Tramadol for Labor AnalgesiaPhase 2NCT02999594
Tramadol for Labor Analgesia: a Placebo Controlled Randomised Control Trial
A Phase 2 study testing Tramadol Hydrochloride and Distilled Water in people with Tramadol for Labor Analgesia, run by Maulana Azad Medical College.
Trial summary
Tramadol for labor analgesia: a low risk placebo controlled randomised control trial Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tramadol for Labor Analgesia
- What is being tested?
- Tramadol Hydrochloride and Distilled Water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any medical disorder- diabetes,hypertension
- obstetric high risk factors
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial
Tramadol for labor analgesia: a low risk placebo controlled randomised control trial
Read the 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
- Conditions
- Tramadol for Labor Analgesia
- Being tested
- Tramadol Hydrochloride, Distilled Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol HydrochlorideDrug
50mg intramuscularly
Distilled WaterDrug
2ml intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| tramadol | Experimental | 50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic Receives: Drug: Tramadol Hydrochloride |
| distilled water | Placebo comparator | 2ml distilled water intramuscularly will be used as a placebo. Receives: Drug: Distilled Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 2nd hour of administration
Secondary outcomes (6)
patient satisfaction
scale of 1-5 including highly satisfied, moderately satisfied ,it is ok ,not satisfied ,highly unsatisfied
Measured: at the end of labor( within 12 hours)
fetal distress
fetal tachycardia (heart rate more than 160) or fetal bradycardia (heart rate less than 100)
Measured: during labor
duration of 1st and 2nd stage of labor
Measured: 1st and 2nd stage
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
Measured: till the end of labor
neonatal safety in terms of apgar score and nicu admission
Measured: apgar score at 0 and 5 min
need for caesarean section or instrumental delivery
emergency caesarean section or need for forceps or vacuum application
Measured: during labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tramadol for Labor AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maulana Azad Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr aastha raheja, Maulana Azad Medical College
- Investigators
- dr aastha raheja, Principal investigator, Maulana Azad Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999594
- Sponsor's protocol ID
- mamc123
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tramadol for Labor Analgesia in Low Risk Women: A Placebo Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT02999594
- Acronym / sponsor ID
- mamc123
- Conditions
- Tramadol for Labor Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Maulana Azad Medical CollegeUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tramadol | Experimental | Drug: Tramadol Hydrochloride50mg tramadol hydrochloride will be used intramuscularly as an experimental drug for evaluating its safety and efficacy as labor analgesic |
| distilled water | Placebo comparator | Drug: Distilled Water2ml distilled water intramuscularly will be used as a placebo. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- any medical disorder- diabetes,hypertension
- obstetric high risk factors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol Hydrochloride50mg intramuscularly | Drug | tramadol |
| Distilled Water2ml intramuscularly | Drug | distilled water |
Primary outcome
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
6 secondary outcomes
patient satisfaction
Time frame: at the end of labor( within 12 hours)
fetal distress
Time frame: during labor
duration of 1st and 2nd stage of labor
Time frame: 1st and 2nd stage
women with side effects like postpartum haemorrhage, nausea, vomiting and increased sleepiness
Time frame: till the end of labor
neonatal safety in terms of apgar score and nicu admission
Time frame: apgar score at 0 and 5 min
need for caesarean section or instrumental delivery
Time frame: during labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
Related trials for Tramadol for Labor Analgesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dr aastha raheja principal investigator
Maulana Azad Medical College
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tramadol Hydrochloride and Distilled Water in people with Tramadol for Labor Analgesia, run by Maulana Azad Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dr aastha raheja (8586032882, aastha_raheja2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: at 2nd hour of administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2016.