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

NCT02164370 | Completed

• 1 other identifier: 43603-A
• Study Type: observational
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Mild Pre-eclampsia; Severe Pre-eclampsia

Outcome Measures

Primary Outcomes (1)

• Strong Ion Difference

  Primary outcome measure is evaluation of strong ion difference (SID) in mild and severe pre-eclamptic women

  1 year

Secondary Outcomes (1)

• Sequential physicochemical acid-base analysis

  1 year

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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..

You may qualify if:

• Women diagnosed with mild or severe pre-eclampsia

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

University of Washington

Seattle, Washington, 98112, United States

Location

University of Cape Town

Cape Town, Western Cape, South Africa

Location

Related Publications (1)

• 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.

  PMID: 26170350 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

VBGs

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: June 16, 2014
• Study Start: October 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

US (1); ZA (1)