Effect of Maternal and Neonatal Oxygenation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01530971
First received: February 8, 2012
Last updated: July 1, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Peer Review, Research
Drug: Supplemental 3LPM oxygen via canula
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • proportion of maternal desaturation [ Time Frame: intraoperative period ] [ Designated as safety issue: Yes ]
    Oxygen saturation < 94% once.


Secondary Outcome Measures:
  • neonatal outcomes [ Time Frame: intraoperative period ] [ Designated as safety issue: Yes ]
    Apgar score and parameters from umbilical cord gas


Enrollment: 325
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders 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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530971

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

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

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01530971     History of Changes
Other Study ID Numbers: 10AS00008/044/10
Study First Received: February 8, 2012
Last Updated: July 1, 2013
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on October 23, 2014