跳至主要内容
临床试验/NCT01100970
NCT01100970Unknown不适用

Cortisol Levels in Infants Born by C-section - A Comparison of Using an Electric Unipolar Needle and Electric Bipolar Needle

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Women over 45 years of age, or under the age of
  • 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.

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验