Effect of Maternal and Neonatal Oxygenation

Peer Review, Research Clinical Trial

Official title: Effects of Neonate and Maternal Oxygenation in Low-dose Oxygen Supplement by Oxygen Cannula or Non- Supplement in Elective Cesarean Section: a Randomized Controlled Trial

Status Completed

Clinical Trial Summary

Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean section under spinal anesthesia. However, evidences supporting the practice is not clear nowadays, especially for healthy parturients who are monitored continuously with pulse oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and newborns.

Changing practice is not that easy. This study has been conducted to prove that supplemental oxygen is not necessary for healthy parturients during cesarean section.

Clinical Trial Description

Supplemental oxygen has been routinely given to parturients because doctors were concerned about desaturation. However, the evidences for giving oxygen was not strong, and the condition nowadays can be detected immediately with pulse oximeter which is a standard monitoring.

After this study finished, we will set a safety guideline for supplemental oxygen for healthy parturients undergoing elective cesarean section. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peer Review, Research

• NCT number: NCT01530971
• Study type: Interventional
• Source: Mahidol University
• Status: Completed
• Phase: Phase 3
• Start date: March 2012
• Completion date: March 2013