Cortisol Levels in Infants Born by C-section - Electric Unipolar Needle Versus Electric Bipolar Needle
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|ClinicalTrials.gov Identifier: NCT01100970|
Recruitment Status : Unknown
Verified February 2010 by Hadassah Medical Organization.
Recruitment status was: Active, not recruiting
First Posted : April 9, 2010
Last Update Posted : February 1, 2011
|Condition or disease|
Today, on Caesarean section, there's a widely usage of electric unipolar needle for cutting tissue and / or bipolar needle to burn blood vessels. These Needles use an electric current flow for cutting the tissue. When using unipolar needle there's a transfer of the electric current through the mother's body and through the amniotic fluid , while when using bipolar needle the current goes back through the needle directly the generator so that the flow does not transfer to the amniotic fluid and fetus.
Despite the growing usage of electric needles, there is no literature information about the extent of electrical current that is transferred to the fetus during cutting, hence, no information about stress level felt by the baby as a result of electrical current exposure.
The purpose of this experiment is testing the possibility that there is a difference between cortisol levels in fetal blood of babies who were born while using a unipolar needle opposite to using a bipolar needle, and compared to the control group (infants who were born in a vaginal birth).
Also, we want to check whether there is correlation between maternal cortisol levels and newborn cortisol levels (whether motherly cortisol levels affects newborn cortisol levels).
To assess cortisol at birth, blood will be taken from the umbilical vein following clamping of the cord after birth. Saliva-based cortisol will be collected from mothers.
Other measures which will be taken are: week of birth, newborns weight, Apgar score 5 minutes after birth, mother's age and the indication for cesarean section.
Then we will compare the two experimental groups, as well as compare the two groups, to the control group, and see whether there is a statistically significant difference between the groups.
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||Cortisol Levels in Infants Born by C-section - A Comparison of Using an Electric Unipolar Needle and Electric Bipolar Needle|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||May 2011|
|Estimated Study Completion Date :||May 2011|
|Unipolar electric needle|
|Bipolar electric needle|
Infants who were born in a vaginal birth
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 ClinicalTrials.gov identifier (NCT number): NCT01100970
|Hadassah Medical Organization|
|Jerusalem, Israel, 91120|
|Principal Investigator:||David Mankuta, MD||Hadassah University Medical Organization|