NCT02164370|Completed
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Sponsor study identifier
observational
120
2 countries
2
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2014
Actual (reported)Study Completion
October 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 7, 2013
Actual (reported)April 2014
Actual (reported)June 16, 2014
Actual (reported)October 2014
Actual (reported)Strong Ion Difference
Primary outcome measure is evaluation of strong ion difference (SID) in mild and severe pre-eclamptic women
1 year
Sequential physicochemical acid-base analysis
1 year
Acid-base in healthy non-pregnant women in childbearing age
healthy pregnant volunteers matched in gestational age to cases
Acid-base in severe pre-eclampsia
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..
University of Washington
Seattle, Washington, 98112, United States
University of Cape Town
Cape Town, Western Cape, South Africa
Ortner CM, Combrinck B, Allie S, Story D, Landau R, Cain K, Dyer RA. Strong ion and weak acid analysis in severe preeclampsia: potential clinical significance. Br J Anaesth. 2015 Aug;115(2):275-84. doi: 10.1093/bja/aev221.
VBGs
120 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2013
First Posted
June 16, 2014
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy and Safety of 1 g Vs 2 g Per Hour Intravenous Maintenance Dose of MgSO4 in Women With Severe Pre-eclampsia
Contact the study team to confirm eligibility.
Primary Completion
April 2014
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
October 15, 2014
Record last verified: 2014-10
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