Placenta PreviaNCT06515535
Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa
A study testing Topical tranexamic acid and Intravenous tranexamic acid in people with Placenta Previa, run by Cairo University.
Trial summary
Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Topical tranexamic acid and Intravenous tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 20-40 years old.
- BMI less than 30 kg/m2.
- Pregnancy of singleton living fetus.
- Placenta previa by ultrasound assessment
- Gestational age > 36 weeks.
Who cannot join
- Women with a history of any medical disorder with pregnancy, e.g., Gestational diabetes and hypertension.
- Women with systemic diseases, e.g., diabetes mellites, systemic immune disorders such as systemic lupus erythematosus
- Women with bleeding tendency or coagulopathy.
- Women on anticoagulants or hemodynamically unstable women.
- Women with uterine abnormalities, such as fibroids or polyps.
- Emergency termination of pregnancy.
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- Intrauterine fetal death.
- Pregnancy with obstetric hemorrhage, e.g., antepartum hemorrhage
- Cases of placenta accrete spectrum disorder or placental abruption
- Women with known allergies to Tranexamic acid
About this study
Official title: Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During Elective Cesarean Delivery in Patients With Placenta Previa
Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa.
Patients will be randomly assigned into two groups:
Read more
Group (A) - Study group (n=28): The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.
Group (B) - Control group (n=28): The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.
- Conditions
- Placenta Previa
- Being tested
- Topical tranexamic acid, Intravenous tranexamic acid
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical tranexamic acidDrug
Topical tranexamic acid will be applied after placental delivery on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%
Intravenous tranexamic acidDrug
Intravenous tranexamic acid will be given in the form of an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.
| Study group | Role | What they receive |
|---|---|---|
| Study group (n=28) | Experimental | The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus. Receives: Drug: Topical tranexamic acid; Drug: Intravenous tranexamic acid |
| Control group (n=28) | Active comparator | The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus. Receives: Drug: Intravenous tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of blood loss
amount of intraoperative blood loss during CS in patients with placenta previa
Measured: during operation
Secondary outcomes (1)
operative time
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start24 Jul 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515535
- Sponsor's protocol ID
- MS-201-2024
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During Elective Cesarean Delivery in Patients With Placenta Previa
- ClinicalTrials.gov ID
- NCT06515535
- Acronym / sponsor ID
- MS-201-2024
- Conditions
- Placenta Previa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jul 2024 (actual)
- 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.
Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa.
Patients will be randomly assigned into two groups:
Group (A) - Study group (n=28): The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.
Group (B) - Control group (n=28): The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (n=28) | Experimental | Drug: Topical tranexamic acid, Drug: Intravenous tranexamic acidThe topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus. |
| Control group (n=28) | Active comparator | Drug: Intravenous tranexamic acidThe intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 20-40 years old.
- BMI less than 30 kg/m2.
- Pregnancy of singleton living fetus.
- Placenta previa by ultrasound assessment
- Gestational age > 36 weeks.
Key exclusion criteria (10 listed)
- Women with a history of any medical disorder with pregnancy, e.g., Gestational diabetes and hypertension.
- Women with systemic diseases, e.g., diabetes mellites, systemic immune disorders such as systemic lupus erythematosus
- Women with bleeding tendency or coagulopathy.
- Women on anticoagulants or hemodynamically unstable women.
- Women with uterine abnormalities, such as fibroids or polyps.
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 |
|---|---|---|
| Topical tranexamic acidTopical tranexamic acid will be applied after placental delivery on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9% | Drug | Study group (n=28) |
| Intravenous tranexamic acidIntravenous tranexamic acid will be given in the form of an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus. | Drug | Control group (n=28), Study group (n=28) |
Primary outcome
Amount of blood loss
Time frame: during operation
amount of intraoperative blood loss during CS in patients with placenta previa
1 secondary outcome
operative time
Time frame: during operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Topical tranexamic acid and Intravenous tranexamic acid in people with Placenta Previa, run by Cairo University.
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 5 inclusion and 10 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 Jul 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
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?
Amount of blood loss (time frame: during operation). 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 Jul 2024.