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OpenTrials
Completed

NCT Number: NCT01530971

Effect of Maternal and Neonatal Oxygenation

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.

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Key information

Conditions

Peer Review, Research

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Siriraj hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Supplemental 3LPM oxygen via canula

Drug

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

Primary outcomes

  1. proportion of maternal desaturation

    Time frame: intraoperative period

    Oxygen saturation < 94% once.

Secondary outcomes

  1. neonatal outcomes

    Time frame: intraoperative period

    Apgar score and parameters from umbilical cord gas

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 10, 2012
Registry last updated
Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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