Trial Outcomes & Findings for A Trial of Intravenous Fluids During Labor (NCT NCT01110005)
NCT ID: NCT01110005
Last Updated: 2024-01-19
Results Overview
Compare c-section rates between the D5LR and LR treatment groups
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
318 participants
Primary outcome timeframe
From onset of labor to delivery
Results posted on
2024-01-19
Participant Flow
Participant milestones
| Measure |
D5 Lactated Ringers Solution (D5LR)
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
|
Lactated Ringers Solution (LR)
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
161
|
|
Overall Study
COMPLETED
|
153
|
156
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
D5 Lactated Ringers Solution (D5LR)
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
|
Lactated Ringers Solution (LR)
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
|
|---|---|---|
|
Overall Study
ineligible
|
1
|
2
|
|
Overall Study
missing consent
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Trial of Intravenous Fluids During Labor
Baseline characteristics by cohort
| Measure |
D5 Lactated Ringers Solution (D5LR)
n=153 Participants
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
|
Lactated Ringers Solution (LR)
n=156 Participants
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
|
Total
n=309 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.7 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
26.8 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
26.8 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
309 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
129 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From onset of labor to deliveryCompare c-section rates between the D5LR and LR treatment groups
Outcome measures
| Measure |
D5 Lactated Ringers Solution (D5LR)
n=153 Participants
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
|
Lactated Ringers Solution (LR)
n=156 Participants
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
|
|---|---|---|
|
C-Section
|
23 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From onset of labor to deliveryCompare augmentation rates between the D5LR and LR treatment groups
Outcome measures
| Measure |
D5 Lactated Ringers Solution (D5LR)
n=153 Participants
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
|
Lactated Ringers Solution (LR)
n=156 Participants
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
|
|---|---|---|
|
Oxytocin Augmentation
|
92 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: From onset of labor to deliveryCompare time to delivery between the D5LR and LR treatment groups
Outcome measures
| Measure |
D5 Lactated Ringers Solution (D5LR)
n=150 Participants
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
|
Lactated Ringers Solution (LR)
n=150 Participants
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
|
|---|---|---|
|
Time to Delivery
|
12.8 hours
Interval 7.6 to 18.3
|
12.1 hours
Interval 8.4 to 18.0
|
Adverse Events
D5 Lactated Ringers Solution (D5LR)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Lactated Ringers Solution (LR)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
D5 Lactated Ringers Solution (D5LR)
n=153 participants at risk
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
|
Lactated Ringers Solution (LR)
n=156 participants at risk
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
|
|---|---|---|
|
General disorders
Congenital anomalies
|
0.65%
1/153 • Number of events 1 • From onset of labor through the mother's hospital stay
Adverse event information was collected via review of medical charts.
|
3.2%
5/156 • Number of events 5 • From onset of labor through the mother's hospital stay
Adverse event information was collected via review of medical charts.
|
Other adverse events
| Measure |
D5 Lactated Ringers Solution (D5LR)
n=153 participants at risk
IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
|
Lactated Ringers Solution (LR)
n=156 participants at risk
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Postpartum hemorrhage
|
1.3%
2/149 • Number of events 2 • From onset of labor through the mother's hospital stay
Adverse event information was collected via review of medical charts.
|
6.0%
9/151 • Number of events 9 • From onset of labor through the mother's hospital stay
Adverse event information was collected via review of medical charts.
|
Additional Information
Richard S. Legro, M.D.
Milton S. Hershey Medical Center
Phone: 717-531-6210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place