Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05681624
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2022-12-14
Brief Title:
Maternal Oxygen Supplementation for Intrauterine Resuscitation
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Maternal Oxygen Supplementation for Intrauterine Resuscitation a Multicenter Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOXY
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 andor 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 Womens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD108614 | NIH | None | httpsreporternihgovquickSearchR01HD108614 |