Blood Loss, SurgicalPhase 1/2NCT04656067
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate
A Phase 1/2 study testing Oxytocin ,Tranexamic acid and Ethamsylate in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate, Pre-operative Administration. 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
- Blood Loss, Surgical, Blood Loss, Postoperative
- What is being tested?
- Oxytocin ,Tranexamic acid and Ethamsylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 10 Nov 2020
- Phase
- Phase 1/2
- 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
- Pregnant females admitted for elective Cesarean Section.
- Gestational age (38 to 41 weeks).
- Age of the participants: 20 to 40 years.
- Body Mass Index (18.5 - 29.9).
- Singleton living fetus.
- No medical disorders.
- Informed written consent from the candidates.
Who cannot join
- - Medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid-stimulating hormone(TSH), all of them should be within normal limits).
- -Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
- -Acute and chronic liver or kidney diseases; blood disorders, such as anemia.
- -Allergy to Tranexamic acid or any drug used.
- -Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage.
- - Abnormal placentae such as placenta previa and placental abruption.
- -Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion.
- - Patients who refused spinal anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate, Pre-operative Administration.
Read the detailed description
Caesarean Delivery commonly referred to as caesarean section and occasionally caesarean birth is defined as the delivery of a foetus(es) through surgical incisions made through the anterior abdominal wall (technically referred to as laparotomy) and the anterior uterine wall (technically denoted to as hysterotomy).
Obstetric Hemorrhage (Intra operative OR post operative bleeding)is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. And accounts for 50% of maternal mortality in low-income countries.
So many Strategies reducing the intraoperative blood loss or post operative blood loss could be helpful in decreasing the risks of blood transfusion and the postoperative maternal morbidity.
So these Medications are such as Oxytocin, Carbetocin, Misoprostol, Prostaglandin F2 alpha, methylergonovine, Tranexamic acid and Etamsylate . have been tried before to control bleeding during and after Cesarean Section.
- Conditions
- Blood Loss, Surgical, Blood Loss, Postoperative
- Being tested
- Oxytocin ,Tranexamic acid and Ethamsylate
- Keywords
- blood loss, Cesarean Section, Oxytocin, Tranexamic acid(Kapron), Etamsylate(Dicynon).
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin ,Tranexamic acid and EthamsylateDrug
Also called Syntocinon , Kapron, Dicynon
Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin(only) | Active comparator | oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section Receives: Drug: Oxytocin ,Tranexamic acid and Ethamsylate |
| Tranexamic acid and Ethamsylate | Active comparator | Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section Receives: Drug: Oxytocin ,Tranexamic acid and Ethamsylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.
Measured: First 2 hours after C-Section
Secondary outcomes (1)
Sever PPH as bleeding is >1000 cc
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.
Measured: first 24 hours after C-Section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Apr 2020
- Primary completion1 Oct 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, DR.ABDELAZIM, Egymedicalpedia
- Investigators
- Dr.,AbdelSattar M Farhan, Professor, Principal investigator, Al-Azhar University, Faculty of medicine for boysDr.,ElSayed A. ElDesouky, Professor, Principal investigator, Al-Azhar University, Faculty of medicine for boys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04656067
- Sponsor's protocol ID
- DR,ABDELAZIM SOBHI
- Status last verified
- Feb 2021
- First submitted
- 26 Nov 2020
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Etamsylate .
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT04656067
- Acronym / sponsor ID
- DR,ABDELAZIM SOBHI
- Conditions
- Blood Loss, Surgical, Blood Loss, Postoperative
- Keywords
- blood loss, Cesarean Section, Oxytocin, Tranexamic acid(Kapron), Etamsylate(Dicynon).
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 7 Dec 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.
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate, Pre-operative Administration.
Detailed description
Caesarean Delivery commonly referred to as caesarean section and occasionally caesarean birth is defined as the delivery of a foetus(es) through surgical incisions made through the anterior abdominal wall (technically referred to as laparotomy) and the anterior uterine wall (technically denoted to as hysterotomy).
Obstetric Hemorrhage (Intra operative OR post operative bleeding)is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. And accounts for 50% of maternal mortality in low-income countries.
So many Strategies reducing the intraoperative blood loss or post operative blood loss could be helpful in decreasing the risks of blood transfusion and the postoperative maternal morbidity.
So these Medications are such as Oxytocin, Carbetocin, Misoprostol, Prostaglandin F2 alpha, methylergonovine, Tranexamic acid and Etamsylate . have been tried before to control bleeding during and after Cesarean Section.
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 |
|---|---|---|
| Oxytocin(only) | Active comparator | Drug: Oxytocin ,Tranexamic acid and Ethamsylateoxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section |
| Tranexamic acid and Ethamsylate | Active comparator | Drug: Oxytocin ,Tranexamic acid and EthamsylateTranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Pregnant females admitted for elective Cesarean Section.
- Gestational age (38 to 41 weeks).
- Age of the participants: 20 to 40 years.
- Body Mass Index (18.5 - 29.9).
- Singleton living fetus.
Key exclusion criteria (8 listed)
- - Medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid-stimulating hormone(TSH), all of them should be within normal limits).
- -Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
- -Acute and chronic liver or kidney diseases; blood disorders, such as anemia.
- -Allergy to Tranexamic acid or any drug used.
- -Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage.
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 |
|---|---|---|
| Oxytocin ,Tranexamic acid and EthamsylateAlso: Syntocinon , Kapron, DicynonIs to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate | Drug | Oxytocin(only), Tranexamic acid and Ethamsylate |
Primary outcome
Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)
Time frame: First 2 hours after C-Section
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.
1 secondary outcome
Sever PPH as bleeding is >1000 cc
Time frame: first 24 hours after C-Section
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 17 Mar 2022.
- Individual participant dataSharing planned: Undecided. Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Etamsylate .
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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.
Dr.,AbdelSattar M Farhan, Professor principal investigator
Al-Azhar University, Faculty of medicine for boys
Dr.,ElSayed A. ElDesouky, Professor principal investigator
Al-Azhar University, Faculty of medicine for boys
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 Oxytocin ,Tranexamic acid and Ethamsylate in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by Egymedicalpedia 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 7 inclusion and 8 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 17 Mar 2022. 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 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?
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?
Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc) (time frame: First 2 hours after C-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 17 Mar 2022.