Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase
Primary Purpose
Oxidative Stress, Fetal Distress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxygen
Placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Oxidative Stress focused on measuring Superoxide dismutase, Oxygen, Oxygen free radicals, Labor and delivery
Eligibility Criteria
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
Sites / Locations
- The George Washington University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Oxygen Group
Control Group
Arm Description
Subjects received 100% oxygen via nasal cannula (flow =2 L/min)
Subjects were attached to a nasal cannula without any oxygen flow.
Outcomes
Primary Outcome Measures
Superoxide dismutase concentration in umbilical cord blood
Secondary Outcome Measures
Superoxide dismutase concentration in maternal venous blood after delivery
Full Information
NCT ID
NCT01042262
First Posted
December 21, 2009
Last Updated
January 4, 2010
Sponsor
George Washington University
1. Study Identification
Unique Protocol Identification Number
NCT01042262
Brief Title
Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase
Official Title
Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
George Washington University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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..
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oxidative Stress, Fetal Distress
Keywords
Superoxide dismutase, Oxygen, Oxygen free radicals, Labor and delivery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen Group
Arm Type
Experimental
Arm Description
Subjects received 100% oxygen via nasal cannula (flow =2 L/min)
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Subjects were attached to a nasal cannula without any oxygen flow.
Intervention Type
Other
Intervention Name(s)
Oxygen
Intervention Description
100% Oxygen at a flow of 2 L/min
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
No oxygen flow
Primary Outcome Measure Information:
Title
Superoxide dismutase concentration in umbilical cord blood
Time Frame
within 4 hours
Secondary Outcome Measure Information:
Title
Superoxide dismutase concentration in maternal venous blood after delivery
Time Frame
within 4 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22445187
Citation
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.
Results Reference
derived
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Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase
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