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Effect of Maternal and Neonatal Oxygenation

M

Mahidol University

Status and phase

Completed
Phase 3

Conditions

Peer Review, Research

Treatments

Drug: Supplemental 3LPM oxygen via canula

Study type

Interventional

Funder types

Other

Identifiers

NCT01530971
10AS00008/044/10

Details and patient eligibility

About

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.

Full 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.

Enrollment

325 patients

Sex

Female

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

325 participants in 2 patient groups

room air
No Intervention group
Description:
no supplemental oxygen in intraoperative period
Oxygen
Experimental group
Description:
Supplemental 3LPM oxygen via canula
Treatment:
Drug: Supplemental 3LPM oxygen via canula

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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