Effect of Maternal and Neonatal Oxygenation

Peer Review, Research Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01530971
• Other study ID #: 10AS00008/044/10
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2012
• Last updated: July 1, 2013
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: June 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peer Review, Research

Intervention

Drug:
• Supplemental 3LPM oxygen via canula
Parturients will receive supplemental oxygen (3LPM) via nasal canula

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of maternal desaturation	Oxygen saturation < 94% once.	intraoperative period	Yes
Secondary	neonatal outcomes	Apgar score and parameters from umbilical cord gas	intraoperative period	Yes

External Links

•   british journal of anesthesia
•   Mahidol library
•   pubmed