<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/NCT02999594</url>
  </required_header>
  <id_info>
    <org_study_id>mamc123</org_study_id>
    <nct_id>NCT02999594</nct_id>
  </id_info>
  <brief_title>Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial</brief_title>
  <official_title>Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maulana Azad Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maulana Azad Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tramadol for labor analgesia: a low risk placebo controlled randomised control trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators will administer 100mg tramadol or 2ml distilled water through intramuscular&#xD;
      route in a blinded manner. Visual analogue score will be assessed in the beginning and every&#xD;
      hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of&#xD;
      labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum&#xD;
      haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>visual analogue scale</measure>
    <time_frame>at 2nd hour of administration</time_frame>
    <description>visual analogue scale i.e scaling of severity of pain from 1 being mildest and 10 being most severe will be assessed at 2nd hour of administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>at the end of labor( within 12 hours)</time_frame>
    <description>scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fetal distress</measure>
    <time_frame>during labor</time_frame>
    <description>fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>duration of 1st and 2nd stage of labor</measure>
    <time_frame>1st and 2nd stage</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness</measure>
    <time_frame>till the end of labor</time_frame>
    <description>increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neonatal safety in terms of apgar score and nicu admission</measure>
    <time_frame>apgar score at 0 and 5 min</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need for caesarean section or instrumental delivery</measure>
    <time_frame>during labor</time_frame>
    <description>emergency caesarean section or need for forceps or vacuum application</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Tramadol for Labor Analgesia</condition>
  <arm_group>
    <arm_group_label>tramadol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>distilled water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2ml distilled water intramuscularly will be used as a placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tramadol Hydrochloride</intervention_name>
    <description>50mg intramuscularly</description>
    <arm_group_label>tramadol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Distilled Water</intervention_name>
    <description>2ml intramuscularly</description>
    <arm_group_label>distilled water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  delivering for first time(nulliparous)&#xD;
&#xD;
          -  well established labor ( 3 or more contractions in a span of ten minutes&#xD;
&#xD;
          -  cervical dilation of 4 cm or more&#xD;
&#xD;
          -  &gt;= 80% effacement of cervix&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any medical disorder- diabetes,hypertension&#xD;
&#xD;
          -  obstetric high risk factors&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>dr aastha raheja</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maulana Azad Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>dr aastha raheja</last_name>
    <phone>8586032882</phone>
    <email>aastha_raheja2000@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>dr krishna agarwal</last_name>
    <phone>9871214208</phone>
    <email>drkrishna.agarwal@gmail.com</email>
  </overall_contact_backup>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 22, 2016</last_update_submitted>
  <last_update_submitted_qc>December 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maulana Azad Medical College</investigator_affiliation>
    <investigator_full_name>dr aastha raheja</investigator_full_name>
    <investigator_title>post graduate 1st year student obstetrics and gynecology department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Agnosia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tramadol</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>March 23, 2018</submitted>
    <returned>October 24, 2018</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/NCT02999594
org study id: mamc123
nct id: NCT02999594
lead sponsor: 
has dmc: No
Tramadol for labor analgesia: a low risk placebo controlled randomised control trial
Investigators will administer 100mg tramadol or 2ml distilled water through intramuscular
      route in a blinded manner. Visual analogue score will be assessed in the beginning and every
      hour till four hours. patient satisfaction, safety outcomes, duration of 1st and 2nd stage of
      labor, proportion of women experiencing nausea, vomiting and increased sleepiness, postpartum
      haemorrhage,apgar score at 5 minute, need for nicu admission wiil be assessed at the end
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: visual analogue scale
time frame: at 2nd hour of administration
description: visual analogue scale i.e scaling of severity of pain from 1 being mildest and 10 being most severe will be assessed at 2nd hour of administration
measure: patient satisfaction
time frame: at the end of labor( within 12 hours)
description: scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied
measure: fetal distress
time frame: during labor
description: fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)
measure: duration of 1st and 2nd stage of labor
time frame: 1st and 2nd stage
measure: women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness
time frame: till the end of labor
description: increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol
measure: neonatal safety in terms of apgar score and nicu admission
time frame: apgar score at 0 and 5 min
measure: need for caesarean section or instrumental delivery
time frame: during labor
description: emergency caesarean section or need for forceps or vacuum application
arm group label: tramadol
arm group type: Experimental
description: 50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic
arm group label: distilled water
arm group type: Placebo Comparator
description: 2ml distilled water intramuscularly will be used as a placebo.
intervention type: Drug
intervention name: Tramadol Hydrochloride
description: 50mg intramuscularly
arm group label: tramadol
intervention type: Drug
intervention name: Distilled Water
description: 2ml intramuscularly
arm group label: distilled water
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: dr aastha raheja
role: Principal Investigator
affiliation: Maulana Azad Medical College
last name: dr aastha raheja
phone: 8586032882
email: aastha_raheja2000@yahoo.com
last name: dr krishna agarwal
phone: 9871214208
email: drkrishna.agarwal@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Maulana Azad Medical College
investigator full name: dr aastha raheja
investigator title: post graduate 1st year student obstetrics and gynecology department
mesh term: Agnosia
mesh term: Tramadol
submitted: March 23, 2018
returned: October 24, 2018