<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/NCT04492150</url>
  </required_header>
  <id_info>
    <org_study_id>4018</org_study_id>
    <nct_id>NCT04492150</nct_id>
  </id_info>
  <brief_title>Effect of Glucose 5% on Labor Length</brief_title>
  <official_title>The Effect of Adding Parenteral Dextrose Solution During Induction of Labor on Total Labor Length Among Multiparous Women in Ismailia, Egypt: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suez Canal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suez Canal University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Induction of labor, is one of the most common obstetric procedures done routinely in modern&#xD;
      obstetrics. For example, in USA, 23% of pregnant women in 2012 (about 1 million) underwent an&#xD;
      induction of labor. However, accurate data about percentage of women undergoing induction of&#xD;
      labor in Egypt is not accurately known.&#xD;
&#xD;
      One of the recent research era in current obstetrics is the optimal intravenous (IV)&#xD;
      hydration of the pregnant women in labor.Current evidences available in our hands, suggest&#xD;
      that maternal hydration appears to fasten labor progress and enhance the action of oxytocin,&#xD;
      if the later is used for augmentation. However, the addition of glucose supplementation to&#xD;
      this IV hydration to enhance uterine contraction, as a matter of safety and efficacy, is&#xD;
      controversial&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 9, 2019</start_date>
  <completion_date type="Anticipated">October 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 10, 2020</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>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the duration of labor</measure>
    <time_frame>24 hours</time_frame>
    <description>the duration from the beginning of active labor (cervical exam between 3 and 5 cm with regular uterine contractions) to fetal delivery, reported in minutes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of cesarean sections</measure>
    <time_frame>24 hours</time_frame>
    <description>the number of cases delivered by cesarean section</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">476</enrollment>
  <condition>Induction of Labor Affected Fetus / Newborn</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>women who will receive 250 mL/hour of normal saline for the whole duration of induction</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dextrose 5%/Nacl 0.3% Inj_#3</intervention_name>
    <description>250 mL/hour of dextrose 5% intravenous drip</description>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>250 mL/hour of normal saline intravenous drip</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (&gt;18 years) multiparous women&#xD;
&#xD;
          -  Late Term Pregnancy ( gestational Age Between 40-42 weeks)&#xD;
&#xD;
          -  Uncomplicated singleton pregnancy with cephalic presentation.&#xD;
&#xD;
          -  Favorable cervix for induction (Bishop score&lt;6) without ruptured membranes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with chronic diseases or complicated pregnancy; gestational and pre gestational&#xD;
             ( type 1 &amp; 2)diabetes, preeclampsia and\or renal and\or maternal heart diseases.&#xD;
&#xD;
          -  Non-cephalic presentations, multiple pregnancies, or cervix unfavorable for induction.&#xD;
&#xD;
          -  Other indications for cesarean delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zakia M Ibraheim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Gynecology and Obstetrics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mariam L Mohammed, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor of Gynecology and Obstetrics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanan M Ghoneim, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor of Gynecology and Obstetrics</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed M Abbas, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor of Gynecology and Obstetrics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Salwa H Tammam, M. B. B. Ch</last_name>
    <phone>00201012869258</phone>
    <email>Dr.salwa.hussein.tammam@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Suez canal University</name>
      <address>
        <city>Ismailia</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Salwa Hussein, MMBCh</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Suez Canal University</investigator_affiliation>
    <investigator_full_name>Salwa Hussein Ismaeil Tammam</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04492150
org study id: 4018
nct id: NCT04492150
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Induction of labor, is one of the most common obstetric procedures done routinely in modern
      obstetrics. For example, in USA, 23% of pregnant women in 2012 (about 1 million) underwent an
      induction of labor. However, accurate data about percentage of women undergoing induction of
      labor in Egypt is not accurately known.

      One of the recent research era in current obstetrics is the optimal intravenous (IV)
      hydration of the pregnant women in labor.Current evidences available in our hands, suggest
      that maternal hydration appears to fasten labor progress and enhance the action of oxytocin,
      if the later is used for augmentation. However, the addition of glucose supplementation to
      this IV hydration to enhance uterine contraction, as a matter of safety and efficacy, is
      controversial
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Investigator)
measure: the duration of labor
time frame: 24 hours
description: the duration from the beginning of active labor (cervical exam between 3 and 5 cm with regular uterine contractions) to fetal delivery, reported in minutes.
measure: Rate of cesarean sections
time frame: 24 hours
description: the number of cases delivered by cesarean section
arm group label: study group
arm group type: Experimental
description: women who will receive 250 mL/hour of dextrose 5% with normal saline in a 1:1 ratio.
arm group label: control group
arm group type: Active Comparator
description: women who will receive 250 mL/hour of normal saline for the whole duration of induction
intervention type: Drug
intervention name: Dextrose 5%/Nacl 0.3% Inj_#3
description: 250 mL/hour of dextrose 5% intravenous drip
arm group label: study group
intervention type: Drug
intervention name: Saline
description: 250 mL/hour of normal saline intravenous drip
arm group label: control group
arm group label: study group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Zakia M Ibraheim, MD
role: Study Chair
affiliation: Professor of Gynecology and Obstetrics
last name: Mariam L Mohammed, MD
role: Study Director
affiliation: Assistant Professor of Gynecology and Obstetrics
last name: Hanan M Ghoneim, MD
role: Study Director
affiliation: Assistant Professor of Gynecology and Obstetrics
last name: Ahmed M Abbas, MD
role: Study Director
affiliation: Assistant Professor of Gynecology and Obstetrics
last name: Salwa H Tammam, M. B. B. Ch
phone: 00201012869258
email: Dr.salwa.hussein.tammam@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Suez Canal University
investigator full name: Salwa Hussein Ismaeil Tammam
investigator title: principal investigator
sharing ipd: No