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Neural Damage and Anesthetic Treatment in the Preeclamptic Parturient; a Prospective Observational Study.

NCT03551223 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-07-08

No results posted yet for this study

Summary

Objectives: Our primary objective is to evaluate the effect of anesthetic method (general versus regional anesthesia) on neural outcomes in the preeclamptic population undergoing cesarean delivery. Secondary outcome is to examine the fetal cerebral outcomes associated with the anesthetic method.

Methodology: This prospective, observational study, will include 50 preeclamptic parturients undergoing cesarean section under general and regional anesthesia.

Neuron specific enolase and S100B Protein are neuronal injury biomarkers. Increased levels of these biomarkers in serum indicate neuron damage. Following enrollment venous blood will be drawn from the participants and assessed for NSE and S100B serum levels at the following points; Upon hospital admission and one day postpartum. Furthermore in order to evaluate fetal outcomes upon fetal delivery, umbilical cord blood will be examined for NSE and S100B.

Study significance: While spinal anesthesia is the preferred anesthetic method for the preeclamptic parturient undergoing cesarean delivery, it remains uncertain which anesthetic method is neuroprotective.

This study will be the first study, to our knowledge, to examine the effect of anesthetic method on neuronal outcomes for a parturient with preeclampsia undergoing cesarean delivery, by the use of noninvasive cerebral biomarkers.

Conditions

  • Phosphopyruvate Hydratase

Interventions

BIOLOGICAL

Neuron specific enolase (NSE)

5 cc of venous blood will be drawn from all of the participants and be examined for NSE and S100 B serum levels in order to evaluate evaluate which anesthetic method (general anesthesia versus spinal anesthesia) is associated with reduced neuronal injury in a preeclamptic parturients undergoing a cesarean section.

Sponsors & Collaborators

  • Rabin Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2020-06-01
Completion
2020-06-01

Countries

  • Israel

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03551223 on ClinicalTrials.gov