Clinical Trials Logo

Clinical Trial 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..


Clinical Trial Description

We conducted a prospective randomized controlled clinical trial on a cohort of delivering women who were admitted to the Childbirth center at the George Washington University Hospital. This study has been approved by the Institutional Review Board of the George Washington University and consents were obtained from all subjects before enrollment. All of the enrolled subjects met the following criteria: a) uncomplicated pregnancy, b) term gestational age from completed 37 weeks to 42 weeks, and c) normal spontaneous vaginal delivery (NSVD) or elective caesarean section. Pregnant women were excluded from this study if they had any of the following: a) hypertension, or eclampsia, b) pregnancy induced diabetes, c) anemia, d) other medical or surgical complications during the current pregnancy, e) rupture of amniotic membranes for more than 18 hours, f) history of infants with invasive group B Streptococcal disease in previous pregnancies, g) fetal distress before delivery and h) suspected chromosomal, and structural anomalies or congenital infections. We collected data on maternal history (age, race, parity and type of anesthesia) and birth history (anthropometric measurements, gestational age, sex, and Apgar scores).

Randomization: Once enrolled in the study, all of the subjects were randomly assigned to one of two groups using the sealed opaque envelopes technique. A nasal cannula was attached to all subjects and was connected to a flowmeter covered by a metal foil so that the managing obstetricians were not aware which group the particular subject belongs to. The Oxygen Group participants received 100% oxygen at 2 litters/minute starting at least 30 minutes before delivery. The Control Group participants had their nasal cannula still attached to a flowmeter that was turned off. Nasal cannula was disconnected from participants after delivery.

Monitoring procedure: Pregnant women were monitored continuously for heart rate, respiratory rate and oxygen saturation. If oxygen saturation decreased < 93% for at least 60 seconds, and/or when considered necessary by the obstetrician at any time, therapeutic oxygen was administered and the participant was excluded from the study.

Laboratory investigation: We obtained three samples of three mls of whole blood from each mother-infant pair in both groups. The first blood sample was obtained from the participants' peripheral vein at the time of enrollment before randomization (Baseline). The second blood sample was obtained from the placental side of umbilical cord after delivery. The third sample was obtained from the partcipants' peripheral vein within 4 hours after delivery.

We measured blood gases in each sample at the bedside using an iSTAT analyzer (Abbott, IL). The rest of the sample was used for SOD assays. It was collected in an iced-tube containing EDTA, and centrifuged at 4 ºC. Plasma was discarded and the erythrocyte suspension was washed with normal saline and centrifuged again twice. Washed erythrocyte suspensions were stored at -70 ºC until the time of assay.

SOD concentration was measured by an indirect colorimetric method using the highly water-soluble tetrazolium salt WST-1, which produces a water-soluble formazan dye upon reduction with a superoxide anion. The Cayman Chemical SOD assay kit was used for the measurement of SOD activity in erythrocyte lysate. SOD activity was assessed by measuring the dismutation of superoxide radicals generated by xanthine oxidize and hypoxanthine in a convenient 96 well format. This technique included a quality-controlled SOD standard. The standard curve, which was generated using this enzyme, provides a means to accurately quantify the activity of all three types of SOD (Cu/Zn-, Mn-, and Fe-SOD). SOD concentration expressed in IU per gram of hemoglobin content. Results of SOD concentration, pH, pCO2, pO2, base deficit, Ht and Na concentration were recorded. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT01042262
Study type Interventional
Source George Washington University
Contact
Status Completed
Phase N/A
Start date February 2007
Completion date August 2009

See also
  Status Clinical Trial Phase
Completed NCT03255187 - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution N/A
Completed NCT04136821 - The Long-term Effects of Oceanix™ on Resistance Training Adaptations N/A
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Completed NCT03358524 - Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia Phase 4
Recruiting NCT05327348 - Effectiveness of IV Vitamin C in Reducing Oxidative Stress Associated With Free Flap Surgery Phase 3
Completed NCT03288623 - The Effects of Dark Chocolate Implementation in Elite Athletes N/A
Completed NCT04419025 - Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease Phase 2
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Not yet recruiting NCT06159543 - The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes N/A
Enrolling by invitation NCT03030456 - Whole Body Vibrations on Functional Capacity, Muscular Strength, and Biochemical Profile in Elders N/A
Not yet recruiting NCT02202239 - Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients Phase 4
Completed NCT02256254 - SIMOX - Induction of Oxidative Stress Phase 2
Recruiting NCT02048592 - Impact of Immunonutrition on the Patients With Cystic Fibrosis Phase 4
Completed NCT01942460 - Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients Phase 4
Completed NCT02463318 - The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects N/A
Completed NCT01990391 - Brazil Nut Consumption in Microvascular Endothelial Function, Oxidative Stress and Metabolic Abnormalities N/A
Completed NCT02177383 - Action of Essential Fatty Acids on the Expression of Antioxidant Genes and Athletic Performance N/A
Completed NCT00845130 - Quantitative in Vivo Biomarkers of Oxidative Stress in Diabetes N/A
Completed NCT00607893 - Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea N/A
Active, not recruiting NCT00247507 - The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients Phase 4