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Currently, the optimum IV fluid for induction of labor is unknown. The goal of this study is to determine the optimum fluid for induction of labor, D5LR versus LR. The investigators hypothesize that patients assigned to the D5LR group will have a shorter induction of labor when compared to patient's in the LR group.
Induction of labor is increasingly common in the United States, as the overall rate has increased from 9.5% in 1990 to 22.1% in 2006 with the goal to stimulate contractions prior to the onset of spontaneous labor. Cesarean delivery rates are also at an all-time high in the U.S., with more than 32% of patients being delivered by Cesarean in 2009. One of the most common indications for Cesarean section is a prolonged labor course. Patient's with a prolonged labor course are also at risk for infections, including chorioamnionitis and endometritis, as well as an increased risk of postpartum hemorrhage. There is a lack of information on ways to help shorten labor to potentially minimize these risks.
The uterus is comprised of skeletal muscle, and labor has been likened to prolonged rigorous exercise. While oral hydration has been endorsed by ACOG for low-risk women in spontaneous labor, solid foods should be avoided. In turn, women with a prolonged induction or labor may benefit from glucose supplementation via IV fluids.
The DEXTRONS study, J. Pare et al., looked at supplementation of D5LR versus normal saline in nulliparous patients who presented for a favorable induction of labor. This study showed a significant reduction in active labor time in the D5LR group versus the normal saline group.
Currently, at Genesys Regional Medical Center, lactated ringers is the preferred IV fluid for patients presenting for induction of labor. This study will randomly assign patients to D5LR versus lactated ringers and examine the length of time from induction to delivery to determine if glucose supplementation has an effect on reducing length of induction in both nulliparous and multiparous patients for either a favorable induction of labor or an induction for post-dates. Secondary outcomes will include Apgar scores, need for special care nursery/NICU admissions, and mode of delivery. The study will begin in January 2019 and continue through July 2019. Patients who presented to labor and delivery and consent to be included in the study will be randomized to each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primiparous Patient, Unfavorable Bishop Score | Active Comparator | Patient to receive D5LR or LR at 125 cc/hr |
|
| Primiparous Patient, Favorable Bishop Score | Active Comparator | Patient to receive D5LR or LR at 125 cc/hr |
|
| Multiparous patient, Unfavorable Bishop Score | Active Comparator | Patient to receive D5LR or LR at 125 cc/hr |
|
| Multiparous patient, Favorable Bishop Score | Active Comparator | Patient to receive D5LR or LR at 125 cc/hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactated ringers | Other | IV fluid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time of induction | Time from start of labor induction to delivery of infant | 492 min +/- 35 min |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Active Labor | time from 6 cm dilation until delivery of infant | 4 hours +/- 3 hours |
| Apgar Scores | validated measure of infant health |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension Genesys Hospital | Grand Blanc | Michigan | 48439 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28322776 | Background | Fong A, Serra AE, Caballero D, Garite TJ, Shrivastava VK. A randomized, double-blinded, controlled trial of the effects of fluid rate and/or presence of dextrose in intravenous fluids on the labor course of nulliparas. Am J Obstet Gynecol. 2017 Aug;217(2):208.e1-208.e7. doi: 10.1016/j.ajog.2017.03.010. Epub 2017 Mar 18. | |
| 22865033 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 10, 2020 | |
| Reset | May 28, 2020 | |
| Release | Jun 2, 2020 |
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| 5% dextrose lactated ringers | Other | IV fluid |
|
| 492 min +/- 35 min |
| Mode of Delivery | Cesarean section vs SVD vs OVD | 492 min +/- 35 min |
| Neonatal ICU admissions | ICU or special care nursery admissions | 24 hours after delivery |
| Need for respiratory support | Neonatal need for respiratory support | 24 hours after delivery |
| Transfer to tertiary care center | neonatal need for transfer to higher level NICU | 24 hours after delivery |
| Sharma C, Kalra J, Bagga R, Kumar P. A randomized controlled trial comparing parenteral normal saline with and without 5% dextrose on the course of labor in nulliparous women. Arch Gynecol Obstet. 2012 Dec;286(6):1425-30. doi: 10.1007/s00404-012-2485-1. Epub 2012 Aug 4. |
| 19623003 | Background | ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available. |
| 28937571 | Background | Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351. |
| 30575678 | Background | ACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006. |
| 30575638 | Background | ACOG Committee Opinion No. 766: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2019 Feb;133(2):e164-e173. doi: 10.1097/AOG.0000000000003074. |
| 3314516 | Background | Philipson EH, Kalhan SC, Riha MM, Pimentel R. Effects of maternal glucose infusion on fetal acid-base status in human pregnancy. Am J Obstet Gynecol. 1987 Oct;157(4 Pt 1):866-73. doi: 10.1016/s0002-9378(87)80075-3. |
| 28153654 | Background | Pare J, Pasquier JC, Lewin A, Fraser W, Bureau YA. Reduction of total labor length through the addition of parenteral dextrose solution in induction of labor in nulliparous: results of DEXTRONS prospective randomized controlled trial. Am J Obstet Gynecol. 2017 May;216(5):508.e1-508.e7. doi: 10.1016/j.ajog.2017.01.010. Epub 2017 Jan 30. |
| Reset | Jun 15, 2020 |
| Release | Jun 23, 2020 |
| Reset | Jul 6, 2020 |
| Release | Dec 10, 2020 |
| Reset | Jan 4, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 10, 2020 | May 28, 2020 | |||
| Jun 2, 2020 | Jun 15, 2020 | |||
| Jun 23, 2020 | Jul 6, 2020 | |||
| Dec 10, 2020 | Jan 4, 2021 |
| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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