Trial Outcomes & Findings for Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes (NCT NCT02121184)
NCT ID: NCT02121184
Last Updated: 2024-05-29
Results Overview
Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
172 participants
Primary outcome timeframe
Request for labor analgesia up to the first 60 minutes after the epidural placement
Results posted on
2024-05-29
Participant Flow
Participant milestones
| Measure |
Routine Oxytocin
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. Oxytocin management will continue as per the routine oxytocin protocol
Routine oxytocin: per regular oxytocin protocols
|
Half- Dose Oxytocin
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. A half-dose oxytocin will be initiated and not increased until 60 minutes after.
Half-dose oxytocin: The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
|
Overall Study
COMPLETED
|
84
|
83
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Routine Oxytocin
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. Oxytocin management will continue as per the routine oxytocin protocol
Routine oxytocin: per regular oxytocin protocols
|
Half- Dose Oxytocin
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. A half-dose oxytocin will be initiated and not increased until 60 minutes after.
Half-dose oxytocin: The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
|
|---|---|---|
|
Overall Study
No oxytoxin administered prior to combined spinal epidural catheter placement
|
1
|
0
|
|
Overall Study
Multiple parasthesias at time after combined spinal epidural catheter placement
|
0
|
1
|
|
Overall Study
Emergency cesarean section required
|
0
|
2
|
|
Overall Study
Combined spinal epidural completed without notifying study team
|
1
|
0
|
Baseline Characteristics
Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Baseline characteristics by cohort
| Measure |
Group A
n=86 Participants
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. Oxytocin management will continue as per the routine oxytocin protocol
Routine oxytocin: per regular oxytocin protocols
|
Group B
n=86 Participants
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. A half-dose oxytocin will be initiated and not increased until 60 minutes after.
Half-dose oxytocin: The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.9 Years
n=99 Participants
|
32.35 Years
n=107 Participants
|
32.5 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=99 Participants
|
77 Participants
n=107 Participants
|
160 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
114 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
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Fetus gestational age in weeks
|
39 Weeks
n=99 Participants
|
39.3 Weeks
n=107 Participants
|
39.1 Weeks
n=206 Participants
|
|
Maternal weight
|
80.31 Kilograms
n=99 Participants
|
79.26 Kilograms
n=107 Participants
|
79.7 Kilograms
n=206 Participants
|
|
Maternal Mean Arterial Pressure
|
92.06 millimeters mercury
n=99 Participants
|
89.94 millimeters mercury
n=107 Participants
|
91.07 millimeters mercury
n=206 Participants
|
|
Oxytocin dose at start of epidural procedure
|
7.39 milliunits/mL
n=99 Participants
|
8.38 milliunits/mL
n=107 Participants
|
7.9 milliunits/mL
n=206 Participants
|
PRIMARY outcome
Timeframe: Request for labor analgesia up to the first 60 minutes after the epidural placementPopulation: Data was not collected as the OB/MD who was a certified fetal heart rate evaluator on the team (OB/MD) left Northwestern University. The fetal heart rate data can only be collected, scored and analyzed by a certified fetal heart rate evaluator and there are none available for this project.
Incidence of non-reassuring fetal heart rate tracings during the first 60 minutes after the placement of epidural analgesia
Outcome measures
Outcome data not reported
Adverse Events
Group A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=86 participants at risk
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. Oxytocin management will continue as per the routine oxytocin protocol
Routine oxytocin: per regular oxytocin protocols
|
Group B
n=86 participants at risk
Lactated Ringers bolus of 1000 mL will be initiated when the patient is positioned for epidural placement. A half-dose oxytocin will be initiated and not increased until 60 minutes after.
Half-dose oxytocin: The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/86 • Adverse events were collected up to 7 days after study intervention.
|
0.00%
0/86 • Adverse events were collected up to 7 days after study intervention.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place