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NCT Number: NCT03822052

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ascension Genesys Hospital

Grand Blanc, Michigan, 48439, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

lactated ringers

Other

IV fluid

5% dextrose lactated ringers

Other

IV fluid

Primary outcomes

  1. Time of induction

    Time frame: 492 min +/- 35 min

    Time from start of labor induction to delivery of infant

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ascension Health

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2019
Registry last updated
Dec 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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