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

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

A Randomized Controlled Trial Comparing D5LR to LR for Induction of Labor and Time to Delivery in Multiparous and Primiparous Patient's With Favorable and Unfavorable Bishop's Scores

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822052
• Other study ID #: ME 19 004
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: December 19, 2019

Study information

• Verified date: December 2019
• Source: Ascension Genesys Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 19, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Other:
• Lactated ringers
IV fluid
• 5% dextrose lactated ringers
IV fluid

Locations

Country	Name	City	State
United States	Ascension Genesys Hospital	Grand Blanc	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension Genesys Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

ACOG Committee on Practice Bulletins -- Obstetrics. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-97. doi: 10.1097/AOG.0b013e3181b48ef5. Review. — View Citation

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

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. — View Citation

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

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. — View Citation

Paré 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of induction	Time from start of labor induction to delivery of infant	492 min +/- 35 min
Secondary	Time of Active Labor	time from 6 cm dilation until delivery of infant	4 hours +/- 3 hours
Secondary	Apgar Scores	validated measure of infant health	492 min +/- 35 min
Secondary	Mode of Delivery	Cesarean section vs SVD vs OVD	492 min +/- 35 min
Secondary	Neonatal ICU admissions	ICU or special care nursery admissions	24 hours after delivery
Secondary	Need for respiratory support	Neonatal need for respiratory support	24 hours after delivery
Secondary	Transfer to tertiary care center	neonatal need for transfer to higher level NICU	24 hours after delivery