Oxygen supplementation for mothers during labor to help babies in distress
Maternal Oxygen Supplementation for Intrauterine Resuscitation: a Multicenter Randomized Trial
This study is testing if giving extra oxygen to mothers during labor can help their babies who are in distress feel better and avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2124 (estimated) |
| Sex | Female |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05681624 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of maternal oxygen supplementation on fetal distress and hypoxia during labor. It aims to determine whether providing oxygen to mothers can improve oxygen transfer to their babies, potentially reducing complications associated with fetal monitoring. The study will include women with singleton pregnancies who are at least 37 weeks gestation and undergoing continuous fetal monitoring. Participants will be randomly assigned to receive either oxygen supplementation or room air during labor.
Who should consider this trial
Good fit: Ideal candidates are pregnant women with singleton gestations at 37 weeks or more who are in spontaneous or induced labor and require continuous fetal monitoring.
Not a fit: Patients who are preterm, have major fetal anomalies, or are undergoing planned cesarean deliveries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve outcomes for babies experiencing fetal distress during labor.
How similar studies have performed: There is conflicting evidence regarding the efficacy of oxygen supplementation during labor, with some studies showing continued use despite lack of definitive data, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
St Louis, Missouri
- Barnes Jewish Hospital — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Nandini Raghuraman, MD MSCI
- Email: nraghuraman@wustl.edu
- Phone: 3142732939
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.