorthy V, Neethling E, Flint M, Swanevelder JL, Lombard C, Fawcus S, Dyer RA. Point-of-Care Ultrasound Abnormalities in Late-Onset Severe Preeclampsia: Prevalence and Association With Serum Albumin and Brain Natriuretic Peptide. Anesth Analg. 2019 Jun;128(6):1208-1216. doi: 10.1213/ANE.0000000000003759.

  PMID: 31094790 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert A Dyer, MD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Robert Anthony Dyer

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: March 29, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

ZA (1)