Phosphopyruvate Hydratase Clinical Trial
Official title:
Neural Damage and Anesthetic Treatment in the Preeclamptic Parturient; a Prospective Observational Cohort Study.
NCT number | NCT03551223 |
Other study ID # | 0504-17 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | June 1, 2020 |
Verified date | June 2019 |
Source | Rabin Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: Fifty preeclamptic parturients age 18 and above presenting for cesarean delivery under SA or GA, with ability to comply with study requirements will be enrolled in the study. Exclusion Criteria: The following parturients will be excluded: 1. Parturients under age 18 2. Parturients undergoing a vaginal delivery. 3. Parturients unable to sign an informed consent forum. |
Country | Name | City | State |
---|---|---|---|
Israel | Beilinson hospital | Petach tikvah |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
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* Note: There are 24 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NSE serum levels | Maternal serum NSE levels after delivery in both study groups | 1 Day postpartum | |
Primary | S100 B protein | Maternal serum S100B levels after delivery in both study groups. Maternal serum NSE levels after delivery in both study groups | 1 Day postpartum | |
Secondary | Fetal serum NSE levels | Umbilical cord serum NSE levels | At delivery | |
Secondary | Fetal serum S100b levels | Umbilical cord serum S100b levels | At delivery |