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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Conditions Electronic Fetal Monitoring
Fetal Hypoxia
Fetal-Placental Circulation
Interventions Drug: Room air
Drug: 10L Oxygen by nonrebreather mask
Enrollment 114
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Room Air Oxygen
Hide Arm/Group Description Room air, no mask 10L oxygen by nonrebreather mask
Period Title: Overall Study
Started 57 57
Completed 51 48
Not Completed 6 9
Arm/Group Title Room Air Oxygen Total
Hide Arm/Group Description Room air, no mask 10L oxygen by nonrebreather mask Total of all reporting groups
Overall Number of Baseline Participants 51 48 99
Hide Baseline Analysis Population Description
Baseline characteristics were only compared in all patients included in the final analysis. (Randomized patients without paired umbilical cord gases were excluded from this analysis, as the primary outcome required paired cord gases). 48 out of 57 in oxygne and 51 out of 57 in room air had paired gases.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 51 participants 48 participants 99 participants
27.8  (5.3) 27.3  (6.3) 27.5  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
Female
51
 100.0%
48
 100.0%
99
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
3
   6.3%
3
   3.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
40
  78.4%
36
  75.0%
76
  76.8%
White
10
  19.6%
8
  16.7%
18
  18.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   2.0%
1
   2.1%
2
   2.0%
[1]
Measure Description: Baseline characteristics were only compared in patients with paired umbilical cord gases (51 in room air group, and 48 in oxygen group)
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 51 participants 48 participants 99 participants
27.7  (7.3) 26.9  (6.5) 27.3  (6.9)
Gestational age at delivery  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 51 participants 48 participants 99 participants
39.1  (1.1) 39.2  (1.1) 39.1  (1.1)
Nulliparity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
6
  11.8%
5
  10.4%
11
  11.1%
Chronic hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
6
  11.8%
3
   6.3%
9
   9.1%
Preeclampsia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
3
   5.9%
0
   0.0%
3
   3.0%
Pregestational diabetes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
Tobacco use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
8
  15.7%
6
  12.5%
14
  14.1%
Illicit drug use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
8
  15.7%
12
  25.0%
20
  20.2%
Alcohol  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
2
   3.9%
0
   0.0%
2
   2.0%
Induction of labor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
36
  70.6%
34
  70.8%
70
  70.7%
Oxytocin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
45
  88.2%
43
  89.6%
88
  88.9%
Chorioamnionitis  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
Epidural  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 48 participants 99 participants
50
  98.0%
44
  91.7%
94
  94.9%
Hematocrit on admission  
Mean (Standard Deviation)
Unit of measure:  Percentage of red blood cells
Number Analyzed 51 participants 48 participants 99 participants
32.5  (3.2) 32.8  (3.5) 32.6  (3.3)
1.Primary Outcome
Title Mean Umbilical Artery Lactate at Delivery
Hide Description Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.
Time Frame At delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Room Air Oxygen
Hide Arm/Group Description:
Room air, no mask
10L oxygen by nonrebreather mask
Overall Number of Participants Analyzed 51 48
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
3.5
(3.1 to 4.0)
3.4
(3.0 to 3.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Room Air, Oxygen
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments A noninferiority margin of 30% (mean difference <1.0 mmol/l) was pre-specified as it corresponds to an upper umbilical artery lactate cut-off value of 4.5 mmol/L, above which there is an increased risk of neonatal morbidity
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.5 to 0.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Umbilical Artery pH
Hide Description Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.
Time Frame At time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Room Air Oxygen
Hide Arm/Group Description:
Room air, no mask
10L oxygen by nonrebreather mask
Overall Number of Participants Analyzed 51 48
Mean (95% Confidence Interval)
Unit of Measure: pH units
7.26
(7.24 to 7.28)
7.25
(7.23 to 7.27)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Room Air, Oxygen
Comments pH
Type of Statistical Test Non-Inferiority
Comments Noninferiority margin 30%
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.01 to 0.03
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mode of Delivery
Hide Description Delivery via Cesarean section, operative vaginal delivery (forceps or vacuum), or spontaneous vaginal delivery
Time Frame At delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Room Air Oxygen
Hide Arm/Group Description:
Room air, no mask
10L oxygen by nonrebreather mask
Overall Number of Participants Analyzed 51 48
Measure Type: Count of Participants
Unit of Measure: Participants
Cesarean delivery
2
   3.9%
6
  12.5%
Cesarean delivery for non reassuring fetal status
0
   0.0%
2
   4.2%
Operative vaginal delivery
6
  11.8%
1
   2.1%
Spontaenous vaginal delivery
43
  84.3%
41
  85.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Room Air, Oxygen
Comments Cesarean delivery
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.32
Confidence Interval (2-Sided) 95%
0.07 to 1.48
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Room Air, Oxygen
Comments Cesarean delivery for non reassuring fetal status
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0
Confidence Interval (2-Sided) 95%
0 to 0
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Room Air, Oxygen
Comments Operative vaginal delivery
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 5.65
Confidence Interval (2-Sided) 95%
0.71 to 45.20
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Umbilical Artery pCO2
Hide Description Partial pressure of carbon dioxide as collected on cord gases at time of delivery
Time Frame At time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Room Air Oxygen
Hide Arm/Group Description:
Room air, no mask
10L oxygen by nonrebreather mask
Overall Number of Participants Analyzed 51 48
Mean (95% Confidence Interval)
Unit of Measure: mmHg
55.9
(53.5 to 58.2)
57.4
(54.2 to 60.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Room Air, Oxygen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-5.4 to 2.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Umbilical Artery pO2
Hide Description Partial pressure of oxygen as collected on cord gases at time of delivery
Time Frame Time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Room Air Oxygen
Hide Arm/Group Description:
Room air, no mask
10L oxygen by nonrebreather mask
Overall Number of Participants Analyzed 51 48
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
19.7
(17.5 to 22.0)
24.4
(20.0 to 28.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Room Air, Oxygen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.7
Confidence Interval (2-Sided) 95%
-9.6 to 0.1
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Umbilical Artery Base Deficit
Hide Description As determined by cord gas collection at time of delivery
Time Frame At time of delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Room Air Oxygen
Hide Arm/Group Description:
Room air, no mask
10L oxygen by nonrebreather mask
Overall Number of Participants Analyzed 51 48
Mean (95% Confidence Interval)
Unit of Measure: meq/L
-3.6
(-4.3 to -2.9)
-3.6
(-4.3 to -2.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Room Air, Oxygen
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-1.0 to 1.0
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Resolution of Recurrent Decelerations
Hide Description [Not Specified]
Time Frame 60 minutes after randomization
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Umbilical Artery Malondialdehyde Concentration
Hide Description [Not Specified]
Time Frame At delivery
Outcome Measure Data Not Reported
Time Frame Until neonate was discharged from hospital. (Up to 1 month after delivery)
Adverse Event Reporting Description Does not differ from clinicaltrials.gov definitions
 
Arm/Group Title Room Air Oxygen
Hide Arm/Group Description Room air, no mask 10L oxygen by nonrebreather mask
All-Cause Mortality
Room Air Oxygen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%) 
Hide Serious Adverse Events
Room Air Oxygen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Room Air Oxygen
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Nandini Raghuraman
Organization: Washington University in St Louis
Phone: 314 362 7300
EMail: nraghuraman@wustl.edu
Publications:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02741284    
Other Study ID Numbers: 201602164
First Submitted: April 10, 2016
First Posted: April 18, 2016
Results First Submitted: May 4, 2018
Results First Posted: November 2, 2018
Last Update Posted: February 10, 2020