Effect of Maternal and Neonatal Oxygenation

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Peer Review, Research

Intervention / Treatment
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* Drug: Supplemental 3LPM oxygen via canula


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: room air<br>no supplemental oxygen in intraoperative period | |
| Experimental: Oxygen<br>Supplemental 3LPM oxygen via canula | Drug: Supplemental 3LPM oxygen via canula<br>* Parturients will receive supplemental oxygen (3LPM) via nasal canula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of maternal desaturation | Oxygen saturation < 94% once. | intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal outcomes | Apgar score and parameters from umbilical cord gas | intraoperative period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxygen, pregnancy, caesarean section, anesthetic techniques