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Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial

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ClinicalTrials.gov Identifier: NCT02999594
Recruitment Status : Unknown
Verified December 2016 by dr aastha raheja, Maulana Azad Medical College.
Recruitment status was:  Not yet recruiting
First Posted : December 21, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
dr aastha raheja, Maulana Azad Medical College

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

Condition or disease Intervention/treatment Phase
Tramadol for Labor Analgesia Drug: Tramadol Hydrochloride Drug: Distilled Water Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial
Study Start Date : December 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tramadol
50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic
Drug: Tramadol Hydrochloride
50mg intramuscularly

Placebo Comparator: distilled water
2ml distilled water intramuscularly will be used as a placebo.
Drug: Distilled Water
2ml intramuscularly




Primary Outcome Measures :
  1. visual analogue scale [ Time Frame: at 2nd hour of administration ]
    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 :
  1. patient satisfaction [ Time Frame: at the end of labor( within 12 hours) ]
    scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied

  2. fetal distress [ Time Frame: during labor ]
    fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)

  3. duration of 1st and 2nd stage of labor [ Time Frame: 1st and 2nd stage ]
  4. women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness [ Time Frame: till the end of labor ]
    increased risk of postpartum haemorrhage, nausea , vomiting and sleepiness may be associated with use of tramadol

  5. neonatal safety in terms of apgar score and nicu admission [ Time Frame: apgar score at 0 and 5 min ]
  6. need for caesarean section or instrumental delivery [ Time Frame: during labor ]
    emergency caesarean section or need for forceps or vacuum application



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999594


Contacts
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Contact: dr aastha raheja 8586032882 aastha_raheja2000@yahoo.com
Contact: dr krishna agarwal 9871214208 drkrishna.agarwal@gmail.com

Sponsors and Collaborators
Maulana Azad Medical College
Investigators
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Principal Investigator: dr aastha raheja Maulana Azad Medical College

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Responsible Party: dr aastha raheja, post graduate 1st year student obstetrics and gynecology department, Maulana Azad Medical College
ClinicalTrials.gov Identifier: NCT02999594     History of Changes
Other Study ID Numbers: mamc123
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
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Tramadol
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents