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.
|Peer Review, Research||Drug: Supplemental 3LPM oxygen via canula||Phase 3|
|Study Design:||Allocation: Randomized
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 ]Oxygen saturation < 94% once.
- neonatal outcomes [ Time Frame: intraoperative period ]Apgar score and parameters from umbilical cord gas
|Study Start Date:||March 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
No Intervention: room air
no supplemental oxygen in intraoperative period
Supplemental 3LPM oxygen via canula
Drug: Supplemental 3LPM oxygen via canula
Parturients will receive supplemental oxygen (3LPM) via nasal 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01530971
|Bangkok, Thailand, 10700|
|Principal Investigator:||Arunotai Siriussawakul, MD.||Mahidol University|