Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03822052
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Katelyn Hartung, Genesys Regional Medical Center

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.

Condition or disease Intervention/treatment Phase
Induction of Labor Affected Fetus / Newborn Other: Lactated ringers Other: 5% dextrose lactated ringers Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. Time of induction [ Time Frame: 492 min +/- 35 min ]
    Time from start of labor induction to delivery of infant


Secondary Outcome Measures :
  1. Time of Active Labor [ Time Frame: 4 hours +/- 3 hours ]
    time from 6 cm dilation until delivery of infant

  2. Apgar Scores [ Time Frame: 492 min +/- 35 min ]
    validated measure of infant health

  3. Mode of Delivery [ Time Frame: 492 min +/- 35 min ]
    Cesarean section vs SVD vs OVD

  4. Neonatal ICU admissions [ Time Frame: 24 hours after delivery ]
    ICU or special care nursery admissions

  5. Need for respiratory support [ Time Frame: 24 hours after delivery ]
    Neonatal need for respiratory support

  6. Transfer to tertiary care center [ Time Frame: 24 hours after delivery ]
    neonatal need for transfer to higher level NICU



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822052


Contacts
Layout table for location contacts
Contact: Katelyn Hartung, DO 8106065850 katelyn.hartung@ascension.org

Locations
Layout table for location information
United States, Michigan
Ascension Genesys Hospital Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Jennifer McCullough    810-606-7878    jennifer.mccullough@ascension.org   
Principal Investigator: Katelyn Hartung, DO         
Sponsors and Collaborators
Genesys Regional Medical Center

Publications:
Layout table for additonal information
Responsible Party: Katelyn Hartung, DO, Postgraduate Year 3, Genesys Regional Medical Center
ClinicalTrials.gov Identifier: NCT03822052     History of Changes
Other Study ID Numbers: ME 19 004
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs