Obstetrical Complication of AnesthesiaNCT02804555
Effects of Intraoperative Oxygen Therapy on Oxygenation of Newborns Born Via Elective Cesarian Section
A study testing Oxygen in people with Obstetrical Complication of Anesthesia, run by Szeged University at 1 site in Hungary.
Trial summary
In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstetrical Complication of Anesthesia
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteHungary
- Study dates
- Jun 2013to 30 Nov 2016
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elective cesarean section.
- Signed informed consent form.
Who cannot join
- Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád megye, 6725
About this study
Official title: Effects of Intraoperative Oxygen Therapy on Oxygenation and Reactive Oxygen Species Levels of Newborns Born Via Elective Cesarian Section
In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial artery in parallel with umbilical clamping and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a properly equipped laboratory.
Read the detailed description
Whole-blood superoxide and hydrogen peroxide production was measured from the newborn's umbilical chord.
- Conditions
- Obstetrical Complication of Anesthesia
- Being tested
- Oxygen
- Keywords
- reactive oxygen species, elective cesarean section, oxygen therapy, newborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenOther
Oxygen administration
| Study group | Role | What they receive |
|---|---|---|
| Oxygen support | Active comparator | 5 liter / minute oxygen has given to the mothers on face mask. Receives: Other: Oxygen |
| Room air | No intervention | Oxygen support has not given to the mothers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperoxia Newborns
We measured umbilical vein blood gas parameters.
Measured: through study completion up to two years
Secondary outcomes (2)
Maternal hyperoxia
We measured arterial blood gas parameters of the mother from radial artery.
Measured: through study completion up to two years
Alterations in newborns' enzyme functions due to maternal hyperoxia
We measured umbilical vein reactive oxygen species (ROS) of the newborn.
Measured: through study completion up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2013
- Primary completionJun 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetrical Complication of AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Domonkos Trásy, Szeged University
- Investigators
- Zsolt Molnar, MD, Principal investigator, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804555
- Sponsor's protocol ID
- Maternal hyperoxia
- Status last verified
- Nov 2016
- First submitted
- 6 Jun 2016
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Oxygen Therapy on Oxygenation and Reactive Oxygen Species Levels of Newborns Born Via Elective Cesarian Section
- ClinicalTrials.gov ID
- NCT02804555
- Acronym / sponsor ID
- Maternal hyperoxia
- Conditions
- Obstetrical Complication of Anesthesia
- Keywords
- reactive oxygen species, elective cesarean section, oxygen therapy, newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators examine the effects of intraoperative oxygen administration to the mother on certain enzyme functions of the newborn. With this object blood samples are taken from the newborn's umbilical chord - which is otherwise a routine practice at the investigators clinic - and the mother's radial artery in parallel with umbilical clamping and cutting for blood gas and reactive oxygen species analyses. Samples are analyzed locally in a properly equipped laboratory.
Detailed description
Whole-blood superoxide and hydrogen peroxide production was measured from the newborn's umbilical chord.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen support | Active comparator | Other: Oxygen5 liter / minute oxygen has given to the mothers on face mask. |
| Room air | No intervention | –Oxygen support has not given to the mothers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Elective cesarean section.
- Signed informed consent form.
Key exclusion criteria (1 listed)
- Subject meets the definition of a vulnerable subject as defined in International Organization for Standardization 14155:2011.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenOxygen administration | Other | Oxygen support |
Primary outcome
Hyperoxia Newborns
Time frame: through study completion up to two years
We measured umbilical vein blood gas parameters.
2 secondary outcomes
Maternal hyperoxia
Time frame: through study completion up to two years
Alterations in newborns' enzyme functions due to maternal hyperoxia
Time frame: through study completion up to two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Obstetrical Complication of Anesthesia
Active, not recruitingPhase 2/3
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Depression, Postpartum, Analgesia, Obstetrical
RecruitingObservational study
Non-invasive Detection of Iron Deficiency in Obstetrics
Iron Deficiency Anemia of Pregnancy, Iron-deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zsolt Molnar, MD principal investigator
Szeged University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with Obstetrical Complication of Anesthesia, run by Szeged University at 1 site in Hungary.
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 2 inclusion and 1 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 27 Apr 2017. 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 Hungary. 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. 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?
Hyperoxia Newborns (time frame: through study completion up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2017.