Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02741284
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Results First Posted : November 2, 2018
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE April 10, 2016
First Posted Date  ICMJE April 18, 2016
Results First Submitted Date  ICMJE May 4, 2018
Results First Posted Date  ICMJE November 2, 2018
Last Update Posted Date February 10, 2020
Study Start Date  ICMJE June 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
Mean Umbilical Artery Lactate at Delivery [ Time Frame: At delivery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • 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.
  • Mode of Delivery [ Time Frame: At delivery ]
    Delivery via Cesarean section, operative vaginal delivery (forceps or vacuum), or spontaneous vaginal delivery
  • Umbilical Artery pCO2 [ Time Frame: At time of delivery ]
    Partial pressure of carbon dioxide as collected on cord gases at time of delivery
  • Umbilical Artery pO2 [ Time Frame: Time of delivery ]
    Partial pressure of oxygen as collected on cord gases at time of delivery
  • Umbilical Artery Base Deficit [ Time Frame: At time of delivery ]
    As determined by cord gas collection at time of delivery
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
  • Number of women with persistent Category II Fetal Heart Tracing after intervention [ Time Frame: From time of randomization until time of delivery ]
  • Mean umbilical artery measurement of malondialdehyde as marker of free radical activity [ Time Frame: At delivery ]
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2018)
  • Resolution of Recurrent Decelerations [ Time Frame: 60 minutes after randomization ]
  • Umbilical Artery Malondialdehyde Concentration [ Time Frame: At delivery ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings
Official Title  ICMJE Oxygen for Category II Intrauterine Fetal Resuscitation: A Randomized, Noninferiority Trial
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
Detailed Description

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. Category II FHT, as defined by the National Institute of Child Health and Human Development (NICHD) (Robinson), is a broad class of FHT patterns that may suggest cord compression and/or placental insufficiency for which oxygen is most commonly administered. Although some animal and human studies (Khazin, Althabe) have demonstrated that maternal hyperoxygenation can alleviate such fetal heart rate decelerations, this purported benefit has not been shown to translate into improved fetal outcomes, particularly in relation to acid-base status. In fact, some studies suggest harm with oxygen use due to lower umbilical artery pH and increased delivery room resuscitation (Nesterenko, Thorp) or increased free radical activity (Khaw). Given the indeterminate evidence for this ubiquitously employed resuscitation technique, there is an urgent need to further study the utility of maternal oxygen administration in labor for fetal benefit.

We propose a randomized controlled non-inferiority trial comparing oxygen to room air in patients with Category II FHT. Our central hypothesis is that room air alone is not inferior to oxygen administration with regard to neonatal acid-base status and FHT and may in fact, be a safer option for resuscitation due to less production of reactive oxygen species.

Primary Aim: Determine the effect of maternal oxygen administration for Category II FHT on arterial umbilical cord lactate.

Hypothesis: Room air, as a substitute for oxygen supplementation, is no different than oxygen in altering the acid-base status of the neonate as reflected in umbilical arterial (UA) lactate.

Fetal hypo-oxygenation, as reflected by decelerations in the FHT, results in metabolic acidosis due to a shift from aerobic to anaerobic metabolism in which lactate and hydrogen ion production significantly increase causing a decrease in pH (Tuuli). Elevated umbilical cord lactate has been shown to be a surrogate for fetal metabolic acidosis and resultant neonatal morbidity (Tuuli, Westgren). The theorized benefit of maternal oxygen administration is increased oxygen delivery to the fetus resulting in reversal of anaerobic metabolism/ metabolic acidosis. This, however, has not been substantiated by evidence thus far. Women with persistent Category II FHT tracing will be randomly assigned to supplemental oxygen or room air. The primary outcome will be umbilical arterial lactate level, and secondary outcomes will be other umbilical cord gas parameters including UA pH, UV oxygen saturation, and UA base deficit.

Secondary Aim #1: Characterize the effect of oxygen administration on fetal heart tracing patterns Hypothesis: Oxygen administration will be associated with a rate of persistent Category II FHT that is not different from those exposed to room air.

Oxygen is typically administered as a response to FHT interpretation. Evidence thus far shows that Category II FHT are associated with a wide spectrum of neonatal outcomes and therefore do not uniformly reflect fetal acid-base status (Cahill, Frey). Hence, evaluating the effect of oxygen on subsequent FHT categorization is pivotal to labor management. The outcome that will be investigated is rate of persistent Category II FHT after intervention.

Secondary Aim #2: Evaluate the safety of oxygen administration by measuring reactive oxygen species (ROS) in maternal and neonatal blood.

Hypothesis: Oxygen administration will be associated with increased oxidative stress in maternal and neonatal cord blood as represented by malondialdehyde (MDA).

Over-oxygenation can result in free radical or ROS formation that have detrimental downstream effects. The presence of reactive oxygen species results in degradation of lipids in the cell membrane and resultant formation of malondialdehyde (MDA) (Dalle-Donne), which has been studied as a surrogate for oxidative stress (Ilhan, Pryor, Suhail, Lorente).

This study will be a prospective, randomized non inferiority trial to be conducted a single center. This study will include term, singleton patients admitted to Labor& Delivery for spontaneous labor or labor induction. Multiples, significant fetal anomalies, Category III FHT, umbilical artery doppler abnormalities and preterm pregnancies will be excluded. Additionally, women will be excluded if oxygen is required for maternal indications such as hypooxygenation or cardiopulmonary disease. Our primary objective will be umbilical cord lactate. Secondary objectives include additional cord gas parameters including umbilical artery pH, umbilical artery base deficit, and umbilical vein oxygen saturation; FHT categorization and deceleration patterns; maternal and umbilical cord blood measurement of malondialdehyde. Women will be consented at time of admission for labor and randomized when at least 6cm dilated with Category II FHT necessitating provider intervention.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Electronic Fetal Monitoring
  • Fetal Hypoxia
  • Fetal-Placental Circulation
Intervention  ICMJE
  • Drug: Room air
  • Drug: 10L Oxygen by nonrebreather mask
Study Arms  ICMJE
  • Experimental: No Oxygen
    Room air
    Intervention: Drug: Room air
  • Active Comparator: Oxygen
    10L oxygen by nonrebreather mask
    Intervention: Drug: 10L Oxygen by nonrebreather mask
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
114
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2016)
120
Estimated Study Completion Date  ICMJE June 2020
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02741284
Other Study ID Numbers  ICMJE 201602164
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Washington University School of Medicine
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP