Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase

This study has been completed.
Sponsor:
Information provided by:
George Washington University
ClinicalTrials.gov Identifier:
NCT01042262
First received: December 21, 2009
Last updated: January 4, 2010
Last verified: December 2009
  Purpose

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..


Condition Intervention
Oxidative Stress
Fetal Distress
Other: Oxygen
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Diagnostic
Official Title: Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Superoxide dismutase concentration in umbilical cord blood [ Time Frame: within 4 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Superoxide dismutase concentration in maternal venous blood after delivery [ Time Frame: within 4 hours ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: February 2007
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxygen Group
Subjects received 100% oxygen via nasal cannula (flow =2 L/min)
Other: Oxygen
100% Oxygen at a flow of 2 L/min
Placebo Comparator: Control Group
Subjects were attached to a nasal cannula without any oxygen flow.
Other: Placebo
No oxygen flow

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042262

Locations
United States, District of Columbia
The George Washington University Hospital
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
  More Information

No publications provided by George Washington University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hany Aly, MD, George Washington University
ClinicalTrials.gov Identifier: NCT01042262     History of Changes
Other Study ID Numbers: 120621
Study First Received: December 21, 2009
Last Updated: January 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
Superoxide dismutase
Oxygen
Oxygen free radicals
Labor and delivery

Additional relevant MeSH terms:
Fetal Distress
Signs and Symptoms
Superoxide Dismutase
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014