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Evaluation of Metabolic Acid-base Abnormalities in Pre-eclamptic Women Applying the Stewart-Fencl Approach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02164370
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : October 15, 2014
University of Cape Town
Information provided by (Responsible Party):
Clemens Ortner, University of Washington

Brief Summary:
Acid/base imbalances are not well understood in pre-eclamptics, and better tools are needed to allow a thorough and meaningful evaluation. Disorders of electrolytes and albumin are common findings [13, 14], and the impact of such disorders on acid-base homeostasis has increasingly been acknowledged [4, 15]. The purpose of this prospective case-control study is to evaluate acid-base status in 100 women with mild or severe pre-eclampsia and 25 healthy controls by applying the Stewart Fencl's physicochemical acid-base model. We hypothesize that several simultaneous, and possibly offsetting, metabolic acid-base disorders will be identified and quantified, and that these may be useful to guide clinicians in their medical management and indication for delivery. Intermediate and long-term goals are to evaluate the ability of the Stewart Fencl's physicochemical acid-base model to guide fluid management and predict maternal and neonatal outcomes.

Condition or disease
Mild Pre-eclampsia Severe Pre-eclampsia

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Metabolic Acid-base Abnormalities in Pre-eclamptic Women Applying the Stewart-Fencl Approach
Study Start Date : October 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

non-pregnant controls
Acid-base in healthy non-pregnant women in childbearing age
healthy pregnant control group
healthy pregnant volunteers matched in gestational age to cases
severe pre-eclampsia
Acid-base in severe pre-eclampsia

Primary Outcome Measures :
  1. Strong Ion Difference [ Time Frame: 1 year ]
    Primary outcome measure is evaluation of strong ion difference (SID) in mild and severe pre-eclamptic women

Secondary Outcome Measures :
  1. Sequential physicochemical acid-base analysis [ Time Frame: 1 year ]
    Secondary aim is a detailed description of acid base abnormalities in mild and severe pre-eclamptic women by applying Stewart-Gilfix methodology and calculating determinants for base excess (BE).

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with mild pre-eclampsia and admitted on the labor and delivery unit at the UWMC will be included consecutively and their clinical course will be followed, until 25 cases have progressed to severe pre-eclampsia. At each state of the disease a blood gas will be drawn (mild disease, severe disease, beginning labor or with decision for cesarean delivery). However, some women will deliver before severe pre-eclampsia develops (continuing mild pre-eclampsia), because disease is either late or only slowly progressing (study flow chart).

Analyzing the number of women treated for mild and severe pre-eclampsia in 2011 and 2012, we are expecting to see a 3x higher number of mild than severe cases of pre-eclampsia, which means we will need to enroll approximately 100 women with mild pre-eclampsia in order to have 25 who develop severe pre-eclamsia..


Inclusion Criteria:

Women diagnosed with mild or severe pre-eclampsia

Exclusion Criteria:

Women in labor or presenting with chronic pulmonary disease, collagen disorders, history of lithium intoxication or history of methanol, ethanol or salicylates ingestion, urinary tract infection, chorioamnionitis, intrauterine fetal death, a body mass index (BMI) > 50 kg/m2 or acute asthma will be excluded.

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 identifier (NCT number): NCT02164370

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United States, Washington
University of Washington
Seattle, Washington, United States, 98112
South Africa
University of Cape Town
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
University of Washington
University of Cape Town
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Clemens Ortner, Assistant Professor, University of Washington Identifier: NCT02164370    
Other Study ID Numbers: 43603-A
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: October 15, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Pregnancy Complications