Intrauterine ResuscitationO2P2NCT03581214
Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
A study testing No oxygen and Oxygen in people with Intrauterine Resuscitation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Resuscitation
- What is being tested?
- No oxygen and Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 910 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton
- Gestational age ≥37 weeks
- Spontaneous labor or induction of labor
- English speaking
- Ability to give informed consent
Who cannot join
- Major fetal anomaly
- Multiple gestation
- Category III electronic fetal monitoring
- Maternal hypoxia
- Preeclampsia
- Intrauterine growth restriction
- Pregestational diabetes
- Tobacco use
Trial locations and contacts
1 site in 1 country.
About this study
Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. This liberal use of O2 in laboring patients is concerning because hyperoxygenation in infants is associated with adverse outcomes including retinopathy and abnormal neurodevelopment. Furthermore, excess O2 exposure is linked to free radical generation and subsequent oxidative cell damage. This calls for a closer look at the safety of intrauterine O2 exposure. The proposed project explores potential mechanisms for harm with maternal O2 supplementation in laboring patients with Category II EFM. Specifically, this project will determine the effect of O2, compared to room air (RA), on umbilical cord and maternal levels of malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE), markers of free radical-induced oxidative stress. The study will also explore the correlation between urinary and blood markers of oxidative stress. Banked specimens will be used to investigate the potential effect of peripartum O2 exposure on placental oxidative stress in the future.
- Conditions
- Intrauterine Resuscitation
- Being tested
- No oxygen, Oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No oxygenOther
Also called Room air
No facemask, room air only
OxygenOther
10Liters/minute oxygen by facemask
| Study group | Role | What they receive |
|---|---|---|
| Room air | Active comparator | Room air (no mask) Receives: Other: No oxygen |
| Oxygen | Placebo comparator | 10L/min Oxygen by facemask Receives: Other: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Artery Malondialdehyde
Measured: At delivery
Umbilical Artery 4-hydroxynonenal
Measured: At delivery
Maternal Malondialdehyde
Measured: Within 1 hour of delivery
Maternal 4-hydroxynonenal
Measured: Within 1 hour of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start15 Jul 2018
- Primary completion17 Oct 2022
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intrauterine ResuscitationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 910 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Nandini Raghuraman, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581214
- Sponsor's protocol ID
- 201805045
- Other IDs
- 1K23HD098315-01A1
- Acronym
- O2P2
- Status last verified
- Apr 2025
- First submitted
- 26 Jun 2018
- Last updated
- 15 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
- ClinicalTrials.gov ID
- NCT03581214
- Acronym / sponsor ID
- O2P2 / 201805045
- Conditions
- Intrauterine Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 910 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Posted 15 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 2/3 of laboring women receive supplemental oxygen (O2) in an attempt to reverse perceived fetal hypoxia on electronic fetal monitoring (EFM). O2 supplementation is most commonly used in patients with Category II EFM, a class of EFM patterns designed in part to identify fetal acidemia. This liberal use of O2 in laboring patients is concerning because hyperoxygenation in infants is associated with adverse outcomes including retinopathy and abnormal neurodevelopment. Furthermore, excess O2 exposure is linked to free radical generation and subsequent oxidative cell damage. This calls for a closer look at the safety of intrauterine O2 exposure. The proposed project explores potential mechanisms for harm with maternal O2 supplementation in laboring patients with Category II EFM. Specifically, this project will determine the effect of O2, compared to room air (RA), on umbilical cord and maternal levels of malondialdehyde (MDA) and 4-hydroxynonenal (4-HNE), markers of free radical-induced oxidative stress. The study will also explore the correlation between urinary and blood markers of oxidative stress. Banked specimens will be used to investigate the potential effect of peripartum O2 exposure on placental oxidative stress in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Room air | Active comparator | Other: No oxygenRoom air (no mask) |
| Oxygen | Placebo comparator | Other: Oxygen10L/min Oxygen by facemask |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton
- Gestational age ≥37 weeks
- Spontaneous labor or induction of labor
- English speaking
- Ability to give informed consent
Key exclusion criteria (8 listed)
- Major fetal anomaly
- Multiple gestation
- Category III electronic fetal monitoring
- Maternal hypoxia
- Preeclampsia
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 |
|---|---|---|
| No oxygenAlso: Room airNo facemask, room air only | Other | Room air |
| Oxygen10Liters/minute oxygen by facemask | Other | Oxygen |
Primary outcome
Umbilical Artery Malondialdehyde
Time frame: At delivery
Umbilical Artery 4-hydroxynonenal
Time frame: At delivery
Maternal Malondialdehyde
Time frame: Within 1 hour of delivery
Maternal 4-hydroxynonenal
Time frame: Within 1 hour of delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Intrauterine Resuscitation
Recruiting
Maternal Oxygen Supplementation for Intrauterine Resuscitation
Fetal Distress, Fetal Hypoxia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No oxygen and Oxygen in people with Intrauterine Resuscitation, run by Washington University School of Medicine 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 5 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 15 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Umbilical Artery Malondialdehyde (time frame: At delivery). The study lists 4 primary outcomes in all. 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 15 Apr 2025.