Effect of Maternal and Neonatal Oxygenation

Phase 3

Completed

• Conditions: Peer Review, Research
• Interventions: Drug: Supplemental 3LPM oxygen via canula

• Registration Number: NCT01530971
• Lead Sponsor: Mahidol University

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2012-02-08
• Study First Submitted QC: 2012-02-09
• Study First Posted: 2012-02-10
• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-06
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 325

Inclusion Criteria

• Aged > 18 years old.
• Term pregnancy (gestational age 37 -42 weeks).
• Singleton
• Elective cesarean section.

Exclusion Criteria

• History of infertility
• Diabetes
• Hypertension or preeclampsia
• Heart disease
• Morbid obesity
• Premature rupture of membrane
• Placenta previa
• Preoperative oxygen saturation < 95%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen	Supplemental 3LPM oxygen via canula	Supplemental 3LPM oxygen via canula

Primary Outcome Measures

Name	Time	Method
proportion of maternal desaturation	intraoperative period	Oxygen saturation \< 94% once.

Secondary Outcome Measures

Name	Time	Method
neonatal outcomes	intraoperative period	Apgar score and parameters from umbilical cord gas

Trial Locations

Locations (1)

Siriraj hospital; 🇹🇭 Bangkok, Thailand