AzTrials
AzTrials

Oxidative StressNCT01042262

Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase

A study testing Oxygen in people with Oxidative Stress and Fetal Distress, run by George Washington University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Oxidative Stress, Fetal Distress
What is being tested?
Oxygen
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
Feb 2007to Aug 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • uncomplicated pregnancy
  • term gestational age from completed 37 weeks to 42 weeks, and
  • normal spontaneous vaginal delivery or elective caesarean section

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The George Washington University Hospital

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase: A Randomized Controlled Trial

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..

Read the 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.

Being tested
Oxygen, Placebo
Keywords
Superoxide dismutase, Oxygen, Oxygen free radicals, Labor and delivery
Medical subject headings
Fetal Distress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxygenOther

    100% Oxygen at a flow of 2 L/min

  • PlaceboOther

    No oxygen flow

Study groups in NCT01042262
Study groupRoleWhat they receive
Oxygen GroupExperimentalSubjects received 100% oxygen via nasal cannula (flow =2 L/min)
Receives: Other: Oxygen
Control GroupPlacebo comparatorSubjects were attached to a nasal cannula without any oxygen flow.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Superoxide dismutase concentration in umbilical cord blood

    Measured: within 4 hours

Secondary outcomes (1)
  1. Superoxide dismutase concentration in maternal venous blood after delivery

    Measured: within 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2010 (estimated)
  2. Study startFeb 2007
  3. Primary completionMay 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01042262
Sponsor's protocol ID
120621
Status last verified
Dec 2009
First submitted
21 Dec 2009
Last updated
5 Jan 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22445187

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen in people with Oxidative Stress and Fetal Distress, run by George Washington University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Superoxide dismutase concentration in umbilical cord blood (time frame: within 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01042262, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2010.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in