Effect of Maternal and Neonatal Oxygenation

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01530971

Enrollment

325

Registered

2012-02-10

Start date

2012-03-31

Completion date

2013-03-31

Last updated

2013-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peer Review, Research

Keywords

oxygen, pregnancy, caesarean section, anesthetic techniques

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.

Interventions

DRUGSupplemental 3LPM oxygen via canula

Parturients will receive supplemental oxygen (3LPM) via nasal canula

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to No maximum

Healthy volunteers

Yes

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%

Design outcomes

Primary

Measure	Time frame	Description
proportion of maternal desaturation	intraoperative period	Oxygen saturation \< 94% once.

Secondary

Measure	Time frame	Description
neonatal outcomes	intraoperative period	Apgar score and parameters from umbilical cord gas

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026