<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/NCT02989571</url>
  </required_header>
  <id_info>
    <org_study_id>628-15</org_study_id>
    <nct_id>NCT02989571</nct_id>
  </id_info>
  <brief_title>The Effects of Increased IV Hydration on Nulliparous Women Undergoing an Induction of Labor</brief_title>
  <official_title>A Double-Blinded Randomized Controlled Trial on the Effects of Increased Intravenous Hydration on Nulliparous Women Undergoing an Induction of Labor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MemorialCare Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MemorialCare Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare the effects of intravenous fluid rate on the course&#xD;
      of labor in nulliparous patients who are undergoing labor induction and have an unfavorable&#xD;
      cervix. The primary hypothesis is that an increased rate of intravenous fluids will shorten&#xD;
      the length of labor in patients undergoing induction with an unfavorable cervix.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise physiology has shown that increased fluid intake and replacement can improve&#xD;
      skeletal muscle performance in prolonged exercise. Labor is a physically demanding process&#xD;
      that is essentially an &quot;exercise&quot; of the uterus, where uterine contractions of varying&#xD;
      strength and dilation lead to thinning and dilation of the cervix and to eventual delivery of&#xD;
      the infant. It has logically been theorized that, as with any exercise, improved hydration&#xD;
      and delivery of carbohydrates to uterine smooth muscle can help optimize the contractions&#xD;
      needed during labor. Conversely, dehydration is believed to result not only in decreased&#xD;
      uterine perfusion (due to decreased intravascular volume), but also in reduced delivery of&#xD;
      nutrients and elimination of waste products from the contracting myometrium.&#xD;
&#xD;
      Inadequate maternal hydration has been postulated to be a contributing factor to prolonged or&#xD;
      dysfunctional labor, in which uterine contractions are not sufficiently strong or are&#xD;
      inappropriately coordinated to cause adequate cervical dilation and effacement. Even in&#xD;
      patients who completely dilate, sufficient voluntary and involuntary muscle effort is&#xD;
      required during the second stage of labor to achieve a vaginal delivery. Prolonged labors can&#xD;
      not only lead to increased hospitalization cost, but also to increased risks of cesarean&#xD;
      delivery for indications such as &quot;failure to progress,&quot; chorioamnionitis (intrauterine&#xD;
      infection), and postpartum hemorrhage. Establishing techniques to optimize the length and&#xD;
      duration of labor has therefore been an area of particular research interest.&#xD;
&#xD;
      To date, several randomized, controlled studies have demonstrated that with higher&#xD;
      intravenous (IV) fluid rates, there is a decreased frequency of prolonged labor and possibly&#xD;
      a decreased need for oxytocin in patients who present in active labor. One of these studies&#xD;
      was performed here at Long Beach Memorial by Garite et al under IRB approval and supervision.&#xD;
      Importantly, a systematic review of these studies by the Cochrane Collaboration in 2013&#xD;
      demonstrated that increased intravenous fluid rates (250mL/hr vs 125mL/hr) appears to shorten&#xD;
      the time to delivery and the cesarean delivery rate in patients who present in active labor.&#xD;
&#xD;
      The rate of induction of labor has increased dramatically in recent years, from 9.5% in 1990&#xD;
      to 22.1% in 2004. Women undergoing an induction of labor (whether elective or medically&#xD;
      indicated) represent a distinct population from those who present in active labor, not only&#xD;
      with regards to their baseline characteristics, but also with regards to their labor course&#xD;
      and maternal and neonatal outcomes. There have been no studies thus far investigating the use&#xD;
      of increased intravenous hydration in patients undergoing induction of labor, as previous&#xD;
      studies have focused on patients who present in active labor. The objective of this study is&#xD;
      therefore to determine the effect of increased intravenous hydration in nulliparous patients&#xD;
      undergoing an induction of labor on length of labor, mode of delivery, and other maternal and&#xD;
      neonatal outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <phase>Early Phase 1</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>
    <intervention_model_description>A power size calculation was performed using previously published institutional data as well as previously reported literature regarding induction of labor in nulliparous women. Baseline duration of labor induction among nulliparous women range from 21-30 hours. In order to obtain 80% power to detect a 20% decrease in the duration of labor at a statistical significance level of 0.05, 73 participants are needed in each group. In order to account for participant withdrawal and enrollment errors, the sample size is increased to 90 per group for a total of 180 participants.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of labor (hours of duration)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidural use (yes or no)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxytocin use (yes or no)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of Delivery (vaginal delivery, operative vaginal delivery, or cesarean)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indication for operative or cesarean delivery (e.g. Nonreassuring fetal tracing, arrest of labor, other)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal infectious or other morbidity (Yes or No)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth weight (numerical value in grams)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal weight at 72 hours of life (numerical value in grams)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NICU admission (Yes or No)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for treatment of jaundice (yes or no)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NICU length of stay (numerical value expressed in days)</measure>
    <time_frame>within the first 7 days (plus or minus 3 days) after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delivery within 24 hours (yes or no)</measure>
    <time_frame>within 24 hours after delivery</time_frame>
    <description>Measured via chart review</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Labor; Forced or Induced, Affecting Fetus or Newborn</condition>
  <arm_group>
    <arm_group_label>Group 1 - Placebo Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intravenous normal saline administered at 125ml/hr</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - Intervention Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intravenous normal saline administered at 250ml/hr</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous normal saline administered at 250ml/hr</intervention_name>
    <description>Intravenous normal saline administered at 250ml/hr</description>
    <arm_group_label>Group 2 - Intervention Arm</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intravenous normal saline administered at 125ml/hr</intervention_name>
    <description>Intravenous normal saline administered at 125ml/hr</description>
    <arm_group_label>Group 1 - Placebo Arm</arm_group_label>
    <other_name>Normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  Singleton gestation&#xD;
&#xD;
          -  Nulliparous&#xD;
&#xD;
          -  Vertex presentation&#xD;
&#xD;
          -  Gestational age ≥ 36 weeks&#xD;
&#xD;
          -  Bishop score ≤ 6&#xD;
&#xD;
          -  undergoing induction of labor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiparous&#xD;
&#xD;
          -  Preeclampsia at admission&#xD;
&#xD;
          -  Gestational or chronic hypertension&#xD;
&#xD;
          -  Non-vertex presentation&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Chorioamnionitis at admission&#xD;
&#xD;
          -  Intrauterine growth restriction (&lt;10th percentile)&#xD;
&#xD;
          -  BMI &gt; 50&#xD;
&#xD;
          -  Presence of uterine scar&#xD;
&#xD;
          -  Participation in any other research protocol involving induction of labor&#xD;
&#xD;
          -  Nonreassuring fetal heart rate tracing at admission&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vineet Shrivastava, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Magella Medical Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Long Beach Memorial Medical Center</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>MemorialCare Health System</investigator_affiliation>
    <investigator_full_name>Vineet Shrivastava</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02989571
org study id: 628-15
nct id: NCT02989571
lead sponsor: 
has dmc: No
The objective of this study is to compare the effects of intravenous fluid rate on the course
      of labor in nulliparous patients who are undergoing labor induction and have an unfavorable
      cervix. The primary hypothesis is that an increased rate of intravenous fluids will shorten
      the length of labor in patients undergoing induction with an unfavorable cervix.
Exercise physiology has shown that increased fluid intake and replacement can improve
      skeletal muscle performance in prolonged exercise. Labor is a physically demanding process
      that is essentially an "exercise" of the uterus, where uterine contractions of varying
      strength and dilation lead to thinning and dilation of the cervix and to eventual delivery of
      the infant. It has logically been theorized that, as with any exercise, improved hydration
      and delivery of carbohydrates to uterine smooth muscle can help optimize the contractions
      needed during labor. Conversely, dehydration is believed to result not only in decreased
      uterine perfusion (due to decreased intravascular volume), but also in reduced delivery of
      nutrients and elimination of waste products from the contracting myometrium.

      Inadequate maternal hydration has been postulated to be a contributing factor to prolonged or
      dysfunctional labor, in which uterine contractions are not sufficiently strong or are
      inappropriately coordinated to cause adequate cervical dilation and effacement. Even in
      patients who completely dilate, sufficient voluntary and involuntary muscle effort is
      required during the second stage of labor to achieve a vaginal delivery. Prolonged labors can
      not only lead to increased hospitalization cost, but also to increased risks of cesarean
      delivery for indications such as "failure to progress," chorioamnionitis (intrauterine
      infection), and postpartum hemorrhage. Establishing techniques to optimize the length and
      duration of labor has therefore been an area of particular research interest.

      To date, several randomized, controlled studies have demonstrated that with higher
      intravenous (IV) fluid rates, there is a decreased frequency of prolonged labor and possibly
      a decreased need for oxytocin in patients who present in active labor. One of these studies
      was performed here at Long Beach Memorial by Garite et al under IRB approval and supervision.
      Importantly, a systematic review of these studies by the Cochrane Collaboration in 2013
      demonstrated that increased intravenous fluid rates (250mL/hr vs 125mL/hr) appears to shorten
      the time to delivery and the cesarean delivery rate in patients who present in active labor.

      The rate of induction of labor has increased dramatically in recent years, from 9.5% in 1990
      to 22.1% in 2004. Women undergoing an induction of labor (whether elective or medically
      indicated) represent a distinct population from those who present in active labor, not only
      with regards to their baseline characteristics, but also with regards to their labor course
      and maternal and neonatal outcomes. There have been no studies thus far investigating the use
      of increased intravenous hydration in patients undergoing induction of labor, as previous
      studies have focused on patients who present in active labor. The objective of this study is
      therefore to determine the effect of increased intravenous hydration in nulliparous patients
      undergoing an induction of labor on length of labor, mode of delivery, and other maternal and
      neonatal outcomes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A power size calculation was performed using previously published institutional data as well as previously reported literature regarding induction of labor in nulliparous women. Baseline duration of labor induction among nulliparous women range from 21-30 hours. In order to obtain 80% power to detect a 20% decrease in the duration of labor at a statistical significance level of 0.05, 73 participants are needed in each group. In order to account for participant withdrawal and enrollment errors, the sample size is increased to 90 per group for a total of 180 participants.
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Length of labor (hours of duration)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Epidural use (yes or no)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Oxytocin use (yes or no)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Mode of Delivery (vaginal delivery, operative vaginal delivery, or cesarean)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Indication for operative or cesarean delivery (e.g. Nonreassuring fetal tracing, arrest of labor, other)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Maternal infectious or other morbidity (Yes or No)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Birth weight (numerical value in grams)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Neonatal weight at 72 hours of life (numerical value in grams)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: NICU admission (Yes or No)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Need for treatment of jaundice (yes or no)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: NICU length of stay (numerical value expressed in days)
time frame: within the first 7 days (plus or minus 3 days) after delivery
description: Measured via chart review
measure: Delivery within 24 hours (yes or no)
time frame: within 24 hours after delivery
description: Measured via chart review
arm group label: Group 1 - Placebo Arm
arm group type: Placebo Comparator
description: Intravenous normal saline administered at 125ml/hr
arm group label: Group 2 - Intervention Arm
arm group type: Active Comparator
description: Intravenous normal saline administered at 250ml/hr
intervention type: Drug
intervention name: Intravenous normal saline administered at 250ml/hr
description: Intravenous normal saline administered at 250ml/hr
arm group label: Group 2 - Intervention Arm
other name: Normal saline
intervention type: Drug
intervention name: Intravenous normal saline administered at 125ml/hr
description: Intravenous normal saline administered at 125ml/hr
arm group label: Group 1 - Placebo Arm
other name: Normal saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vineet Shrivastava, MD
role: Principal Investigator
affiliation: Magella Medical Group
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: MemorialCare Health System
investigator full name: Vineet Shrivastava
investigator title: Principal Investigator
sharing ipd: Undecided