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| Name | Class |
|---|---|
| Lehigh Valley Hospital | OTHER |
| The Reading Hospital and Medical Center | OTHER |
| St. Luke's Hospital, Pennsylvania | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D5 Lactated Ringer's solution (D5LR) | Active Comparator | IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr. |
|
| Lactated Ringer's solution (LR) | Active Comparator | Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D5 Lactated Ringer's Solution (D5LR) | Other | D5LR IV fluid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| C-Section | Compare c-section rates between the D5LR and LR treatment groups | From onset of labor to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Oxytocin Augmentation | Compare augmentation rates between the D5LR and LR treatment groups | From onset of labor to delivery |
| Time to Delivery | Compare time to delivery between the D5LR and LR treatment groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard S Legro, M.D. | The Pennsylvania State University College of Medicine, Hershey, Pennsylvania, United States | Study Director |
| John Smulian, M.D. | Lehigh Valley Hospital, Allentown, Pennsylvania, United States | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lehigh Valley Hospital | Allentown | Pennsylvania | 17901 | United States | ||
| St. Luke Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25758624 | Derived | Dapuzzo-Argiriou LM, Smulian JC, Rochon ML, Galdi L, Kissling JM, Schnatz PF, Gonzalez Rios A, Airoldi J, Carrillo MA, Maines J, Kunselman AR, Repke J, Legro RS. A multi-center randomized trial of two different intravenous fluids during labor. J Matern Fetal Neonatal Med. 2016;29(2):191-6. doi: 10.3109/14767058.2014.998190. Epub 2015 Sep 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | D5 Lactated Ringers Solution (D5LR) | IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr. |
| FG001 | Lactated Ringers Solution (LR) | Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A total of 318 subjects were randomized for the study but nine were excluded from analysis entirely: 3 were deemed ineligible, 5 did not have adequate documentation of informed consent, and 1 subject withdrew consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | D5 Lactated Ringers Solution (D5LR) | IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr. |
| BG001 | Lactated Ringers Solution (LR) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | C-Section | Compare c-section rates between the D5LR and LR treatment groups | Posted | Count of Participants | Participants | From onset of labor to delivery |
|
From onset of labor through the mother's hospital stay
Adverse event information was collected via review of medical charts.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | D5 Lactated Ringers Solution (D5LR) | IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital anomalies | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard S. Legro, M.D. | Milton S. Hershey Medical Center | 717-531-6210 | rsl1@psu.edu |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Lactated Ringer's Solution (LR) |
| Other |
LR IV fluid |
|
| From onset of labor to delivery |
| Bethlehem |
| Pennsylvania |
| 18015 |
| United States |
| The Penn State University | Hershey | Pennsylvania | 17033 | United States |
| The Reading Hospital and Medical Center | Reading | Pennsylvania | 19611 | United States |
| Withdrawal by Subject |
|
Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Oxytocin Augmentation | Compare augmentation rates between the D5LR and LR treatment groups | Posted | Count of Participants | Participants | From onset of labor to delivery |
|
|
|
|
| Secondary | Time to Delivery | Compare time to delivery between the D5LR and LR treatment groups | Posted | Median | Inter-Quartile Range | hours | From onset of labor to delivery |
|
|
|
|
| 0 |
| 153 |
| 1 |
| 153 |
| 2 |
| 153 |
| EG001 | Lactated Ringers Solution (LR) | Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr. | 0 | 156 | 5 | 156 | 9 | 156 |
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