Effect of Maternal and Neonatal Oxygenation
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|ClinicalTrials.gov Identifier: NCT01530971|
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : July 2, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Peer Review, Research||Drug: Supplemental 3LPM oxygen via canula||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||325 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530971
|Bangkok, Thailand, 10700|
|Principal Investigator:||Arunotai Siriussawakul, MD.||Mahidol University|