NCT05681624 Maternal Oxygen Supplementation for Intrauterine Resuscitation
| NCT ID | NCT05681624 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Fetal Distress |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,124 participants |
| Start Date | 2023-05-22 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,124 participants in total. It began in 2023-05-22 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Singleton gestation * Gestational age\>=37 weeks * Spontaneous labor or induction of labor * English or spanish speaking * Planned continuous fetal monitoring Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05681624 clinical trial?
This trial is open to female participants only, studying Fetal Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05681624 currently recruiting?
Yes, NCT05681624 is actively recruiting participants. Contact the research team at nraghuraman@wustl.edu for enrollment information.
Where is the NCT05681624 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05681624 clinical trial?
NCT05681624 is sponsored by Washington University School of Medicine. The trial plans to enroll 2,124 participants.