Effect of Maternal and Neonatal Oxygenation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- proportion of maternal desaturation [ Time Frame: intraoperative period ] [ Designated as safety issue: Yes ]Oxygen saturation < 94% once.
- neonatal outcomes [ Time Frame: intraoperative period ] [ Designated as safety issue: Yes ]Apgar score and parameters from umbilical cord gas
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
No Intervention: room air
no supplemental oxygen in intraoperative period
Drug: room air
parturients will not receive supplemental oxygen.
Other Name: room air
supplemental oxygen with oxygen canula 3LPM in intraoperative period.
supplemental oxygen 3LPM in intraoperative period
Other Name: oxygen canula
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.
|Contact: Aungsumat Wangdee, RNemail@example.com|
|Siriraj hospital||Not yet recruiting|
|Bangkok, Thailand, 10700|
|Principal Investigator: Arunotai Siriussawakul, MD.|
|Principal Investigator:||Arunotai Siriussawakul, MD.||Mahidol University|