Fetal DistressMOXYNCT05681624
Maternal Oxygen Supplementation for Intrauterine Resuscitation
A study testing Maternal oxygen supplementation and Room air in people with Fetal Distress and Fetal Hypoxia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Distress, Fetal Hypoxia, Labor and Delivery Complication
- What is being tested?
- Maternal oxygen supplementation and Room air
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,252 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Singleton gestation
- Gestational age>=37 weeks
- Spontaneous labor or induction of labor
- English or spanish speaking
- Planned continuous fetal monitoring
Who cannot join
- Preterm gestation
- Major fetal anomaly
- Multiple gestation
- Category III fetal monitoring at time of admission
- Maternal hypoxia <95%
- Planned or scheduled cesarean delivery Excluded from randomization if receiving nitrous oxide for analgesia at time of randomization.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Barnes Jewish Hospital
St Louis, Missouri, 63110
Nandini Raghuraman, MD MS
About this study
Official title: Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial
More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor \& Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor \& Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.
- Being tested
- Maternal oxygen supplementation, Room air
- Medical subject headings
- Fetal Distress, Fetal Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal oxygen supplementationOther
Maternal oxygen supplementation 10 liters/minute via nonrebreather mask
Room airOther
Room air, no mask
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Other | Not described Receives: Other: Maternal oxygen supplementation |
| Room air | Active comparator | Not described Receives: Other: Room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of neonates meeting criteria for composite neonatal morbidity
One of the following diagnoses: Neonatal death, acidemia, meconium aspiration with pulmonary hypertension, hypoglycemia, hypoxic ischemic encephalopathy ,hypothermia treatment, seizure, respiratory distress
Measured: Up to 28 days of life
Secondary outcomes (17)
Perentage of patients with operative delivery (cesarean or operative vaginal delivery)
Measured: At delivery
Percentage of patients with operative delivery for the indication of nonreassuring fetal status
Measured: At delivery
Percentage of neonates with neonatal death
Measured: 28 days of life
Percentage of neonates with acidemia (pH<7.1)
On delivery cord gas
Measured: At time of delivery
Percentage of neonates with meconium aspiration with pulmonary hypertension
Measured: Within 72 hours of delivery
Percentage of neonates with hypoglycemia
Measured: Within 24 hours of delivery
Percentage of neonates with hypoxic ischemic encephalopathy
Measured: Within 72 hours of delivery
Percentage of neonates with hypothermia treatment
Measured: Within 72 hours of delivery
Percentage of neonates with seizure
Measured: 28 days of life
Percentage of neonates with respiratory distress
Measured: Within 72 hours of delivery
umbilical artery base excess
Measured: At delivery
umbilical artery partial pressure oxygen
Measured: At delivery
umbilical artery partial pressure carbon dioxide
Measured: At delivery
Percentage of patients with composite maternal morbidity
any diagnosis of the following: postpartum hemorrhage [estimated blood loss >1000 mL]; severe perineal laceration, endometritis
Measured: Within 2 weeks of delivery
Apgars at 5 and 10 minutes
Measured: At 5 and 10 minutes of neonatal life
Apgar<5 at 5 and 10 mins
Measured: At 5 and 10 minutes of neonatal life
Percentage of neonates with Neonatal Intensive care unit admission
Measured: Within 72 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start22 May 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DistressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,252 participants (estimated)
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), University of Michigan, University of Texas at Austin, Women and Infants Hospital of Rhode Island, Dell Children's Medical Center of Central Texas, Brown University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681624
- Sponsor's protocol ID
- 202209042
- Other IDs
- R01HD108614
- Acronym
- MOXY
- Status last verified
- Aug 2026
- First submitted
- 14 Dec 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will plan to share de-identified participant data and outcomes, study protocol, and analytic code via the NICHD Data and Specimen Hub (DASH).
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT05681624
- Acronym / sponsor ID
- MOXY / 202209042
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,252 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Michigan, University of Texas at Austin, Women and Infants Hospital of Rhode Island, Dell Children's Medical Center of Central Texas, Brown University
- Study start
- 22 May 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jan 2023 (actual)
- 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.
More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor \& Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor \& Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Other | Other: Maternal oxygen supplementation |
| Room air | Active comparator | Other: Room air |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Singleton gestation
- Gestational age>=37 weeks
- Spontaneous labor or induction of labor
- English or spanish speaking
- Planned continuous fetal monitoring
Key exclusion criteria (6 listed)
- Preterm gestation
- Major fetal anomaly
- Multiple gestation
- Category III fetal monitoring at time of admission
- Maternal hypoxia <95%
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 |
|---|---|---|
| Maternal oxygen supplementationMaternal oxygen supplementation 10 liters/minute via nonrebreather mask | Other | Oxygen |
| Room airRoom air, no mask | Other | Room air |
Primary outcome
Percentage of neonates meeting criteria for composite neonatal morbidity
Time frame: Up to 28 days of life
One of the following diagnoses: Neonatal death, acidemia, meconium aspiration with pulmonary hypertension, hypoglycemia, hypoxic ischemic encephalopathy ,hypothermia treatment, seizure, respiratory distress
17 secondary outcomes
Perentage of patients with operative delivery (cesarean or operative vaginal delivery)
Time frame: At delivery
Percentage of patients with operative delivery for the indication of nonreassuring fetal status
Time frame: At delivery
Percentage of neonates with neonatal death
Time frame: 28 days of life
Percentage of neonates with acidemia (pH<7.1)
Time frame: At time of delivery
Percentage of neonates with meconium aspiration with pulmonary hypertension
Time frame: Within 72 hours of delivery
Percentage of neonates with hypoglycemia
Time frame: Within 24 hours of delivery
Percentage of neonates with hypoxic ischemic encephalopathy
Time frame: Within 72 hours of delivery
Percentage of neonates with hypothermia treatment
Time frame: Within 72 hours of delivery
Percentage of neonates with seizure
Time frame: 28 days of life
Percentage of neonates with respiratory distress
Time frame: Within 72 hours of delivery
umbilical artery base excess
Time frame: At delivery
umbilical artery partial pressure oxygen
Time frame: At delivery
umbilical artery partial pressure carbon dioxide
Time frame: At delivery
Percentage of patients with composite maternal morbidity
Time frame: Within 2 weeks of delivery
Apgars at 5 and 10 minutes
Time frame: At 5 and 10 minutes of neonatal life
Apgar<5 at 5 and 10 mins
Time frame: At 5 and 10 minutes of neonatal life
Percentage of neonates with Neonatal Intensive care unit admission
Time frame: Within 72 hours of delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Yes. The investigators will plan to share de-identified participant data and outcomes, study protocol, and analytic code via the NICHD Data and Specimen Hub (DASH).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal oxygen supplementation and Room air in people with Fetal Distress and Fetal Hypoxia, 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 6 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nandini Raghuraman, MD MSCI (3142732939, nraghuraman@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of neonates meeting criteria for composite neonatal morbidity (time frame: Up to 28 days of life). 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 10 Aug 2026.