Ketosis
Conditions
Keywords
D5LR, glucose containing IV solution, LR, non glucose IV solution
Brief summary
The purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.
Detailed description
This will be a multi-center, prospective, single-blind randomized trial of two types of IV fluids for maintenance hydration during labor. This study will be conducted at 4 sites: Reading (Reading Hospital), Allentown (Lehigh Valley), St. Luke Hospital and Hershey (Penn State College of Medicine). It will include 1524 pregnant women at ≥ 36 weeks presenting in spontaneous labor for anticipated delivery. The primary research hypothesis is that intravenous hydration during labor with a glucose-containing fluid will lead to more efficient uterine contractility and will lead to a reduction of cesarean delivery. The primary outcome measure is the occurrence of a cesarean birth during the study period. The primary analysis will use an intent-to-treat approach to examine differences between the two IV fluid treatments in the proportion of deliveries requiring cesarean section.
Interventions
OTHERD5 Lactated Ringer's Solution (D5LR)
D5LR IV fluid
OTHERLactated Ringer's Solution (LR)
LR IV fluid
Sponsors
Lehigh Valley Hospital
The Reading Hospital and Medical Center
St. Luke's Hospital, Pennsylvania
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
1. Women of any age with a singleton gestation in spontaneous labor at greater than or equal to 36 weeks without contraindication to participation. 2. These women will be in good health and candidates for vaginal delivery.
Exclusion criteria
1. Patients who are not candidates for vaginal delivery. This may be due to fetal malpresentation, prior cesarean section, multiple gestations, etc. 2. Patients presenting for induction of labor or requiring induction upon admission. 3. Patients presenting for scheduled cesarean section. 4. Patients with any form of diabetes or glucose dysregulation condition. 5. Concurrent use of steroids. 6. Patients presenting in active labor with advanced cervical dilation (≥ 6 cm). 7. Subjects participating in another labor and delivery related clinical trial that conflicts with this trial (as determined by the site PI).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-Section | From onset of labor to delivery | Compare c-section rates between the D5LR and LR treatment groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxytocin Augmentation | From onset of labor to delivery | Compare augmentation rates between the D5LR and LR treatment groups |
| Time to Delivery | From onset of labor to delivery | Compare time to delivery between the D5LR and LR treatment groups |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| D5 Lactated Ringers Solution (D5LR) IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr. | 153 |
| Lactated Ringers Solution (LR) Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr. | 156 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | ineligible | 1 | 2 |
| Overall Study | missing consent | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | D5 Lactated Ringers Solution (D5LR) | Lactated Ringers Solution (LR) | Total |
|---|---|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 4.9 | 26.8 years STANDARD_DEVIATION 4.9 | 26.8 years STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 12 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 144 Participants | 275 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized African American | 4 Participants | 11 Participants | 15 Participants |
| Race/Ethnicity, Customized Caucasian | 129 Participants | 127 Participants | 256 Participants |
| Race/Ethnicity, Customized Other | 18 Participants | 18 Participants | 36 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 153 Participants | 156 Participants | 309 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 153 | 0 / 156 |
| other Total, other adverse events | 2 / 153 | 9 / 156 |
| serious Total, serious adverse events | 1 / 153 | 5 / 156 |
Outcome results
Primary
C-Section
Compare c-section rates between the D5LR and LR treatment groups
Time frame: From onset of labor to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D5 Lactated Ringers Solution (D5LR) | C-Section | 23 Participants |
| Lactated Ringers Solution (LR) | C-Section | 18 Participants |
p-value: 0.3495% CI: [0.7, 2.3]Regression, log binomial
Secondary
Oxytocin Augmentation
Compare augmentation rates between the D5LR and LR treatment groups
Time frame: From onset of labor to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D5 Lactated Ringers Solution (D5LR) | Oxytocin Augmentation | 92 Participants |
| Lactated Ringers Solution (LR) | Oxytocin Augmentation | 88 Participants |
p-value: 0.495% CI: [0.9, 1.3]Regression, log binomial
Secondary
Time to Delivery
Compare time to delivery between the D5LR and LR treatment groups
Time frame: From onset of labor to delivery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| D5 Lactated Ringers Solution (D5LR) | Time to Delivery | 12.8 hours |
| Lactated Ringers Solution (LR) | Time to Delivery | 12.1 hours |
p-value: 0.69Cochran-Mantel-Haenszel