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Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings (O2C2)

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ClinicalTrials.gov Identifier: NCT02741284
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Results First Posted : November 2, 2018
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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

Condition or disease Intervention/treatment Phase
Electronic Fetal Monitoring Fetal Hypoxia Fetal-Placental Circulation Drug: Room air Drug: 10L Oxygen by nonrebreather mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Oxygen for Category II Intrauterine Fetal Resuscitation: A Randomized, Noninferiority Trial
Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: No Oxygen
Room air
Drug: Room air
Active Comparator: Oxygen
10L oxygen by nonrebreather mask
Drug: 10L Oxygen by nonrebreather mask



Primary Outcome Measures :
  1. Mean Umbilical Artery Lactate at Delivery [ Time Frame: 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.


Secondary Outcome Measures :
  1. Umbilical Artery pH [ Time Frame: At time of 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.

  2. Mode of Delivery [ Time Frame: At delivery ]
    Delivery via Cesarean section, operative vaginal delivery (forceps or vacuum), or spontaneous vaginal delivery

  3. Umbilical Artery pCO2 [ Time Frame: At time of delivery ]
    Partial pressure of carbon dioxide as collected on cord gases at time of delivery

  4. Umbilical Artery pO2 [ Time Frame: Time of delivery ]
    Partial pressure of oxygen as collected on cord gases at time of delivery

  5. Umbilical Artery Base Deficit [ Time Frame: At time of delivery ]
    As determined by cord gas collection at time of delivery


Other Outcome Measures:
  1. Resolution of Recurrent Decelerations [ Time Frame: 60 minutes after randomization ]
  2. Umbilical Artery Malondialdehyde Concentration [ Time Frame: At delivery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Term, singleton patients admitted to Labor& Delivery for spontaneous labor or labor induction

Exclusion Criteria:

  • Multiple pregnancy
  • Significant fetal anomalies
  • Category III FHT
  • Umbilical artery doppler abnormalities
  • Maternal hypooxygenation or need for oxygen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741284


Locations
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United States, Missouri
Barnes Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02741284    
Other Study ID Numbers: 201602164
First Posted: April 18, 2016    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: August 18, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Fetal Hypoxia
Hypoxia
Signs and Symptoms, Respiratory
Fetal Diseases
Pregnancy Complications