BleedingPhase 4NCT02279186
Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section
A Phase 4 study testing Tranexamic Acid in people with Bleeding, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bleeding
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2014to Sep 2015
- Phase
- Phase 4
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- - Women undergoing caesarean delivery for various elective indications.
- Full term primiparas / multiparas.
- Singleton pregnancy being delivered by LSCS.
Who cannot join
- - Medical problems involving the heart, liver, kidney and brain .
- Blood disorders.
- Allergy to tranexamic acid.
- History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
- Multiple pregnancy, macrosomia.
- Polyhydromnios .
- Patients requiring blood transfusion due to anemia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity Hospital
Cairo, 02
Nashwa AlSaied, M.D, 01005369353 ext. 202
Amr Abdelaziz, M.D, 01001783383 ext. 202, dr_AmrAziz@hotmail.com
About this study
Official title: Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial .
In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.
Read the detailed description
To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.
- Conditions
- Bleeding
- Being tested
- Tranexamic Acid
- 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
Also called in 200 ml saline
Intravenous Injection
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | receiving tranexamic acid Receives: Drug: Tranexamic Acid |
| group B | No intervention | does not receive tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss during cesarean section after placental delivery till end of the operation.
Measured: during and 2hours post cesarean section
Secondary outcomes (3)
1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .
composite
Measured: up to 24hours postoperative
Adverse affect of tranexamic acid on mother and neonate .
eg:drug allergy ,drug interaction ,thrombotic manifestation and the number of participant .
Measured: first 24 hours
24 hours post operative haemoglobin and haematocrit .
composite
Measured: after 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mostafa Abdellah Mostafa, Ain Shams Maternity Hospital
- Investigators
- Amr Abdelaziz, M.D, Principal investigator, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279186
- Sponsor's protocol ID
- septemper 2014
- Status last verified
- Nov 2014
- First submitted
- 24 Oct 2014
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intravenous Tranexamic Acid in Reducing Blood Loss During and After Cesarean Section ,A Randomized Clinical Trial .
- ClinicalTrials.gov ID
- NCT02279186
- Acronym / sponsor ID
- septemper 2014
- Conditions
- Bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 30 Oct 2014 (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.
In this study, the efficacy and safety of tranexamic acid in the reducing the blood loss during and after elective LSCS will be investigated.
Detailed description
To state the effectiveness clinically and laboratory and safety of tranexamic acid in reducing blood loss during and after the elective lower segment cesarean section.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Tranexamic Acidreceiving tranexamic acid |
| group B | No intervention | –does not receive tranexamic acid |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Women undergoing caesarean delivery for various elective indications.
- Full term primiparas / multiparas.
- Singleton pregnancy being delivered by LSCS.
Key exclusion criteria (7 listed)
- - Medical problems involving the heart, liver, kidney and brain .
- Blood disorders.
- Allergy to tranexamic acid.
- History of thromboembolic disorders, abnormal placentation, severe pre-eclampsia, uterine anomalies and pathology.
- Multiple pregnancy, macrosomia.
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 AcidAlso: in 200 ml salineIntravenous Injection | Drug | group A |
Primary outcome
Amount of blood loss during cesarean section after placental delivery till end of the operation.
Time frame: during and 2hours post cesarean section
3 secondary outcomes
1.Vital signs eg:blood pressure ,heart rate ,respiratory rate during first two post operative hours .
Time frame: up to 24hours postoperative
Adverse affect of tranexamic acid on mother and neonate .
Time frame: first 24 hours
24 hours post operative haemoglobin and haematocrit .
Time frame: after 24 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
Related trials for Bleeding
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Amr Abdelaziz, M.D principal investigator
Ain Shams 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 4 study testing Tranexamic Acid in people with Bleeding, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 7 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 4 Nov 2014. 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 Egypt. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mahmoud Shalby, MBBCH (01121117275 ext. 202, dr_mahmoud.mostafa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of blood loss during cesarean section after placental delivery till end of the operation. (time frame: during and 2hours post cesarean section). 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 4 Nov 2014.