Trial Outcomes & Findings for Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate (NCT NCT03581214)
NCT ID: NCT03581214
Last Updated: 2025-04-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
910 participants
Primary outcome timeframe
At delivery
Results posted on
2025-04-15
Participant Flow
910 patients were enrolled. Of these, 698 did not get randomized. This was mostly because they did not ultimately meet randomization criteria (N=669), research staff were not available (N=53), or other logistical reasons (N=33).Of the 910 patients enrolled, 212 were randomized and included in the final analysis.
Participant milestones
| Measure |
Room Air
Room air (no mask)
No oxygen: No facemask, room air only
|
Oxygen
10L/min Oxygen by facemask
Oxygen: 10Liters/minute oxygen by facemask
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
106
|
|
Overall Study
COMPLETED
|
102
|
104
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intrapartum Maternal Oxygen Supplementation: Effects on the Mother and Neonate
Baseline characteristics by cohort
| Measure |
Room Air
n=102 Participants
Room air (no mask)
No oxygen: No facemask, room air only
|
Oxygen
n=104 Participants
10L/min Oxygen by facemask
Oxygen: 10Liters/minute oxygen by facemask
|
Total
n=206 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.1 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
27.2 years
STANDARD_DEVIATION 5.8 • n=107 Participants
|
27.1 years
STANDARD_DEVIATION 5.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
45 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=99 Participants
|
104 participants
n=107 Participants
|
206 participants
n=206 Participants
|
|
Insurance
Private
|
48 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Insurance
Public
|
46 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Insurance
Uninsured
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Insurance
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Pre-pregnancy obesity
|
31 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Nulliparous
|
56 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
115 Participants
n=206 Participants
|
|
Gestational diabetes
|
6 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Chronic Hypertension
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Induction of labor
|
71 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
|
Oxytocin
|
96 Participants
n=99 Participants
|
94 Participants
n=107 Participants
|
190 Participants
n=206 Participants
|
|
Epidural
|
97 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At deliveryOutcome measures
| Measure |
Room Air
n=79 Participants
Room air (no mask)
No oxygen: No facemask, room air only
|
Oxygen
n=74 Participants
10L/min Oxygen by facemask
Oxygen: 10Liters/minute oxygen by facemask
|
|---|---|---|
|
Umbilical Artery Malondialdehyde
|
9.8 umol/L
Interval 6.2 to 17.4
|
10.2 umol/L
Interval 6.6 to 15.8
|
PRIMARY outcome
Timeframe: At deliveryOutcome measures
| Measure |
Room Air
n=79 Participants
Room air (no mask)
No oxygen: No facemask, room air only
|
Oxygen
n=74 Participants
10L/min Oxygen by facemask
Oxygen: 10Liters/minute oxygen by facemask
|
|---|---|---|
|
Umbilical Artery 4-hydroxynonenal
|
34.1 pg/ml
Interval 10.6 to 155.2
|
29.5 pg/ml
Interval 10.6 to 145.0
|
PRIMARY outcome
Timeframe: Within 1 hour of deliveryOutcome measures
| Measure |
Room Air
n=80 Participants
Room air (no mask)
No oxygen: No facemask, room air only
|
Oxygen
n=79 Participants
10L/min Oxygen by facemask
Oxygen: 10Liters/minute oxygen by facemask
|
|---|---|---|
|
Maternal Malondialdehyde
|
2.8 mmol/L
Interval 2.1 to 3.9
|
2.5 mmol/L
Interval 1.8 to 3.6
|
PRIMARY outcome
Timeframe: Within 1 hour of deliveryOutcome measures
| Measure |
Room Air
n=76 Participants
Room air (no mask)
No oxygen: No facemask, room air only
|
Oxygen
n=74 Participants
10L/min Oxygen by facemask
Oxygen: 10Liters/minute oxygen by facemask
|
|---|---|---|
|
Maternal 4-hydroxynonenal
|
190.4 pg/ml
Interval 82.3 to 292.2
|
168.1 pg/ml
Interval 65.9 to 312.5
|
Adverse Events
Room Air
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Oxygen
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Room Air
n=102 participants at risk
Room air (no mask)
No oxygen: No facemask, room air only
|
Oxygen
n=104 participants at risk
10L/min Oxygen by facemask
Oxygen: 10Liters/minute oxygen by facemask
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Neonatal ICU stay > 72 hours
|
3.9%
4/102 • 72 hours post delivery
|
2.9%
3/104 • 72 hours post delivery
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal hypothermia treatment
|
0.98%
1/102 • 72 hours post delivery
|
0.00%
0/104 • 72 hours post delivery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place