Pain During LabourPhase 3NCT01889979
Tramadol for Labour Analgesia in Low Risk Primiparous Women
A Phase 3 study testing Tramadol in people with Pain During Labour, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pain During Labour
- What is being tested?
- Tramadol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePanama
- Study dates
- Oct 2012to Jun 2013
- Phase
- Phase 3
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age between 37 and 40 6/7 weeks
- Primiparous patient
- Singleton
- 4 to 5 cms of dilation
- Intact membranes or spontaneous rupture of membranes less than 2 hours
- Fetus in a vertex presentation
- Gynecoid pelvis by clinical examination
Who cannot join
- Multiparous
- Multiple pregnancies
- Any pathology
- Induction of labour with prostaglandins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.
Tramadol is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). The purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.
- Conditions
- Pain During Labour
- Being tested
- Tramadol, Placebo
- Keywords
- Pain during labour, Duration of labour, Apgar score, Umbilical cord pH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TramadolDrug
100 mg of Tramadol was applied in the forearm SC (single dose).
PlaceboDrug
2 ml of a sterile solution was applied in the forearm SC (single dose).
| Study group | Role | What they receive |
|---|---|---|
| Tramadol | Experimental | 100 mg of tramadol SC (single dose) = 2 mL Receives: Drug: Tramadol |
| Placebo | Placebo comparator | 2 mL of a sterile solution SC Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during labour
Pain during labour was evaluated using the Visual Analogue Scale during the first six hours after the application of the drug (tramadol or placebo).
Measured: 6 hours
Secondary outcomes (4)
Duration of labour
The duration of labour in minutes (all patients were admitted with 4-5 cms of dilation), comparing both groups.
Measured: 12 hours
Neonatal outcomes
Apgar score at minute one and five and umbilical cord pH were evaluated and compared between both groups.
Measured: 48 hours
Side effects
Maternal respiratory depression, headaches, nausea and dizziness were evaluated in both groups.
Measured: 48 hours
Requirements of oxytocin
Maximum dose of oxytocin (mU/min) required to have regular uterine contractions.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain During LabourStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Principal investigator, Saint Thomas Maternity HospitalRiggie Castillo, MD, Principal investigator, Saint Thomas Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889979
- Sponsor's protocol ID
- MHST2012-09
- Status last verified
- Jul 2013
- First submitted
- 26 Jun 2013
- Last updated
- 9 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tramadol for Labour Analgesia in Low Risk Primiparous Women. Double Blind, Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01889979
- Acronym / sponsor ID
- MHST2012-09
- Conditions
- Pain During Labour
- Keywords
- Pain during labour, Duration of labour, Apgar score, Umbilical cord pH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Jul 2013 (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 is a centrally acting synthetic analgesic used to treat moderate to moderately severe pain. It has been previously evaluated as a method to reduce pain during labour, but there is always some fear related to its effects (neonatal respiratory depression). The purpose of our study was to evaluate the efficacy of subcutaneous tramadol in regards to pain during labour, duration of labour and neonatal outcomes.
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: Tramadol100 mg of tramadol SC (single dose) = 2 mL |
| Placebo | Placebo comparator | Drug: Placebo2 mL of a sterile solution SC |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Gestational age between 37 and 40 6/7 weeks
- Primiparous patient
- Singleton
- 4 to 5 cms of dilation
- Intact membranes or spontaneous rupture of membranes less than 2 hours
Key exclusion criteria (4 listed)
- Multiparous
- Multiple pregnancies
- Any pathology
- Induction of labour with prostaglandins
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 |
|---|---|---|
| Tramadol100 mg of Tramadol was applied in the forearm SC (single dose). | Drug | Tramadol |
| Placebo2 ml of a sterile solution was applied in the forearm SC (single dose). | Drug | Placebo |
Primary outcome
Pain during labour
Time frame: 6 hours
Pain during labour was evaluated using the Visual Analogue Scale during the first six hours after the application of the drug (tramadol or placebo).
4 secondary outcomes
Duration of labour
Time frame: 12 hours
Neonatal outcomes
Time frame: 48 hours
Side effects
Time frame: 48 hours
Requirements of oxytocin
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
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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.
Osvaldo Reyes, MD principal investigator
Saint Thomas Maternity Hospital
Riggie Castillo, MD principal investigator
Saint Thomas Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tramadol in people with Pain During Labour, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during labour (time frame: 6 hours). 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 9 Jul 2013.