CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 844 enrolled
Drug / intervention
Liberal use of maternal oxygen +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.

Search/NCT02752490
NCT02752490N/ACompleted

The Comparative Effectiveness of Liberal Versus Restricted Maternal Administration of Oxygen During Labor: a Controlled Before and After Study

The University of Texas Health Science Center, Houston·interventional·Posted Apr 27, 2016·Updated Oct 12, 2020

In Brief

A clinical study evaluating Liberal use of maternal oxygen and Indicated use of maternal oxygen for Maternal Oxygen Use in Labor. Completed, enrolled 844 participants across 1 site.

Detailed Summary

The objective of this study is to determine if a strategy of indicated compared to liberal oxygen administration in labor decreases the rate of cesarean delivery. The hypothesis is that women who undergo a strategy of indicated compared to liberal oxygen administration in labor will have lower rate of cesarean delivery and fetal acidemia at birth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 27, 2016
Enrollment StartApr 1, 2016
Primary CompletionJul 31, 2016
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.2 years ago

Interventions

Liberal use of maternal oxygendrug

Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by ACOG10 at the discretion of the primary nurse or physician

Indicated use of maternal oxygendrug

Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.