Maternal Oxygen Supplementation for Fetal Distress

(MOXY Trial)

Recruiting at 1 trial location

Overseen By Nandini Raghuraman, MD MSCI

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Nitrous oxide

Disqualifiers: Preterm gestation, Major fetal anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During labor

2124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether giving oxygen to pregnant women in labor benefits babies showing signs of stress, compared to breathing regular air. The researchers aim to determine if oxygen supplementation (also known as Maternal Oxygen Supplementation) is safe and effective for both babies and mothers during labor. This study is crucial because current medical guidelines disagree on the use of oxygen in these situations. Women who are at least 37 weeks pregnant, in labor, and carrying a single baby are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to vital research that could clarify medical guidelines and improve care for future mothers and babies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Past studies have not clearly established the safety of giving oxygen to mothers during labor. Some research has shown that short periods of oxygen can alter the baby's blood flow, but the effects remain uncertain. Other studies suggest that oxygen might impact the baby's acid-base balance, which is crucial for health. Experts continue to debate whether using oxygen for fetal distress is safe and beneficial. More high-quality research is needed to provide clear answers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring maternal oxygen supplementation for addressing fetal distress because it offers a potentially immediate intervention that is non-invasive and widely accessible. Unlike other treatments for fetal distress, which may involve more invasive procedures or medications, administering oxygen to the mother can be a simple and fast way to improve fetal oxygenation. This approach could provide a safer and more convenient option for both mothers and babies, particularly in emergency situations where time is critical.

What evidence suggests that maternal oxygen supplementation could be effective for fetal distress?

This trial will compare Maternal Oxygen Supplementation with Room Air for fetal distress. Research has shown insufficient evidence to determine if extra oxygen for mothers during labor benefits their babies. Some studies suggest that oxygen does not improve an abnormal fetal heart rate. Consequently, uncertainty remains about oxygen's effectiveness for the baby. Experts hold differing opinions on using oxygen in these situations. More research is needed to determine if oxygen can truly make a difference. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for pregnant women at or beyond 37 weeks of gestation, in spontaneous labor or induction, who speak English or Spanish and are having single babies with planned continuous fetal monitoring. It excludes those scheduled for cesarean delivery, with the most severe fetal heart rate issues (Category III), major fetal anomalies, multiple pregnancies, maternal oxygen levels below 95%, or preterm gestation.

Inclusion Criteria

Planned continuous fetal monitoring

You are pregnant with only one baby.

My pregnancy has reached or passed 37 weeks.

Exclusion Criteria

You were born prematurely.

Planned or scheduled cesarean delivery

You are in the third category of fetal monitoring when you are admitted.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oxygen supplementation or room air during labor with Category II EFM

During labor

Follow-up

Participants are monitored for neonatal and maternal morbidity outcomes

Up to 28 days

What Are the Treatments Tested in This Trial?

Interventions

• Maternal Oxygen Supplementation
• Room Air

Trial Overview The study tests whether giving extra oxygen to mothers during labor when there's a concern about the baby's oxygen supply (Category II EFM) is safe and effective compared to just breathing room air. This large study will randomly assign participants to either receive supplemental oxygen or breathe normal air to see which is better.

How Is the Trial Designed?

Group I: Oxygen Experimental Treatment 1 Intervention

Group II: Room air Active Control 1 Intervention

Maternal Oxygen Supplementation is already approved in United States, European Union for the following indications:

Approved in United States as Oxygen Therapy for:

• Intrauterine resuscitation in cases of indeterminate or abnormal fetal heart rate patterns

Approved in European Union as Oxygen Therapy for:

• Intrauterine resuscitation in cases of indeterminate or abnormal fetal heart rate patterns

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of Texas at Austin

Collaborator

Trials

387

Recruited

86,100+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Dell Children's Medical Center of Central Texas

Collaborator

Trials

7

Recruited

5,004,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Published Research Related to This Trial

In a study involving 46 pregnant women in their third trimester, brief hyperoxygenation (100% oxygen for 10 minutes) led to a significant decrease in cardiac index and an increase in systemic vascular resistance, indicating potential negative effects on maternal circulation.

Unlike the pregnant group, the nonpregnant group (20 women) showed no significant hemodynamic changes during hyperoxygenation, suggesting that the physiological response to supplemental oxygen differs between pregnant and nonpregnant individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperoxygenation in pregnancy exerts a more profound effect on cardiovascular hemodynamics than is observed in the nonpregnant state. McHugh, A., El-Khuffash, A., Bussmann, N., et al.[2019]

There is insufficient evidence to support the use of maternal oxygen therapy during labor for fetal distress, as no trials specifically addressed this issue.

In the two trials that examined prophylactic oxygen administration, it was found that abnormal cord blood pH values were significantly more frequent in the oxygen group compared to the control group, suggesting potential harm rather than benefit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal oxygen administration for fetal distress. Fawole, B., Hofmeyr, GJ.[2021]

A review found no randomized trials supporting the use of maternal oxygen therapy for fetal distress during labor, indicating a lack of evidence for its effectiveness.

In a single trial involving 85 women, those who received prophylactic oxygen therapy had a higher incidence of low cord blood pH values compared to the control group, suggesting potential harm rather than benefit from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal oxygen administration for fetal distress. Hofmeyr, GJ.[2018]

Oxygen therapy is crucial in treating hypoxemia in acute care, but excessive oxygen supplementation can lead to harmful effects, known as hyperoxemia.

The article emphasizes the importance of following current recommendations for safe oxygen supplementation to avoid the negative consequences associated with too much oxygen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oxygen toxicity in acute care settings]. Lévy, C., Schmit, A., Younossian, AB., et al.[2019]

Maternal oxygen supplementation during labor does not appear to benefit fetal health, as indicated by the results of the only two randomized trials conducted on this topic.

There is a potential risk associated with maternal oxygen supplementation, as it may increase free radical activity, suggesting that it should only be used in cases of maternal hypoxia and not for nonreassuring fetal heart rate patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxygen for intrauterine resuscitation: of unproved benefit and potentially harmful. Hamel, MS., Anderson, BL., Rouse, DJ.[2015]

The review found no evidence supporting the use of maternal oxygen therapy for fetal distress during labor, and two trials on prophylactic oxygen administration showed that it was associated with a significantly higher risk of abnormal cord blood pH values (less than 7.2).

Given the potential risks and lack of efficacy demonstrated, there is an urgent need for further randomized trials to evaluate the effects of oxygen therapy during labor, as current practices may be ineffective or harmful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal oxygen administration for fetal distress. Fawole, B., Hofmeyr, GJ.[2018]

In a study of 130 healthy women undergoing elective cesarean delivery, the use of supplemental oxygen did not significantly impact neonatal well-being as measured by Apgar scores or umbilical cord blood gases.

While maternal oxygen saturation was higher in the supplemental oxygen group, the differences in neonatal outcomes, including blood gas measurements, were not clinically significant, indicating that oxygen therapy may not be necessary for healthy parturients during cesarean sections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is oxygen therapy truly useful and necessary during elective cesarean section under spinal anesthesia?]. Palacio, F., Ortiz-Gómez, JR., Fornet, I., et al.[2019]

There is a lack of strong evidence supporting the use of oxygen therapy for women in labor to improve fetal health, despite its common practice.

Relying on maternal oxygen administration may lead to delays in necessary medical interventions for the fetus, highlighting the need for well-designed clinical trials to determine its actual effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whither oxygen for intrauterine resuscitation? Hamel, MS., Hughes, BL., Rouse, DJ.[2018]

Maternal hyperoxygenation has been explored since the 1960s as a potential treatment for various obstetric conditions, but there is still no clear evidence supporting its benefits, particularly for fetal growth restriction.

Research on maternal oxygen therapy for fetal congenital cardiac disease has shown mixed results and raised concerns about possible adverse effects, highlighting the need for careful consideration before conducting further clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calling into question the future of hyperoxygenation in pregnancy. McHugh, A., El-Khuffash, A., Franklin, O., et al.[2021]

In a study of 99 laboring patients, prolonged exposure to supplemental oxygen during labor did not increase umbilical cord oxygen levels; in fact, it was associated with lower oxygen levels in the umbilical vein, indicating potential harm.

The findings suggest that longer durations of oxygen supplementation may impair placental oxygen transfer, raising concerns about the safety and efficacy of this common resuscitation technique during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The duration of intrapartum supplemental oxygen administration and umbilical cord oxygen content. Watkins, VY., Martin, S., Macones, GA., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7045413/

Maternal oxygen administration for fetal distress - PMC A review of two trials found too little evidence to show whether oxygen administration to the woman during the second stage of labour is beneficial to the baby.

2. mdpi.com mdpi.com/2227-9067/10/8/1420

Maternal Oxygen Administration during Labor There is no evidence that maternal oxygen administration can provide any benefit in the case of a non-reassuring fetal heart rate pattern.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07927-y

Effect of maternal oxygen supplementation for parturient ... The purpose of this study is to determine whether maternal oxygen supplementation with HFNO has a positive effect on fetal acidemia during cesarean section.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05681624

Maternal Oxygen Supplementation for Intrauterine ... 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.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10191681/

Intrapartum Oxygen for Fetal Resuscitation: State of the ... This review aims to summarize the current evidence regarding maternal oxygen supplementation for Category II fetal heart tracings (FHT) in labor.

6. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02456-z

Maternal oxygen inhalation affects the fetal hemodynamic in ... Our study found that brief maternal oxygen inhalation in the third trimester was associated with significant changes in fetal hemodynamics, specifically higher ...