Oxidative Stress Clinical Trial
Official title:
Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase: A Randomized Controlled Trial
Verified date | December 2009 |
Source | George Washington University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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..
Status | Completed |
Enrollment | 60 |
Est. completion date | August 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - uncomplicated pregnancy - term gestational age from completed 37 weeks to 42 weeks, and - normal spontaneous vaginal delivery or elective caesarean section Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | The George Washington University Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
George Washington University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Superoxide dismutase concentration in umbilical cord blood | within 4 hours | Yes | |
Secondary | Superoxide dismutase concentration in maternal venous blood after delivery | within 4 hours | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
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