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

NCT03822052 | Completed

• 1 other identifier: ME 19 004
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Induction of Labor Affected Fetus / Newborn

Outcome Measures

Primary Outcomes (1)

• Time of induction

  Time from start of labor induction to delivery of infant

  492 min +/- 35 min

Secondary Outcomes (6)

• Time of Active Labor

  4 hours +/- 3 hours

• Apgar Scores

  492 min +/- 35 min

• Mode of Delivery

  492 min +/- 35 min

• Neonatal ICU admissions

  24 hours after delivery

• Need for respiratory support

  24 hours after delivery

Study Arms (4)

Primiparous Patient, Unfavorable Bishop Score

ACTIVE COMPARATOR

Patient to receive D5LR or LR at 125 cc/hr

Other: Lactated ringers; Other: 5% dextrose lactated ringers

Primiparous Patient, Favorable Bishop Score

ACTIVE COMPARATOR

Patient to receive D5LR or LR at 125 cc/hr

Other: Lactated ringers; Other: 5% dextrose lactated ringers

Multiparous patient, Unfavorable Bishop Score

ACTIVE COMPARATOR

Patient to receive D5LR or LR at 125 cc/hr

Other: Lactated ringers; Other: 5% dextrose lactated ringers

Multiparous patient, Favorable Bishop Score

ACTIVE COMPARATOR

Patient to receive D5LR or LR at 125 cc/hr

Other: Lactated ringers; Other: 5% dextrose lactated ringers

Interventions

Lactated ringers OTHER

IV fluid

Multiparous patient, Favorable Bishop Score; Multiparous patient, Unfavorable Bishop Score; Primiparous Patient, Favorable Bishop Score; Primiparous Patient, Unfavorable Bishop Score

5% dextrose lactated ringers OTHER

IV fluid

Multiparous patient, Favorable Bishop Score; Multiparous patient, Unfavorable Bishop Score; Primiparous Patient, Favorable Bishop Score; Primiparous Patient, Unfavorable Bishop Score

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ascension Health: lead

Study Sites (1)

Ascension Genesys Hospital

Grand Blanc, Michigan, 48439, United States

Location

Related Publications (8)

• 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.

  PMID: 28322776 BACKGROUND

• 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.

  PMID: 22865033 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.

  PMID: 19623003 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.

  PMID: 28937571 BACKGROUND

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

  PMID: 30575678 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.

  PMID: 30575638 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.

  PMID: 3314516 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.

  PMID: 28153654 BACKGROUND

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DO, Postgraduate Year 3

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 30, 2019
• Study Start: March 15, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 19, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)