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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02741284
Other study ID # 201602164
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date December 2020

Study information

Verified date November 2021
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Description:

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Study Design


Intervention

Drug:
Room air

10L Oxygen by nonrebreather mask


Locations

Country Name City State
United States Barnes Jewish Hospital Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (16)

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Outcome

Type Measure Description Time frame Safety issue
Other Number of Patients With Resolved Recurrent Decelerations Number of patients with resolution of recurrent variable or recurrent late decelerations within 60 minutes of randomization 60 minutes after randomization
Primary Mean Umbilical Artery Lactate at Delivery Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases. At delivery
Secondary Umbilical Artery pH Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases. At time of delivery
Secondary Mode of Delivery Delivery via Cesarean section, operative vaginal delivery (forceps or vacuum), or spontaneous vaginal delivery At delivery
Secondary Umbilical Artery pCO2 Partial pressure of carbon dioxide as collected on cord gases at time of delivery At time of delivery
Secondary Umbilical Artery pO2 Partial pressure of oxygen as collected on cord gases at time of delivery Time of delivery
Secondary Umbilical Artery Base Deficit As determined by cord gas collection at time of delivery At time of delivery
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