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

NCT01100970 | Unknown

• 1 other identifier: 0008-10HMO-CTIL
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Delivery

Keywords

Caesarean section; cortisol; stress; unipolar electric needle; bipolar electric needle

Study Arms (3)

Unipolar electric needle

Bipolar electric needle

Control

Infants who were born in a vaginal birth

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

pregnant women who needs c-section.

You may qualify if:

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

You may not qualify if:

• Women over 45 years of age, or under the age of 20.
• Women with significant background and/or chronic diseases.
• Women who experienced medical complications during pregnancy.
• C-section indication are urgent due to mother/fetus distress.
• Female newborn, or a male newborn who wasn't born during week37-42 of pregnancy.
• Evidence of a stress event suffered by the mother and/or fetus during pregnancy or at birth.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Related Publications (1)

• Gitau R, Menson E, Pickles V, Fisk NM, Glover V, MacLachlan N. Umbilical cortisol levels as an indicator of the fetal stress response to assisted vaginal delivery. Eur J Obstet Gynecol Reprod Biol. 2001 Sep;98(1):14-7. doi: 10.1016/s0301-2115(01)00298-6.

  PMID: 11516793 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

Study Officials

• David Mankuta, MD

  Hadassah University Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2010
• First Posted: April 9, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 1, 2011

Record last verified: 2010-02

Locations

IL (1)