Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial
NCT ID: NCT02999594
Last Updated: 2016-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
86 participants
INTERVENTIONAL
2016-12-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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tramadol
50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic
Tramadol Hydrochloride
50mg intramuscularly
distilled water
2ml distilled water intramuscularly will be used as a placebo.
Distilled Water
2ml intramuscularly
Interventions
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Tramadol Hydrochloride
50mg intramuscularly
Distilled Water
2ml intramuscularly
Eligibility Criteria
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Inclusion Criteria
* 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
* obstetric high risk factors
FEMALE
Yes
Sponsors
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Maulana Azad Medical College
OTHER
Responsible Party
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dr aastha raheja
post graduate 1st year student obstetrics and gynecology department
Principal Investigators
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dr aastha raheja
Role: PRINCIPAL_INVESTIGATOR
Maulana Azad Medical College
Central Contacts
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Other Identifiers
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mamc123
Identifier Type: -
Identifier Source: org_study_id