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Trial record 8 of 120 for:    severe preeclampsia AND delivery

Acid-Base and Point of Care Ultrasound in Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT02721771
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : April 26, 2017
Sponsor:
Collaborators:
Medical University of Vienna
University of Washington
Information provided by (Responsible Party):
Robert Dyer, University of Cape Town

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.


Condition or disease Intervention/treatment
Pre-Eclampsia Procedure: Ultrasound examination

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 97 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acid-base Disturbances and Ultrasound Markers as Biological Predictors of Maternal and Fetal Outcomes in Severe Late Onset Preeclampsia
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Procedure: Ultrasound examination
    echocardiographic diastology and bilateral B-line pattern will be assessed. Optic nerve sheath diameter will be assessed.
    Other Name: ONSD, B-pattern, diastology


Primary Outcome Measures :
  1. Association BE(alb) and with delivery outcome [ Time Frame: 24hours ]
    Comparison number of patients with abnormal BE(alb) with number of patients undergoing emergency cesarean section (indicated through abnormal CTG).

  2. Correlation BE(alb) with comet score and optic nerve sheath diameter (ONSD) [ Time Frame: 24hrs ]
    correlation BE(alb) with comet score and optic nerve sheath diameter (ONSD)


Secondary Outcome Measures :
  1. Association B-pattern on lung ultrasound and delivery outcome [ Time Frame: 24hrs ]
    Comparison number of patients with B-pattern on lung ultrasound with number of patients undergoing emergency cesarean section (indicated through abnormal CTG).

  2. Association increased intracranial pressure (ICP) based on ONSD and delivery outcome [ Time Frame: 24hrs ]
    Comparison number of patients with increased ICP (=ONSD>5.8mm) with number of patients undergoing emergency cesarean section (indicated through abnormal CTG).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721771


Locations
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South Africa
University of Cape Town
Cape Town, Western Cape/Observatory, South Africa, 7925
Sponsors and Collaborators
University of Cape Town
Medical University of Vienna
University of Washington
Investigators
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Principal Investigator: Robert A Dyer, MD University of Cape Town

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Responsible Party: Robert Dyer, Professor Robert Anthony Dyer, University of Cape Town
ClinicalTrials.gov Identifier: NCT02721771     History of Changes
Other Study ID Numbers: UCapeTown
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Pre-Eclampsia
Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications