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Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

Primary Purpose

Tramadol for Labor Analgesia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tramadol Hydrochloride
Distilled Water
Sponsored by
Maulana Azad Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tramadol for Labor Analgesia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • delivering for first time(nulliparous)
  • well established labor ( 3 or more contractions in a span of ten minutes
  • cervical dilation of 4 cm or more
  • >= 80% effacement of cervix

Exclusion Criteria:

  • any medical disorder- diabetes,hypertension
  • obstetric high risk factors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    tramadol

    distilled water

    Arm Description

    50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic

    2ml distilled water intramuscularly will be used as a placebo.

    Outcomes

    Primary Outcome Measures

    visual analogue scale
    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

    Secondary Outcome Measures

    patient satisfaction
    scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied
    fetal distress
    fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)
    duration of 1st and 2nd stage of labor
    women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness
    increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol
    neonatal safety in terms of apgar score and nicu admission
    need for caesarean section or instrumental delivery
    emergency caesarean section or need for forceps or vacuum application

    Full Information

    First Posted
    December 2, 2016
    Last Updated
    December 22, 2016
    Sponsor
    Maulana Azad Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02999594
    Brief Title
    Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial
    Official Title
    Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    April 2018 (Anticipated)
    Study Completion Date
    May 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Maulana Azad Medical College

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Tramadol for labor analgesia: a low risk placebo controlled randomised control trial
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tramadol for Labor Analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    86 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tramadol
    Arm Type
    Experimental
    Arm Description
    50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic
    Arm Title
    distilled water
    Arm Type
    Placebo Comparator
    Arm Description
    2ml distilled water intramuscularly will be used as a placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    Tramadol Hydrochloride
    Intervention Description
    50mg intramuscularly
    Intervention Type
    Drug
    Intervention Name(s)
    Distilled Water
    Intervention Description
    2ml intramuscularly
    Primary Outcome Measure Information:
    Title
    visual analogue scale
    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
    Time Frame
    at 2nd hour of administration
    Secondary Outcome Measure Information:
    Title
    patient satisfaction
    Description
    scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied
    Time Frame
    at the end of labor( within 12 hours)
    Title
    fetal distress
    Description
    fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)
    Time Frame
    during labor
    Title
    duration of 1st and 2nd stage of labor
    Time Frame
    1st and 2nd stage
    Title
    women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness
    Description
    increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol
    Time Frame
    till the end of labor
    Title
    neonatal safety in terms of apgar score and nicu admission
    Time Frame
    apgar score at 0 and 5 min
    Title
    need for caesarean section or instrumental delivery
    Description
    emergency caesarean section or need for forceps or vacuum application
    Time Frame
    during labor

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: delivering for first time(nulliparous) well established labor ( 3 or more contractions in a span of ten minutes cervical dilation of 4 cm or more >= 80% effacement of cervix Exclusion Criteria: any medical disorder- diabetes,hypertension obstetric high risk factors
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    dr aastha raheja
    Phone
    8586032882
    Email
    aastha_raheja2000@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    dr krishna agarwal
    Phone
    9871214208
    Email
    drkrishna.agarwal@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    dr aastha raheja
    Organizational Affiliation
    Maulana Azad Medical College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

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