<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03822052</url>
  </required_header>
  <id_info>
    <org_study_id>ME 19 004</org_study_id>
    <nct_id>NCT03822052</nct_id>
  </id_info>
  <brief_title>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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascension Genesys Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascension Genesys Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Currently, the optimum IV fluid for induction of labor is unknown. The goal of this study is&#xD;
      to determine the optimum fluid for induction of labor, D5LR versus LR. The investigators&#xD;
      hypothesize that patients assigned to the D5LR group will have a shorter induction of labor&#xD;
      when compared to patient's in the LR group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Induction of labor is increasingly common in the United States, as the overall rate has&#xD;
      increased from 9.5% in 1990 to 22.1% in 2006 with the goal to stimulate contractions prior to&#xD;
      the onset of spontaneous labor. Cesarean delivery rates are also at an all-time high in the&#xD;
      U.S., with more than 32% of patients being delivered by Cesarean in 2009. One of the most&#xD;
      common indications for Cesarean section is a prolonged labor course. Patient's with a&#xD;
      prolonged labor course are also at risk for infections, including chorioamnionitis and&#xD;
      endometritis, as well as an increased risk of postpartum hemorrhage. There is a lack of&#xD;
      information on ways to help shorten labor to potentially minimize these risks.&#xD;
&#xD;
      The uterus is comprised of skeletal muscle, and labor has been likened to prolonged rigorous&#xD;
      exercise. While oral hydration has been endorsed by ACOG for low-risk women in spontaneous&#xD;
      labor, solid foods should be avoided. In turn, women with a prolonged induction or labor may&#xD;
      benefit from glucose supplementation via IV fluids.&#xD;
&#xD;
      The DEXTRONS study, J. Pare et al., looked at supplementation of D5LR versus normal saline in&#xD;
      nulliparous patients who presented for a favorable induction of labor. This study showed a&#xD;
      significant reduction in active labor time in the D5LR group versus the normal saline group.&#xD;
&#xD;
      Currently, at Genesys Regional Medical Center, lactated ringers is the preferred IV fluid for&#xD;
      patients presenting for induction of labor. This study will randomly assign patients to D5LR&#xD;
      versus lactated ringers and examine the length of time from induction to delivery to&#xD;
      determine if glucose supplementation has an effect on reducing length of induction in both&#xD;
      nulliparous and multiparous patients for either a favorable induction of labor or an&#xD;
      induction for post-dates. Secondary outcomes will include Apgar scores, need for special care&#xD;
      nursery/NICU admissions, and mode of delivery. The study will begin in January 2019 and&#xD;
      continue through July 2019. Patients who presented to labor and delivery and consent to be&#xD;
      included in the study will be randomized to each group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2019</start_date>
  <completion_date type="Actual">December 19, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time of induction</measure>
    <time_frame>492 min +/- 35 min</time_frame>
    <description>Time from start of labor induction to delivery of infant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of Active Labor</measure>
    <time_frame>4 hours +/- 3 hours</time_frame>
    <description>time from 6 cm dilation until delivery of infant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar Scores</measure>
    <time_frame>492 min +/- 35 min</time_frame>
    <description>validated measure of infant health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of Delivery</measure>
    <time_frame>492 min +/- 35 min</time_frame>
    <description>Cesarean section vs SVD vs OVD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal ICU admissions</measure>
    <time_frame>24 hours after delivery</time_frame>
    <description>ICU or special care nursery admissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for respiratory support</measure>
    <time_frame>24 hours after delivery</time_frame>
    <description>Neonatal need for respiratory support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer to tertiary care center</measure>
    <time_frame>24 hours after delivery</time_frame>
    <description>neonatal need for transfer to higher level NICU</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Induction of Labor Affected Fetus / Newborn</condition>
  <arm_group>
    <arm_group_label>Primiparous Patient, Unfavorable Bishop Score</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient to receive D5LR or LR at 125 cc/hr</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primiparous Patient, Favorable Bishop Score</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient to receive D5LR or LR at 125 cc/hr</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiparous patient, Unfavorable Bishop Score</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient to receive D5LR or LR at 125 cc/hr</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiparous patient, Favorable Bishop Score</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient to receive D5LR or LR at 125 cc/hr</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lactated ringers</intervention_name>
    <description>IV fluid</description>
    <arm_group_label>Multiparous patient, Favorable Bishop Score</arm_group_label>
    <arm_group_label>Multiparous patient, Unfavorable Bishop Score</arm_group_label>
    <arm_group_label>Primiparous Patient, Favorable Bishop Score</arm_group_label>
    <arm_group_label>Primiparous Patient, Unfavorable Bishop Score</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>5% dextrose lactated ringers</intervention_name>
    <description>IV fluid</description>
    <arm_group_label>Multiparous patient, Favorable Bishop Score</arm_group_label>
    <arm_group_label>Multiparous patient, Unfavorable Bishop Score</arm_group_label>
    <arm_group_label>Primiparous Patient, Favorable Bishop Score</arm_group_label>
    <arm_group_label>Primiparous Patient, Unfavorable Bishop Score</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women, age 18 - 45, that were admitted for induction of labor without any&#xD;
             co-morbid conditions and their respective newborns with&#xD;
&#xD;
          -  Induction of labor&#xD;
&#xD;
          -  Singleton pregnancies&#xD;
&#xD;
          -  Vertex presentation&#xD;
&#xD;
          -  Pregnancies at 39 0/7 weeks gestation - 41 6/7 weeks gestation&#xD;
&#xD;
          -  All races/ethnicities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multifetal gestations&#xD;
&#xD;
          -  Noncephalic presentation&#xD;
&#xD;
          -  Preexisting medical conditions:&#xD;
&#xD;
          -  Maternal cardiac disease&#xD;
&#xD;
          -  Lung diseases&#xD;
&#xD;
          -  Chronic hypertension&#xD;
&#xD;
          -  Pregestational or gestational diabetes&#xD;
&#xD;
          -  gHTN or Pre-Eclampsia&#xD;
&#xD;
          -  medical indication for induction of labor (olighydramnios, IUGR)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ascension Genesys Hospital</name>
      <address>
        <city>Grand Blanc</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>28322776</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>22865033</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19623003</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>28937571</PMID>
  </reference>
  <reference>
    <citation>ACOG Committee Opinion No. 761: Cesarean Delivery on Maternal Request. Obstet Gynecol. 2019 Jan;133(1):e73-e77. doi: 10.1097/AOG.0000000000003006.</citation>
    <PMID>30575678</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>30575638</PMID>
  </reference>
  <reference>
    <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. doi: 10.1016/s0002-9378(87)80075-3.</citation>
    <PMID>3314516</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28153654</PMID>
  </reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ascension Genesys Hospital</investigator_affiliation>
    <investigator_full_name>Katelyn Hartung</investigator_full_name>
    <investigator_title>DO, Postgraduate Year 3</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 10, 2020</submitted>
    <returned>May 28, 2020</returned>
    <submitted>June 2, 2020</submitted>
    <returned>June 15, 2020</returned>
    <submitted>June 23, 2020</submitted>
    <returned>July 6, 2020</returned>
    <submitted>December 10, 2020</submitted>
    <returned>January 4, 2021</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03822052
org study id: ME 19 004
nct id: NCT03822052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Time of induction
time frame: 492 min +/- 35 min
description: Time from start of labor induction to delivery of infant
measure: Time of Active Labor
time frame: 4 hours +/- 3 hours
description: time from 6 cm dilation until delivery of infant
measure: Apgar Scores
time frame: 492 min +/- 35 min
description: validated measure of infant health
measure: Mode of Delivery
time frame: 492 min +/- 35 min
description: Cesarean section vs SVD vs OVD
measure: Neonatal ICU admissions
time frame: 24 hours after delivery
description: ICU or special care nursery admissions
measure: Need for respiratory support
time frame: 24 hours after delivery
description: Neonatal need for respiratory support
measure: Transfer to tertiary care center
time frame: 24 hours after delivery
description: neonatal need for transfer to higher level NICU
arm group label: Primiparous Patient, Unfavorable Bishop Score
arm group type: Active Comparator
description: Patient to receive D5LR or LR at 125 cc/hr
arm group label: Primiparous Patient, Favorable Bishop Score
arm group type: Active Comparator
description: Patient to receive D5LR or LR at 125 cc/hr
arm group label: Multiparous patient, Unfavorable Bishop Score
arm group type: Active Comparator
description: Patient to receive D5LR or LR at 125 cc/hr
arm group label: Multiparous patient, Favorable Bishop Score
arm group type: Active Comparator
description: Patient to receive D5LR or LR at 125 cc/hr
intervention type: Other
intervention name: Lactated ringers
description: IV fluid
arm group label: Multiparous patient, Favorable Bishop Score
arm group label: Multiparous patient, Unfavorable Bishop Score
arm group label: Primiparous Patient, Favorable Bishop Score
arm group label: Primiparous Patient, Unfavorable Bishop Score
intervention type: Other
intervention name: 5% dextrose lactated ringers
description: IV fluid
arm group label: Multiparous patient, Favorable Bishop Score
arm group label: Multiparous patient, Unfavorable Bishop Score
arm group label: Primiparous Patient, Favorable Bishop Score
arm group label: Primiparous Patient, Unfavorable Bishop Score
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
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.
PMID: 28322776
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.
PMID: 22865033
citation: 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
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.
PMID: 28937571
citation: 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
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.
PMID: 30575638
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. doi: 10.1016/s0002-9378(87)80075-3.
PMID: 3314516
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Ascension Genesys Hospital
investigator full name: Katelyn Hartung
investigator title: DO, Postgraduate Year 3
sharing ipd: No
submitted: May 10, 2020
returned: May 28, 2020
submitted: June 2, 2020
returned: June 15, 2020
submitted: June 23, 2020
returned: July 6, 2020
submitted: December 10, 2020
returned: January 4, 2021