Blood Loss, SurgicalNCT05273632
Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)
A study testing Oxytocin in people with Blood Loss, Surgical and Blood Loss, Postoperative, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2022to 30 Sep 2022
- 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
- Pregnant females admitted for Elective Cesarean Section.
- Gestational age of pregnancy (38 weeks To 40 weeks).
- the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
- Singleton living fetus.
- No medical disorders.
- Informed Oral Consent From The Patient.
Who cannot join
- Severe 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, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
- Acute liver or kidney diseases; blood disorders, such as anaemia.
- Allergy to Tranexamic acid.
- Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
- Ante partum Hemorrhage such placental abruption.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Placebo to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.
Read the detailed description
Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.
- Conditions
- Blood Loss, Surgical, Blood Loss, Postoperative
- Being tested
- Oxytocin
- Keywords
- blood loss, cesarean section, oxytocin, tranexamic acid, etamsylate, saline, Intra-operative, Postoperative
- 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.
OxytocinDrug
Also called Tranexamic acid and Etamsylate
trial of reduction of losing blood intra operative or post operative during Cesarean Delivery
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Active comparator | Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision Receives: Drug: Oxytocin |
| Tranexamic acid and Etamsylate | Active comparator | Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery Receives: Drug: Oxytocin |
| Saline | Placebo comparator | Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss during and after cesarean delivery
Measuring of Hemoglobin level and Hematocrit level pre and post operatively.
Measured: First 2 hours after C-Section
Secondary outcomes (1)
post operative bleeding
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 posted10 Mar 2022
- Study start20 Mar 2022
- Primary completion15 Sep 2022
- Study completion30 Sep 2022
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273632
- Sponsor's protocol ID
- EL-SAYED EL-DESOUKY
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Placebo to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT05273632
- Acronym / sponsor ID
- EL-SAYED EL-DESOUKY
- Conditions
- Blood Loss, Surgical, Blood Loss, Postoperative
- Keywords
- blood loss, cesarean section, oxytocin, tranexamic acid, etamsylate, saline, Intra-operative, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 10 Mar 2022 (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.
Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.
Detailed description
Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Active comparator | Drug: OxytocinPre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision |
| Tranexamic acid and Etamsylate | Active comparator | Drug: OxytocinTranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery |
| Saline | Placebo comparator | Drug: OxytocinNormal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant females admitted for Elective Cesarean Section.
- Gestational age of pregnancy (38 weeks To 40 weeks).
- the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
- Singleton living fetus.
- No medical disorders.
Key exclusion criteria (6 listed)
- Severe 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, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
- Acute liver or kidney diseases; blood disorders, such as anaemia.
- Allergy to Tranexamic acid.
- Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
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 |
|---|---|---|
| OxytocinAlso: Tranexamic acid and Etamsylatetrial of reduction of losing blood intra operative or post operative during Cesarean Delivery | Drug | Oxytocin, Saline, Tranexamic acid and Etamsylate |
Primary outcome
blood loss during and after cesarean delivery
Time frame: First 2 hours after C-Section
Measuring of Hemoglobin level and Hematocrit level pre and post operatively.
1 secondary outcome
post operative bleeding
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 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin 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 6 inclusion and 6 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 8 Feb 2023. 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. 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.
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?
blood loss during and after cesarean delivery (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 8 Feb 2023.