Post Partum HemorrhageNCT04463966
Prevention of Postpartum Haemorrhage
A study testing Tranexamic acid injection in people with Post Partum Hemorrhage, run by Benha University at 1 site in Egypt.
Trial summary
Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2020to May 2021
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women at high risk for postpartum hemorrhage after cesarean section
Who cannot join
- women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.
Trial locations and contacts
1 site in 1 country.
shaimaa ezzat contact
Egypt1 site, 1 recruiting
- Recruiting
Police Hospital
Cairo
Shaimaa ezzat, 00201009023289
About this study
Official title: Tranexamic Acid for the Prevention of Postpartum Haemorrhage
Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial
Read the detailed description
This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage \& reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. \& reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Tranexamic acid injection
- Keywords
- tranexamic acid, postpartum hemorrhage, cesarean section
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Also called Kapron, 500 mg/5ml
1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
| Study group | Role | What they receive |
|---|---|---|
| Study | Active comparator | Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) . Receives: Drug: Tranexamic acid injection |
| Control | No intervention | control group will not be given tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Estimation of blood loss
Measured: immediately after deliver
Secondary outcomes (3)
blood pressure
blood pressure
Measured: immediately after delivery
pulse
pulse
Measured: immediately after delivery
temperature
temperature
Measured: immeditely after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start30 Apr 2020
- Primary completionApr 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Benha 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Abou Bakr Mohamed El Nashaar, Benha University
- Investigators
- Shaimaa Ezzat, Principal investigator, Police Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463966
- Sponsor's protocol ID
- Tranexamic
- Status last verified
- Jul 2020
- First submitted
- 30 Apr 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for the Prevention of Postpartum Haemorrhage
- ClinicalTrials.gov ID
- NCT04463966
- Acronym / sponsor ID
- Tranexamic
- Conditions
- Post Partum Hemorrhage
- Keywords
- tranexamic acid, postpartum hemorrhage, cesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 9 Jul 2020 (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.
Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial
Detailed description
This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage \& reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. \& reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | Active comparator | Drug: Tranexamic acid injectionTranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) . |
| Control | No intervention | –control group will not be given tranexamic acid |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women at high risk for postpartum hemorrhage after cesarean section
Key exclusion criteria (1 listed)
- women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.
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 acid injectionAlso: Kapron, 500 mg/5ml1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) . | Drug | Study |
Primary outcome
blood loss
Time frame: immediately after deliver
Estimation of blood loss
3 secondary outcomes
blood pressure
Time frame: immediately after delivery
pulse
Time frame: immediately after delivery
temperature
Time frame: immeditely after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Post Partum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
shaimaa ezzat contact
Shaimaa Ezzat principal investigator
Police Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid injection in people with Post Partum Hemorrhage, run by Benha University 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 1 inclusion and 1 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 9 Jul 2020. 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.
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 Aboubakr Elnashar, MD (00201066934749, elnashar53@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood loss (time frame: immediately after deliver). 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 2020.