MyomaNCT03880045
Topical Tranexamic Acid Plus Perivascular Vasopressin at the Time of Abdominal Myomectomy
A study testing Topical TA and vasopressin in people with Myoma, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Myoma
- What is being tested?
- Topical TA and vasopressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Jun 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
- Age ≥ 18 years and ≤ 50 years
- Pre-operative hemoglobin >8 g/dl
- Ability to understand and the willingness to sign a written informed consent.
- Admissible medical/surgical history
- Five or less symptomatic uterine myomas
- All myomas are subserous or intramural.
- Uterine size less than 24 weeks of pregnancy
Who cannot join
- Patients who have had a prior abdominal myomectomy
- Post-menopausal women
- Patients with known bleeding/clotting disorders
- Patients with a history of gynecologic malignancy
- Hypertension.
- Cardiac and Pulmonary Diseases.
Show all 9Show fewer
- Obesity (body mass index > 30 kg/m2).
- History of allergic reactions attributed to misoprostol
- Cases that will require intraoperative conversion of myomectomy to hysterectomy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān, 81528
Hany F Sallam, MD, 0122336052 ext. 002, hany.farouk@aswu.edu.eg
Nahla W Shady, MD, 01092440504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Topical Tranexamic Acid Plus Perivascular Vasopressin to Decrease Bleeding at the Time of Abdominal Myomectomy: A Double-blinded Randomized Placebo-controlled Trial
In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy
Read the detailed description
Uterine fibroids are the most common female pelvic tumors occurring in about 15% to 30% of women in the reproductive age group. The major problem with myomectomy is excessive bleeding from the increased uterine blood supply. This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy. Knowledge of the effectiveness of the interventions used to reduce blood loss during myomectomy is essential to enable evidence-based clinical decisions. Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration. Studies from cardiac and orthopedic surgery have shown an equal or superior effect of topical compared with intravenous TA on both bleeding and transfusion requirement. Topical treatment is cost-effective, and adverse effects or drug interactions have not been reported
- Conditions
- Myoma
- Being tested
- Topical TA, vasopressin, placebo to TA
- Keywords
- abdominal myomectomy, tranexamic acid, vasopressin
- Medical subject headings
- Myoma, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical TADrug
Also called Active comparator
A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%
vasopressinDrug
Also called Active Comparator
intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy
placebo to TAOther
Also called placebo comparator
(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min.
| Study group | Role | What they receive |
|---|---|---|
| Topical TA plus vasopressin | Active comparator | Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9% Receives: Drug: Topical TA; Drug: vasopressin |
| placebo to TA plus vasopressin | Active comparator | Intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus placebo to tranexamic acid Receives: Drug: vasopressin; Other: placebo to TA |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure will be Mean amount of blood loss
measure will be Mean amount of blood loss by gravimetric methods
Measured: intraoperative
Secondary outcomes (1)
the number of the patients need of blood transfusion
calculate the number of the patients need of blood transfusion
Measured: 24 hours post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Apr 2019
- Primary completion30 Mar 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blinded randomized controlled stud
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f allam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880045
- Sponsor's protocol ID
- aswu/206/19
- Status last verified
- May 2019
- First submitted
- 15 Mar 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Tranexamic Acid Plus Perivascular Vasopressin to Decrease Bleeding at the Time of Abdominal Myomectomy: A Double-blinded Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03880045
- Acronym / sponsor ID
- aswu/206/19
- Conditions
- Myoma
- Keywords
- abdominal myomectomy, tranexamic acid, vasopressin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 19 Mar 2019 (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.
In this study, the investigators will investigate the effectiveness of a topical tranexamic acid plus perivascular vasopressin compared with perivascular vasopressin alone for the reduction of blood loss at the time of myomectomy
Detailed description
Uterine fibroids are the most common female pelvic tumors occurring in about 15% to 30% of women in the reproductive age group. The major problem with myomectomy is excessive bleeding from the increased uterine blood supply. This can be life-threatening, resulting in blood transfusions, febrile morbidity, and potentially in loss of reproductive potential from a hysterectomy. Knowledge of the effectiveness of the interventions used to reduce blood loss during myomectomy is essential to enable evidence-based clinical decisions. Topical application of tranexamic acid(TA) provides a high drug concentration at the site of the wound and a low systemic concentration. Studies from cardiac and orthopedic surgery have shown an equal or superior effect of topical compared with intravenous TA on both bleeding and transfusion requirement. Topical treatment is cost-effective, and adverse effects or drug interactions have not been reported
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blinded randomized controlled stud
| Arm | Type | Receives |
|---|---|---|
| Topical TA plus vasopressin | Active comparator | Drug: Topical TA, Drug: vasopressinIntraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9% |
| placebo to TA plus vasopressin | Active comparator | Drug: vasopressin, Other: placebo to TAIntraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy plus placebo to tranexamic acid |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
- Age ≥ 18 years and ≤ 50 years
- Pre-operative hemoglobin >8 g/dl
- Ability to understand and the willingness to sign a written informed consent.
- Admissible medical/surgical history
Key exclusion criteria (9 listed)
- Patients who have had a prior abdominal myomectomy
- Post-menopausal women
- Patients with known bleeding/clotting disorders
- Patients with a history of gynecologic malignancy
- Hypertension.
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 TAAlso: Active comparatorA gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9% | Drug | Topical TA plus vasopressin |
| vasopressinAlso: Active Comparatorintraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy | Drug | Topical TA plus vasopressin, placebo to TA plus vasopressin |
| placebo to TAAlso: placebo comparator(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min. | Other | placebo to TA plus vasopressin |
Primary outcome
measure will be Mean amount of blood loss
Time frame: intraoperative
measure will be Mean amount of blood loss by gravimetric methods
1 secondary outcome
the number of the patients need of blood transfusion
Time frame: 24 hours post delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: No
Related trials for Myoma
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
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Prescription of Letrozole for Uterine Myoma
Leiomyoma, Uterine, Leiomyoma
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Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
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Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruiting
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
Uterine Fibroids (Leiomyoma), Uterine Myoma
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.
hany f allam, md principal investigator
Aswan University 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 Topical TA and vasopressin in people with Myoma, run by Aswan University 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 8 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 13 May 2019. 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 hany f allam, md (0102236052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure will be Mean amount of blood loss (time frame: intraoperative). 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 13 May 2019.