Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase

NCT ID: NCT01042262

Last Updated: 2010-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-08-31

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.

Conditions

Oxidative Stress; Fetal Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Oxygen Group

Subjects received 100% oxygen via nasal cannula (flow =2 L/min)

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: OTHER

100% Oxygen at a flow of 2 L/min

Control Group

Subjects were attached to a nasal cannula without any oxygen flow.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

No oxygen flow

Interventions

Oxygen

100% Oxygen at a flow of 2 L/min

Intervention Type: OTHER

Placebo

No oxygen flow

Intervention Type: OTHER

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

George Washington University

Locations

The George Washington University Hospital

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22445187 (View on PubMed)

Other Identifiers

120621

Identifier Type: -

Identifier Source: org_study_id