Post Operative HemorrhagePhase 3NCT02733952
Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
A Phase 3 study testing Tranexamic Acid and Pericervical Tourniquet in people with Post Operative Hemorrhage, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Post Operative Hemorrhage
- What is being tested?
- Tranexamic Acid and Pericervical Tourniquet
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2015to Aug 2017
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- • Women in the reproductive age (20 - 40 years) diagnosed as having uterine fibroids who are consenting to have trans-abdominal myomectomy in the postmenstrual period diagnosed by:
- Clinical symptoms and signs:
- Abnormal uterine bleeding (menorrhagia or (and) metrorrhagia).
- Pain (dull aching lower abdominal pain or dysmenorrhea).
- Pressure symptoms (dyspareunia, dysuria, dyschezia or (and) backache).
- Progressive abdominal enlargement (abdominal swelling).
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- All women with clinical presentation suggestive of uterine fibroid will undergo abdominal and trans-vaginal ultrasound to confirm the clinical diagnosis and to exclude patients with:
- Submucous uterine myomas.
- Cervical or supracervical myomas.
- Broad ligamentary and pedunculated myomas.
- Associated pelvic pathology.
- Ultrasound criteria of uterine fibroids of included patients:
- Maximum diameter of the largest fibroid is greater than 4cm.
- Maximum number of uterine myomas is not to be more than 5 myomas.
- Uterine fibroid may be subserous or intramural.
Who cannot join
- Obesity (body mass index >30 kg/m2).
- Cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10gm/dl).
- Patients known to be allergic to tranexamic acid.
- Patients who received pre-operative hormonal therapy (such as a GnRH analogue).
- Patients presented by or with suspected malignant gynecological disease.
- Patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids.
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- Patients with contraindication to general anaesthesia.
- Patients with positive pregnancy test.
- Virgin patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university maternity hospital
Cairo, Cairo Governorate, 02002
Mohamad A Ismail, MD, 01200523523 ext. 002, mohamad.abdelhamid@hotmail.com
Ahmed M Bahaaeldein, MD, 01111700556 ext. 002, abahh0503@yahoo.com
About this study
Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
Read the detailed description
this study aims at comparing between different methods to decrease blood loss in trans-abdominal myomectomy. this study compares between medical (intravenous tranexamic acid administration) and non medical (pericervical tourniquet) methods in decreasing blood loss intra operative
- Conditions
- Post Operative Hemorrhage
- Being tested
- Tranexamic Acid, Pericervical Tourniquet
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Kapron
Pericervical TourniquetProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Active comparator | bolus intravenous injection of tranexamic acid 10mg/kg (maximum1g) 15 min before incision followed by continuous infusion of 1mg/kg/h dissolved in 1L of saline for 10 h (maximum
1 g/10 h) Receives: Drug: Tranexamic Acid |
| Pericervical Tourniquet | Active comparator | The tourniquet method will be used where the urinary bladder will be dissected downwards from the lower uterine segment, and then a perforation will be made in the posterior leaflet of the broad ligament bilaterally at the level of uterine isthmus. A tourniquet (using 16- inch Foley catheter) will be passed through the perforation encircling the uterine arteries bilaterally. The Fallopian tubes and the ovaries will be carefully excluded from the line of the tourniquet to avoid direct compression and necrosis. The tourniquet will be released intermittently (at about 30 minutes interval) during the surgery and finally removed after the repair of the uterus Receives: Procedure: Pericervical Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated intra-operative blood loss measured in milliliters
Measured: first 24 hours postoperative
Secondary outcomes (6)
The need for intra-operative blood transfusion
It is indicated when intra-operative blood loss exceeds 15% of the patient's estimated blood volume, which is equal to the patient's weight in kilograms multiplied by 10
Measured: 1 hour
The need for conversion from myomectomy to hysterectomy
It is indicated when there is uncontrolled intra-operative hemorrhage affecting the patient's vital signs and not responsive to conservative measures or when it is impossible to reconstruct the uterus because of the many defects left by the removal of multiple fibroids
Measured: 1 hour
Operative time in minutes
Measured: 1 hour
Intra-operative or post-operative complications
Measured: 24 hours
Difference between Pre and post-operative hemoglobin and hematocrit levels
Postoperative hemoglobin and hematocrit levels are to be measured 24 hours after the operation via a venous blood sample).
Measured: 24 hours
Duration of hospital stay in days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative HemorrhageStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Bahaa Eldin Ahmed, Ain Shams Maternity Hospital
- Investigators
- Ahmad M BahaaEldin, MD, Principal investigator, Ain Shams university maternity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733952
- Sponsor's protocol ID
- ASUObGyn
- Status last verified
- Apr 2016
- First submitted
- 27 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
- ClinicalTrials.gov ID
- NCT02733952
- Acronym / sponsor ID
- ASUObGyn
- Conditions
- Post Operative Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 12 Apr 2016 (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.
Intravenous Tranexamic Acid Versus Pericervical Tourniquet To Decrease Blood Loss In Trans-Abdominal Myomectomy
Detailed description
this study aims at comparing between different methods to decrease blood loss in trans-abdominal myomectomy. this study compares between medical (intravenous tranexamic acid administration) and non medical (pericervical tourniquet) methods in decreasing blood loss intra operative
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Active comparator | Drug: Tranexamic Acidbolus intravenous injection of tranexamic acid 10mg/kg (maximum1g) 15 min before incision followed by continuous infusion of 1mg/kg/h dissolved in 1L of saline for 10 h (maximum 1 g/10 h) |
| Pericervical Tourniquet | Active comparator | Procedure: Pericervical TourniquetThe tourniquet method will be used where the urinary bladder will be dissected downwards from the lower uterine segment, and then a perforation will be made in the posterior leaflet of the broad ligament bilaterally at the level of uterine isthmus. A tourniquet (using 16- inch Foley catheter) will be passed through the perforation encircling the uterine arteries bilaterally. The Fallopian tubes and the ovaries will be carefully excluded from the line of the tourniquet to avoid direct compression and necrosis. The tourniquet will be released intermittently (at about 30 minutes interval) during the surgery and finally removed after the repair of the uterus |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- • Women in the reproductive age (20 - 40 years) diagnosed as having uterine fibroids who are consenting to have trans-abdominal myomectomy in the postmenstrual period diagnosed by:
- Abnormal uterine bleeding (menorrhagia or (and) metrorrhagia).
- Pain (dull aching lower abdominal pain or dysmenorrhea).
- Pressure symptoms (dyspareunia, dysuria, dyschezia or (and) backache).
- Progressive abdominal enlargement (abdominal swelling).
Key exclusion criteria (9 listed)
- Obesity (body mass index >30 kg/m2).
- Cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10gm/dl).
- Patients known to be allergic to tranexamic acid.
- Patients who received pre-operative hormonal therapy (such as a GnRH analogue).
- Patients presented by or with suspected malignant gynecological disease.
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: Kapron | Drug | tranexamic acid |
| Pericervical Tourniquet | Procedure or surgery | Pericervical Tourniquet |
Primary outcome
Estimated intra-operative blood loss measured in milliliters
Time frame: first 24 hours postoperative
6 secondary outcomes
The need for intra-operative blood transfusion
Time frame: 1 hour
The need for conversion from myomectomy to hysterectomy
Time frame: 1 hour
Operative time in minutes
Time frame: 1 hour
Intra-operative or post-operative complications
Time frame: 24 hours
Difference between Pre and post-operative hemoglobin and hematocrit levels
Time frame: 24 hours
Duration of hospital stay in days
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Post Operative Hemorrhage
Not yet recruiting
TEG Use in Children Undergoing Procedures With High Anticipated Blood Loss
Surgical Blood Loss, Surgical Hemorrhage
RecruitingObservational study
Ultrasound for Assessment of Intra-Abdominal Blood Loss After Gynecological Surgery
Post-Operative Hematoma at Operative Site (Diagnosis), Post-Operative 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.
Ahmad M BahaaEldin, MD principal investigator
Ain Shams university 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 3 study testing Tranexamic Acid and Pericervical Tourniquet in people with Post Operative Hemorrhage, 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 15 inclusion and 9 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 12 Apr 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mohamad A Ismail, MD (01200523523 ext. 002, mohamad.abdelhamid@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated intra-operative blood loss measured in milliliters (time frame: first 24 hours postoperative). 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 12 Apr 2016; AzTrials last refreshed its copy on 31 Oct 2026.