Cortisol Levels in Infants Born by C-section - Electric Unipolar Needle Versus Electric Bipolar Needle

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Hadassah Medical Organization.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01100970
First received: April 8, 2010
Last updated: January 30, 2011
Last verified: February 2010
  Purpose

The purpose of this study is to determine whether 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).


Condition
Delivery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cortisol Levels in Infants Born by C-section - A Comparison of Using an Electric Unipolar Needle and Electric Bipolar Needle

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples Without DNA

Bouth umbilical Blood samples and saliva samples will be kept in a -20C freezer utill assayed.


Estimated Enrollment: 90
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Unipolar electric needle
Bipolar electric needle
Control
Infants who were born in a vaginal birth

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

pregnant women who needs c-section.

Criteria

Inclusion Criteria:

  1. Healthy women, without significant background and/or chronic diseases.
  2. Women who did not experienced illnesses that may pass to the fetus during pregnancy, or any other medical complication related to pregnancy.
  3. All indications for C-section are medical indications.
  4. Male newborn, week 37-42 of pregnant.
  5. Without any evidence of stress event suffered by the mother or fetus during pregnancy or at birth.

Exclusion Criteria:

  1. Women over 45 years of age, or under the age of 20.
  2. Women with significant background and/or chronic diseases.
  3. Women who experienced medical complications during pregnancy.
  4. C-section indication are urgent due to mother/fetus distress.
  5. Female newborn, or a male newborn who wasn't born during week37-42 of pregnancy.
  6. Evidence of a stress event suffered by the mother and/or fetus during pregnancy or at birth.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100970

Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: David Mankuta, MD Hadassah University Medical Organization
  More Information

Publications:
Responsible Party: David Mankuta, MD, Hadassah Ein-Kerem - obstetrics and gynecology
ClinicalTrials.gov Identifier: NCT01100970     History of Changes
Other Study ID Numbers: 0008-10HMO-CTIL
Study First Received: April 8, 2010
Last Updated: January 30, 2011
Health Authority: Israel: Ethics Commission

Keywords provided by Hadassah Medical Organization:
Caesarean section
cortisol
stress
unipolar electric needle
bipolar electric needle

Additional relevant MeSH terms:
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents

ClinicalTrials.gov processed this record on August 19, 2014