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Effect of Maternal and Neonatal Oxygenation

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ClinicalTrials.gov Identifier: NCT01530971
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Peer Review, Research Drug: Supplemental 3LPM oxygen via canula Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: room air
no supplemental oxygen in intraoperative period
Experimental: Oxygen
Supplemental 3LPM oxygen via canula
Drug: Supplemental 3LPM oxygen via canula
Parturients will receive supplemental oxygen (3LPM) via nasal canula



Primary Outcome Measures :
  1. proportion of maternal desaturation [ Time Frame: intraoperative period ]
    Oxygen saturation < 94% once.


Secondary Outcome Measures :
  1. neonatal outcomes [ Time Frame: intraoperative period ]
    Apgar score and parameters from umbilical cord gas



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01530971


Locations
Thailand
Siriraj hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Arunotai Siriussawakul, MD. Mahidol University

Additional Information:
pubmed  This link exits the ClinicalTrials.gov site

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01530971     History of Changes
Other Study ID Numbers: 10AS00008/044/10
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: June 2013

Keywords provided by Mahidol University:
oxygen
pregnancy
caesarean section
anesthetic techniques