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

December 20, 2019 updated by: Katelyn Hartung, Ascension Genesys Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Ascension Genesys Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Primiparous Patient, Unfavorable Bishop Score
Patient to receive D5LR or LR at 125 cc/hr
Other: Lactated ringers
IV fluid
Other: 5% dextrose lactated ringers
IV fluid
Active Comparator: Primiparous Patient, Favorable Bishop Score
Patient to receive D5LR or LR at 125 cc/hr
Other: Lactated ringers
IV fluid
Other: 5% dextrose lactated ringers
IV fluid
Active Comparator: Multiparous patient, Unfavorable Bishop Score
Patient to receive D5LR or LR at 125 cc/hr
Other: Lactated ringers
IV fluid
Other: 5% dextrose lactated ringers
IV fluid
Active Comparator: Multiparous patient, Favorable Bishop Score
Patient to receive D5LR or LR at 125 cc/hr
Other: Lactated ringers
IV fluid
Other: 5% dextrose lactated ringers
IV fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of induction
Time Frame: 492 min +/- 35 min
Time from start of labor induction to delivery of infant
492 min +/- 35 min

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascension Genesys Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

November 15, 2019

Study Completion (Actual)

December 19, 2019

Study Registration Dates

First Submitted

January 18, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

December 23, 2019

Last Update Submitted That Met QC Criteria

December 20, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • ME 19 004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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