Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase
1 other identifier
interventional
60
1 country
1
Brief Summary
When exposed to oxygen immediately after birth, newborns suffer from an oxidative stress with a significant decrease in serum concentration of the anti-oxidant enzyme superoxide dismutase. This oxidative stress has been consequently linked to the development of adverse outcomes in both premature and full term infants. In this study, we examined the effect of oxygen administration to delivering mothers immediately before and during labor on the newborn. In this randomized trial, we planned to measure superoxide dismutase in the umbilical cord blood when mothers received and did not receive oxygen..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2007
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 21, 2009
CompletedFirst Posted
Study publicly available on registry
January 5, 2010
CompletedJanuary 5, 2010
December 1, 2009
2.2 years
December 21, 2009
January 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Superoxide dismutase concentration in umbilical cord blood
within 4 hours
Secondary Outcomes (1)
Superoxide dismutase concentration in maternal venous blood after delivery
within 4 hours
Study Arms (2)
Oxygen Group
EXPERIMENTALSubjects received 100% oxygen via nasal cannula (flow =2 L/min)
Control Group
PLACEBO COMPARATORSubjects were attached to a nasal cannula without any oxygen flow.
Interventions
Eligibility Criteria
You may qualify if:
- uncomplicated pregnancy
- term gestational age from completed 37 weeks to 42 weeks, and
- normal spontaneous vaginal delivery or elective caesarean section
You may not qualify if:
- hypertension, or eclampsia
- diabetes
- anemia
- other medical or surgical complications during the current pregnancy
- rupture of amniotic membranes for more than 18 hours
- history of infants with invasive group B Streptococcal disease in previous pregnancies
- fetal distress before delivery, and
- suspected chromosomal, and structural anomalies or congenital infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
Related Publications (1)
Nesterenko TH, Acun C, Mohamed MA, Mohamed AN, Karcher D, Larsen J Jr, Aly H. Is it a safe practice to administer oxygen during uncomplicated delivery: a randomized controlled trial? Early Hum Dev. 2012 Aug;88(8):677-81. doi: 10.1016/j.earlhumdev.2012.02.007. Epub 2012 Mar 23.
PMID: 22445187DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2009
First Posted
January 5, 2010
Study Start
February 1, 2007
Primary Completion
May 1, 2009
Study Completion
August 1, 2009
Last Updated
January 5, 2010
Record last verified: 2009-12