Trial Outcomes & Findings for The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes (NCT NCT00787176)
NCT ID: NCT00787176
Last Updated: 2022-01-13
Results Overview
The number of participants who experience non-reassuring fetal heart rate tracings obtained via electronic recording during the first 30 minutes after the placement of epidural analgesia
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
251 participants
Primary outcome timeframe
Request for labor analgesia up to the first 30 minutes after the placement of epidural
Results posted on
2022-01-13
Participant Flow
Participant milestones
| Measure |
Group A Full Oxytocin 1000 ml LR
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
|
Group B 1/2 Oxytocin 1000 ml LR
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Group C Full Oxytocin No LR
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
|
Group D 1/2 Oxytocin no Additional LR
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
69
|
62
|
60
|
60
|
|
Overall Study
COMPLETED
|
62
|
59
|
54
|
55
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
6
|
5
|
Reasons for withdrawal
| Measure |
Group A Full Oxytocin 1000 ml LR
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
|
Group B 1/2 Oxytocin 1000 ml LR
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Group C Full Oxytocin No LR
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
|
Group D 1/2 Oxytocin no Additional LR
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
|---|---|---|---|---|
|
Overall Study
Low quality fetal heart rate tracing
|
7
|
3
|
6
|
5
|
Baseline Characteristics
The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes
Baseline characteristics by cohort
| Measure |
Group A
n=69 Participants
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
|
Group B
n=62 Participants
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Group C
n=60 Participants
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
|
Group D
n=60 Participants
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
251 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
31.14 Years
STANDARD_DEVIATION 4.97 • n=5 Participants
|
30.50 Years
STANDARD_DEVIATION 5.27 • n=7 Participants
|
31.15 Years
STANDARD_DEVIATION 4.34 • n=5 Participants
|
30.42 Years
STANDARD_DEVIATION 5.88 • n=4 Participants
|
30.8 Years
STANDARD_DEVIATION 5.12 • n=21 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
251 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
62 participants
n=7 Participants
|
60 participants
n=5 Participants
|
60 participants
n=4 Participants
|
251 participants
n=21 Participants
|
|
Body Mass Index (kg/m∧ 2)
|
29.64 (kg/m∧ 2)
STANDARD_DEVIATION 4.49 • n=5 Participants
|
28.26 (kg/m∧ 2)
STANDARD_DEVIATION 3.63 • n=7 Participants
|
30.77 (kg/m∧ 2)
STANDARD_DEVIATION 6.1 • n=5 Participants
|
30.51 (kg/m∧ 2)
STANDARD_DEVIATION 5.96 • n=4 Participants
|
29.8 (kg/m∧ 2)
STANDARD_DEVIATION 5.05 • n=21 Participants
|
|
Estimated Gestational Age (weeks)
|
39.18 Weeks
STANDARD_DEVIATION 1.17 • n=5 Participants
|
39.06 Weeks
STANDARD_DEVIATION 1.21 • n=7 Participants
|
39.6 Weeks
STANDARD_DEVIATION 1.04 • n=5 Participants
|
39.02 Weeks
STANDARD_DEVIATION 1.34 • n=4 Participants
|
39.22 Weeks
STANDARD_DEVIATION 1.19 • n=21 Participants
|
|
Baseline oxytocin (milliunit/minute)
|
6.54 (milliunit/minute)
STANDARD_DEVIATION 4.64 • n=5 Participants
|
6.65 (milliunit/minute)
STANDARD_DEVIATION 4.04 • n=7 Participants
|
6.15 (milliunit/minute)
STANDARD_DEVIATION 5.16 • n=5 Participants
|
5.88 (milliunit/minute)
STANDARD_DEVIATION 4.26 • n=4 Participants
|
6.3 (milliunit/minute)
STANDARD_DEVIATION 4.5 • n=21 Participants
|
|
Cervical Dilation (cm)
|
3.54 centimeters
STANDARD_DEVIATION 1.10 • n=5 Participants
|
3.72 centimeters
STANDARD_DEVIATION 1.01 • n=7 Participants
|
3.6 centimeters
STANDARD_DEVIATION 1.32 • n=5 Participants
|
3.52 centimeters
STANDARD_DEVIATION 1.01 • n=4 Participants
|
3.6 centimeters
STANDARD_DEVIATION 1.11 • n=21 Participants
|
|
Number of times pregnant
1 pregnancy
|
36 participants
n=5 Participants
|
38 participants
n=7 Participants
|
33 participants
n=5 Participants
|
40 participants
n=4 Participants
|
147 participants
n=21 Participants
|
|
Number of times pregnant
2 pregnancies
|
20 participants
n=5 Participants
|
9 participants
n=7 Participants
|
14 participants
n=5 Participants
|
8 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
Number of times pregnant
3 pregnancies
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Number of times pregnant
4 pregnancies
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
14 participants
n=21 Participants
|
|
Number of times pregnant
5 pregnancies
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Number of times pregnant
6 pregnancies
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Number of times pregnant
7 pregnancies
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Number of times pregnant
8 pregnancies
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Number of live births
0 live births
|
49 participants
n=5 Participants
|
44 participants
n=7 Participants
|
42 participants
n=5 Participants
|
47 participants
n=4 Participants
|
182 participants
n=21 Participants
|
|
Number of live births
1 live birth
|
14 participants
n=5 Participants
|
13 participants
n=7 Participants
|
12 participants
n=5 Participants
|
10 participants
n=4 Participants
|
49 participants
n=21 Participants
|
|
Number of live births
2 live births
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Number of live births
3 live births
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Number of live births
4 live births
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Number of live births
5 live births
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Request for labor analgesia up to the first 30 minutes after the placement of epiduralThe number of participants who experience non-reassuring fetal heart rate tracings obtained via electronic recording during the first 30 minutes after the placement of epidural analgesia
Outcome measures
| Measure |
Group A
n=62 Participants
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
|
Group B
n=59 Participants
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Group C
n=54 Participants
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
|
Group D
n=55 Participants
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Group Sum
Sum of the four groups
|
|---|---|---|---|---|---|
|
Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
Favorable fetal heart rate tracings
|
47 participants
|
54 participants
|
44 participants
|
47 participants
|
—
|
|
Number of Participants With Non-reassuring Fetal Heart Rate Tracings During the First 30 Minutes After the Placement of Epidural Analgesia
Non reassuring fetal heart rate tracings
|
15 participants
|
5 participants
|
10 participants
|
8 participants
|
—
|
POST_HOC outcome
Timeframe: DeliveryType of delivery (vaginal, forceps assisted, cesarean, emergency cesarean section)
Outcome measures
| Measure |
Group A
n=69 Participants
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
|
Group B
n=62 Participants
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Group C
n=60 Participants
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
|
Group D
n=60 Participants
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Group Sum
n=251 Participants
Sum of the four groups
|
|---|---|---|---|---|---|
|
Delivery Type
Normal spontanous vaginal delivery
|
50 participants
|
43 participants
|
44 participants
|
44 participants
|
181 participants
|
|
Delivery Type
Forceps assisted vaginal delivery
|
6 participants
|
8 participants
|
2 participants
|
6 participants
|
22 participants
|
|
Delivery Type
Cesarean delivery
|
13 participants
|
11 participants
|
14 participants
|
10 participants
|
48 participants
|
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
Group C
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=69 participants at risk
An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient is positioned for epidural placement. Oxytocin management continued as per protocol.
Group A: An intravenous bolus of 1000 mL Lactated Ringers initiated when the patient was positioned for epidural placement. Oxytocin management continued as per protocol.
|
Group B
n=62 participants at risk
An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
Group C
n=60 participants at risk
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
Group C: The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. Oxytocin management continued per protocol.
|
Group D
n=60 participants at risk
The maintenance infusion of 125 mL/hr of Lactated Ringers will be given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement was halved and not increased for 60 minutes until after placement.
Group D: The maintenance infusion of 125 mL/hr of Lactated Ringers was given with no additional fluid bolus. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Cesarean Section for Fetal Distress
|
0.00%
0/69 • To time of delivery of baby.
|
0.00%
0/62 • To time of delivery of baby.
|
0.00%
0/60 • To time of delivery of baby.
|
0.00%
0/60 • To time of delivery of baby.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place