HemorrhagePhase 1/2NCT01085006
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery
A Phase 1/2 study testing Tranexamic acid and Normal saline in people with Hemorrhage, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Tranexamic acid and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Term pregnancy
- Single fetus
- Maximally only one previous cesarean delivery
Who cannot join
- More than one previous cesarean delivery
- Hx of other abdominal or pelvic surgery
- Hx of medical disorders
- Hx of thromboembolic disorders
- Polyhydramnios
- Macrosomia
Show all 9Show fewer
- Preeclampsia
- Hx of sensitivity to Tranexamic acid
- Abnormal Pt, PTT, PT or INR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery
Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.
- Conditions
- Hemorrhage
- Being tested
- Tranexamic acid, Normal saline
- Keywords
- cesarean delivery, Tranexamic acid, hemorrhage, Spinal analgesia, 1-the amount of hemorrhage during cesarean delivery, 2-the amount of hemorrhage in the first 2 hours of cesarean delivery, 3-the amount of hemorrhage in the first 24 hour after cesarean delivery
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Tranexamic acid in cases, normal saline in controls
Normal salineDrug
Tranexamic acid in cases, normal saline in controls
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Not described Receives: Drug: Tranexamic acid |
| normal saline infusion | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward
Measured: During the procedure and within 2 hours afterwards
Secondary outcomes (1)
Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemorrhageStudies 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 1/2
- Primary purpose
- Prevention
- 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
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Laleh Eslamian, MD, Principal investigator, Associated Prof, Obstetrician & Gynecologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085006
- Sponsor's protocol ID
- 830
- Status last verified
- Nov 2010
- First submitted
- 10 Mar 2010
- Last updated
- 25 Jan 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tranexamic Acid Administration on Postpartum Hemorrhage During and After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT01085006
- Acronym / sponsor ID
- 830
- Conditions
- Hemorrhage
- Keywords
- cesarean delivery, Tranexamic acid, hemorrhage, Spinal analgesia, 1-the amount of hemorrhage during cesarean delivery, 2-the amount of hemorrhage in the first 2 hours of cesarean delivery, 3-the amount of hemorrhage in the first 24 hour after cesarean delivery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Posted 25 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acid |
| normal saline infusion | Placebo comparator | Drug: Normal saline |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Term pregnancy
- Single fetus
- Maximally only one previous cesarean delivery
Key exclusion criteria (9 listed)
- More than one previous cesarean delivery
- Hx of other abdominal or pelvic surgery
- Hx of medical disorders
- Hx of thromboembolic disorders
- Polyhydramnios
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 |
|---|---|---|
| Tranexamic acidTranexamic acid in cases, normal saline in controls | Drug | Tranexamic acid |
| Normal salineTranexamic acid in cases, normal saline in controls | Drug | normal saline infusion |
Primary outcome
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward
Time frame: During the procedure and within 2 hours afterwards
1 secondary outcome
Amount of Hemorrhage in the First 24 Hour After Cesarean Delivery
Time frame: First 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Laleh Eslamian, MD principal investigator
Associated Prof, Obstetrician & Gynecologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tranexamic acid and Normal saline in people with Hemorrhage, run by Tehran University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 9 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 25 Jan 2011. 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 Iran. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Amount of Hemorrhage During Cesarean Delivery and Within 2 Hours Afterward (time frame: During the procedure and within 2 hours afterwards). 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 25 Jan 2011.