Trial Outcomes & Findings for Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings (NCT NCT02741284)
NCT ID: NCT02741284
Last Updated: 2021-11-26
Results Overview
Determined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
At delivery
Results posted on
2021-11-26
Participant Flow
Participant milestones
| Measure |
Room Air
Room air, no mask
|
Oxygen
10L oxygen by nonrebreather mask
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings
Baseline characteristics by cohort
| Measure |
Room Air
n=51 Participants
Room air, no mask
|
Oxygen
n=48 Participants
10L oxygen by nonrebreather mask
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
27.3 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
27.5 years
STANDARD_DEVIATION 5.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
99 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Body mass index
|
27.7 kg/m2
STANDARD_DEVIATION 7.3 • n=99 Participants
|
26.9 kg/m2
STANDARD_DEVIATION 6.5 • n=107 Participants
|
27.3 kg/m2
STANDARD_DEVIATION 6.9 • n=206 Participants
|
|
Gestational age at delivery
|
39.1 weeks
STANDARD_DEVIATION 1.1 • n=99 Participants
|
39.2 weeks
STANDARD_DEVIATION 1.1 • n=107 Participants
|
39.1 weeks
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Nulliparity
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Chronic hypertension
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Preeclampsia
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Pregestational diabetes
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Tobacco use
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Illicit drug use
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Alcohol
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Induction of labor
|
36 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Oxytocin
|
45 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Chorioamnionitis
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Epidural
|
50 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Hematocrit on admission
|
32.5 Percentage of red blood cells
STANDARD_DEVIATION 3.2 • n=99 Participants
|
32.8 Percentage of red blood cells
STANDARD_DEVIATION 3.5 • n=107 Participants
|
32.6 Percentage of red blood cells
STANDARD_DEVIATION 3.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: At deliveryDetermined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.
Outcome measures
| Measure |
Room Air
n=51 Participants
Room air, no mask
|
Oxygen
n=48 Participants
10L oxygen by nonrebreather mask
|
|---|---|---|
|
Mean Umbilical Artery Lactate at Delivery
|
3.5 mmol/L
Interval 3.1 to 4.0
|
3.4 mmol/L
Interval 3.0 to 3.8
|
SECONDARY outcome
Timeframe: At time of deliveryDetermined by umbilical artery cord gas collected at time of delivery and only in patients with paired (umbilical artery and umbilical vein) cord gases.
Outcome measures
| Measure |
Room Air
n=51 Participants
Room air, no mask
|
Oxygen
n=48 Participants
10L oxygen by nonrebreather mask
|
|---|---|---|
|
Umbilical Artery pH
|
7.26 pH units
Interval 7.24 to 7.28
|
7.25 pH units
Interval 7.23 to 7.27
|
SECONDARY outcome
Timeframe: At deliveryDelivery via Cesarean section, operative vaginal delivery (forceps or vacuum), or spontaneous vaginal delivery
Outcome measures
| Measure |
Room Air
n=51 Participants
Room air, no mask
|
Oxygen
n=48 Participants
10L oxygen by nonrebreather mask
|
|---|---|---|
|
Mode of Delivery
Operative vaginal delivery
|
6 Participants
|
1 Participants
|
|
Mode of Delivery
Cesarean delivery
|
2 Participants
|
6 Participants
|
|
Mode of Delivery
Cesarean delivery for non reassuring fetal status
|
0 Participants
|
2 Participants
|
|
Mode of Delivery
Spontaenous vaginal delivery
|
43 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: At time of deliveryPartial pressure of carbon dioxide as collected on cord gases at time of delivery
Outcome measures
| Measure |
Room Air
n=51 Participants
Room air, no mask
|
Oxygen
n=48 Participants
10L oxygen by nonrebreather mask
|
|---|---|---|
|
Umbilical Artery pCO2
|
55.9 mmHg
Interval 53.5 to 58.2
|
57.4 mmHg
Interval 54.2 to 60.6
|
SECONDARY outcome
Timeframe: Time of deliveryPartial pressure of oxygen as collected on cord gases at time of delivery
Outcome measures
| Measure |
Room Air
n=51 Participants
Room air, no mask
|
Oxygen
n=48 Participants
10L oxygen by nonrebreather mask
|
|---|---|---|
|
Umbilical Artery pO2
|
19.7 mm Hg
Interval 17.5 to 22.0
|
24.4 mm Hg
Interval 20.0 to 28.8
|
SECONDARY outcome
Timeframe: At time of deliveryAs determined by cord gas collection at time of delivery
Outcome measures
| Measure |
Room Air
n=51 Participants
Room air, no mask
|
Oxygen
n=48 Participants
10L oxygen by nonrebreather mask
|
|---|---|---|
|
Umbilical Artery Base Deficit
|
-3.6 meq/L
Interval -4.3 to -2.9
|
-3.6 meq/L
Interval -4.3 to -2.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 60 minutes after randomizationNumber of patients with resolution of recurrent variable or recurrent late decelerations within 60 minutes of randomization
Outcome measures
| Measure |
Room Air
n=57 Participants
Room air, no mask
|
Oxygen
n=57 Participants
10L oxygen by nonrebreather mask
|
|---|---|---|
|
Number of Patients With Resolved Recurrent Decelerations
|
49 Participants
|
43 Participants
|
Adverse Events
Room Air
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxygen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Nandini Raghuraman
Washington University in St Louis
Phone: 314 362 7300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place