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The Use of D5LR Versus LR for Induction of Labor and Time to Delivery in Multiparous and Primiparous Patient's With Favorable and Unfavorable Bishop's Scores

NCT ID: NCT03822052

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2019-12-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Induction of Labor Affected Fetus / Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Primiparous Patient, Unfavorable Bishop Score

Patient to receive D5LR or LR at 125 cc/hr

Group Type ACTIVE_COMPARATOR

Lactated ringers

Intervention Type OTHER

IV fluid

5% dextrose lactated ringers

Intervention Type OTHER

IV fluid

Primiparous Patient, Favorable Bishop Score

Patient to receive D5LR or LR at 125 cc/hr

Group Type ACTIVE_COMPARATOR

Lactated ringers

Intervention Type OTHER

IV fluid

5% dextrose lactated ringers

Intervention Type OTHER

IV fluid

Multiparous patient, Unfavorable Bishop Score

Patient to receive D5LR or LR at 125 cc/hr

Group Type ACTIVE_COMPARATOR

Lactated ringers

Intervention Type OTHER

IV fluid

5% dextrose lactated ringers

Intervention Type OTHER

IV fluid

Multiparous patient, Favorable Bishop Score

Patient to receive D5LR or LR at 125 cc/hr

Group Type ACTIVE_COMPARATOR

Lactated ringers

Intervention Type OTHER

IV fluid

5% dextrose lactated ringers

Intervention Type OTHER

IV fluid

Interventions

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Lactated ringers

IV fluid

Intervention Type OTHER

5% dextrose lactated ringers

IV fluid

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women, age 18 - 45, that were admitted for induction of labor without any co-morbid conditions and their respective newborns with
* Induction of labor
* Singleton pregnancies
* Vertex presentation
* Pregnancies at 39 0/7 weeks gestation - 41 6/7 weeks gestation
* All races/ethnicities

Exclusion Criteria

* Multifetal gestations
* Noncephalic presentation
* Preexisting medical conditions:
* Maternal cardiac disease
* Lung diseases
* Chronic hypertension
* Pregestational or gestational diabetes
* gHTN or Pre-Eclampsia
* medical indication for induction of labor (olighydramnios, IUGR)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ascension Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Katelyn Hartung

DO, Postgraduate Year 3

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ascension Genesys Hospital

Grand Blanc, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28322776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22865033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19623003 (View on PubMed)

Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 183: Postpartum Hemorrhage. Obstet Gynecol. 2017 Oct;130(4):e168-e186. doi: 10.1097/AOG.0000000000002351.

Reference Type BACKGROUND
PMID: 28937571 (View on PubMed)

ACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006.

Reference Type BACKGROUND
PMID: 30575678 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30575638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3314516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28153654 (View on PubMed)

Other Identifiers

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ME 19 004

Identifier Type: -

Identifier Source: org_study_id