At a glance
ClinicalIndex Comparison RecordN/ACompleted· 114 enrolled
Drug / intervention
Room air +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Oxygen for Category II Intrauterine Fetal Resuscitation: A Randomized, Noninferiority Trial
In Brief
A clinical study evaluating Room air and 10L Oxygen by nonrebreather mask for Electronic Fetal Monitoring and 2 related conditions. Completed, enrolled 114 participants across 1 site.
Detailed Summary
Maternal oxygen administration for concerning fetal heart rate tracing (FHT) patterns is common practice on Labor and Delivery units in the United States. Despite the broad use of oxygen, it is unclear if this practice is beneficial for the fetus. The purpose of this study is to compare oxygen to room air in patients with Category II fetal heart tracings with regard to neonatal acid-base status, subsequent tracings, and production of reactive oxygen species
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartJun 2016
Primary CompletionJun 2017
Study CompletionDec 2020
TodayJul 2026
First PostedApr 18, 2016
Enrollment StartJun 1, 2016
Primary CompletionJun 1, 2017
Study CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.2 years ago
Interventions
Room airdrug
10L Oxygen by nonrebreather maskdrug