Maternal Oxygen Supplementation for Intrauterine Resuscitation
Washington University School of Medicine · with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Michigan · NCT05681624
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Any age listed · Women only
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 2252
- US sites recruiting
- 1
- Study start
- May 22, 2023
- Record last updated
- August 10, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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 studied: Maternal oxygen supplementation; Room air
Conditions: Fetal Distress; Fetal Hypoxia; Labor and Delivery Complication
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Barnes Jewish Hospital
St Louis, MO 63110
Site contact: Nandini Raghuraman, MD MS
Study contacts (from the official record)
- Nandini Raghuraman, MD MSCI · 3142732939 · nraghuraman@wustl.edu
Similar studies in Missouri
All healthy volunteers studies in Missouri →- RecruitingHealthy volunteersPhase 1
A Study of V132 in Healthy Older Participants (V132-001)
Merck Sharp & Dohme LLC
- Location
- Springfield, MO + 9 other US sites
- Eligibility basics
- Ages 50–75
- RecruitingHealthy volunteersPhase 1
A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)
Merck Sharp & Dohme LLC
- Location
- Springfield, MO + 5 other US sites
- Eligibility basics
- Ages 18–64
- RecruitingHealthy volunteersPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
Haya Therapeutics, Inc.
- Location
- Kansas City, MO + 1 other US site
- Eligibility basics
- Ages 18–70
- RecruitingHealthy volunteersPhase 1
A Clinical Study of Novel Pneumococcal Vaccine V118C in Children (V118C-002)
Merck Sharp & Dohme LLC
- Location
- St Louis, MO + 14 other US sites
- Eligibility basics
- Ages 2 mo–1