Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial
Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial
1 other identifier
interventional
86
0 countries
N/A
Brief Summary
Tramadol for labor analgesia: a low risk placebo controlled randomised control trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2016
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedDecember 23, 2016
December 1, 2016
1.3 years
December 2, 2016
December 22, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
at 2nd hour of administration
Secondary Outcomes (6)
patient satisfaction
at the end of labor( within 12 hours)
fetal distress
during labor
duration of 1st and 2nd stage of labor
1st and 2nd stage
women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness
till the end of labor
neonatal safety in terms of apgar score and nicu admission
apgar score at 0 and 5 min
- +1 more secondary outcomes
Study Arms (2)
tramadol
EXPERIMENTAL50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic
distilled water
PLACEBO COMPARATOR2ml distilled water intramuscularly will be used as a placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- any medical disorder- diabetes,hypertension
- obstetric high risk factors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
dr aastha raheja
Maulana Azad Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- post graduate 1st year student obstetrics and gynecology department
Study Record Dates
First Submitted
December 2, 2016
First Posted
December 21, 2016
Study Start
December 1, 2016
Primary Completion
April 1, 2018
Study Completion
May 1, 2018
Last Updated
December 23, 2016
Record last verified: 2016-12