NCT01530971

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

July 2, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

February 8, 2012

Last Update Submit

July 1, 2013

Conditions

Peer Review, Research

Keywords

oxygenpregnancycaesarean sectionanesthetic techniques

Outcome Measures

Primary Outcomes (1)

  • proportion of maternal desaturation

    Oxygen saturation \< 94% once.

    intraoperative period

Secondary Outcomes (1)

  • neonatal outcomes

    intraoperative period

Study Arms (2)

room air

NO INTERVENTION

no supplemental oxygen in intraoperative period

Oxygen

EXPERIMENTAL

Supplemental 3LPM oxygen via canula

Drug: Supplemental 3LPM oxygen via canula

Interventions

Supplemental 3LPM oxygen via canulaDRUG

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

Oxygen

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged \> 18 years old.
  • Term pregnancy (gestational age 37 -42 weeks).
  • Singleton
  • Elective cesarean section.

You may not qualify if:

  • History of infertility
  • Diabetes
  • Hypertension or preeclampsia
  • Heart disease
  • Morbid obesity
  • Premature rupture of membrane
  • Placenta previa
  • Preoperative oxygen saturation \< 95%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

Location

Related Links

Study Officials

  • Arunotai Siriussawakul, MD.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 10, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

July 2, 2013

Record last verified: 2013-06

Locations

TH(1)