MyomectomyPhase 4NCT03892668
Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy.
A Phase 4 study testing Tranexamic Acid and oxytocin in people with Myomectomy, run by Cairo University at 1 site in Egypt.
Trial summary
Uterine leiomyomas (fibroids) are the most common benign tumors among women. Fibroids are found in approximately 20% of women over 35 years of age. In 20-50% of patients, fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Myomectomy
- What is being tested?
- Tranexamic Acid and oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2019to 15 Mar 2020
- Phase
- Phase 4
- 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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Age group (18-50) years old
- Intramural or interstitial myomas (more than 5 cm)
- Symptomatic myomas (heavy menstrual bleeding or pain during menstruation)
- Abdominal myomectomy
- No medical disorders
- No coagulation disorders
Who cannot join
- • Age group (less than 18 yrs old)
- Age group (more than 50 yrs old)
- Subserous or submucous myomas
- Laparoscopic or hysteroscopic myomectomy
- Medical disorders (for example uncontrolled hypertension, diabetes mellitus, renal or hepatic disorders)
- Coagulation disorders
Show all 12Show fewer
- Previous use of anticoagulant drugs
- Previous myomectomy
- Allergy to Tranexamic acid or oxytocin
- Malignant features by U/S or examination
- Pregnancy
- Previous hormonal therapy (GnRH analogues)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy; A Randomized Controlled Trial
Uterine leiomyomas (fibroids) are the most common benign tumors among women. Fibroids are found in approximately 20% of women over 35 years of age. In 20-50% of patients, fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract. Surgery is indicated for symptomatic uterine leiomyomas; hysterectomy for women who have completed childbearing (women > 40 years old), and myomectomy for women <40 years old who wish to preserve uterus and fertility.
Read the detailed description
Interventions:
Preoperative
- Full history, where demographic characteristics will be reported and examination to detect the size and mobility of uterus.
- Informed consent will be taken from patients.
- Trans-vaginal U/S to assess number, size, and types of myomas.
- Preoperative full labs (Hemoglobin, hematocrit, INR, liver enzymes and kidney functions)
Intra Operative
- Preoperative antibiotics will be given before the beginning of the operation. The operations will be performed as standard through a midline or Pfannenstiel incision by the same consultant gynecologist to ensure consistency of study procedures. All patients will receive general anesthesia. After the skin incision, the subcutaneous fat and abdominal fascia will be opened crosswise, and the rectus muscle will be opened on the midline. The parietal peritoneum will be opened longitudinally to reach the pelvic cavity. Subsequently, a self-retaining retractor will be inserted, and intestine will be packed. The uterus will be inspected for the number, location, and shape of myomas. Other pelvic organs will be inspected for any associated pathology. When possible, uterine incisions will be performed on the anterior wall or fundus in order to reduce postoperative adhesions. The incision will be performed using monopolar diathermy. Intracapsular enucleation of myomas will be performed by gently dissecting between the myoma and the pseudo-capsule. The myoma will be gently enucleated out. Meticulous hemostasis will be secured by low-voltage coagulation of feeding vessels. Myoma bed will be closed by 1 or 2 layers of interrupted vicryl sutures (Vicryl 1-0 polyglactin 910; Egycryl, Taisier CO, Egypt). No mechanical tourniquet or local vasoocclusive drugs (e.g., vasopressin) will be used intraoperatively.
- The study will include patients scheduled for open abdominal myomectomy and will be divided into three equal groups.
- All the three groups will take a standard dose of 400 microgram of misoprostol rectally one hour before the operation.
Postoperative
- Estimation of Hemoglobin 6 hrs postoperatively and next day morning.
- Monitor Vital Signs and need for blood transfusion.
- Send myomas for pathology.
- Conditions
- Myomectomy
- Being tested
- Tranexamic Acid, oxytocin, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Patients in the TXA group will be given 15 mg/kg of tranexamic acid (Cyklokapron@; Amoun Pharmaceutical Co., SAE) slowly intravenously 30 min before surgery followed by 10 mg/ kg/h infusion in 500 ml Ringer's by infusion pump till the end of the procedure.
oxytocinDrug
An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the OXYtocin group 30 min before surgery and will be followed by one ampoule of oxytocin (10 U/mL/amp) (Syntocinon; Aventis Pharmaceutical Co.) will be added to 500 mL Ringer's solution running at a rate of 400 mU/min by infusion pump till the end of the procedure.
placeboDrug
An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the Oxytocin group 30 min before surgery and will be followed by 500 ml saline infusion during the operation
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid | Experimental | Patients in the TXA group will be given 15 mg/kg of tranexamic acid (Cyklokapron@; Amoun Pharmaceutical Co., SAE) slowly intravenously 30 min before surgery followed by 10 mg/ kg/h infusion in 500 ml Ringer's by infusion pump till the end of the procedure. Receives: Drug: Tranexamic Acid |
| oxytocin | Active comparator | An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the OXYtocin group 30 min before surgery and will be followed by one ampoule of oxytocin (10 U/mL/amp) (Syntocinon; Aventis Pharmaceutical Co.) will be added to 500 mL Ringer's solution running at a rate of 400 mU/min by infusion pump till the end of the procedure. Receives: Drug: oxytocin |
| placebo | Placebo comparator | An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the oxytocin group 30 min before surgery and will be followed by 500 ml saline infusion during the operation Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood loss
The total volume of intraoperative blood loss was estimated by measuring the amount of blood accumulated in the aspiration equipment and the amount of blood on the surgical gauze using an alkaline hematin technique
Measured: during the operation
Secondary outcomes (2)
Operation time
Operation time from skin incision to skin closure in minutes.
Measured: 1 hour
Myomectomy time
Myomectomy time from first uterine incision to closure of last uterine incision in minutes
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start30 Apr 2019
- Primary completion1 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomectomyStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- AHMED SAMY, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892668
- Sponsor's protocol ID
- myomectomy
- Status last verified
- Apr 2020
- First submitted
- 26 Mar 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03892668
- Acronym / sponsor ID
- myomectomy
- Conditions
- Myomectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 27 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.
Uterine leiomyomas (fibroids) are the most common benign tumors among women. Fibroids are found in approximately 20% of women over 35 years of age. In 20-50% of patients, fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract. Surgery is indicated for symptomatic uterine leiomyomas; hysterectomy for women who have completed childbearing (women > 40 years old), and myomectomy for women <40 years old who wish to preserve uterus and fertility.
Detailed description
Interventions:
Preoperative
- Full history, where demographic characteristics will be reported and examination to detect the size and mobility of uterus.
- Informed consent will be taken from patients.
- Trans-vaginal U/S to assess number, size, and types of myomas.
- Preoperative full labs (Hemoglobin, hematocrit, INR, liver enzymes and kidney functions)
Intra Operative
- Preoperative antibiotics will be given before the beginning of the operation. The operations will be performed as standard through a midline or Pfannenstiel incision by the same consultant gynecologist to ensure consistency of study procedures. All patients will receive general anesthesia. After the skin incision, the subcutaneous fat and abdominal fascia will be opened crosswise, and the rectus muscle will be opened on the midline. The parietal peritoneum will be opened longitudinally to reach the pelvic cavity. Subsequently, a self-retaining retractor will be inserted, and intestine will be packed. The uterus will be inspected for the number, location, and shape of myomas. Other pelvic organs will be inspected for any associated pathology. When possible, uterine incisions will be performed on the anterior wall or fundus in order to reduce postoperative adhesions. The incision will be performed using monopolar diathermy. Intracapsular enucleation of myomas will be performed by gently dissecting between the myoma and the pseudo-capsule. The myoma will be gently enucleated out. Meticulous hemostasis will be secured by low-voltage coagulation of feeding vessels. Myoma bed will be closed by 1 or 2 layers of interrupted vicryl sutures (Vicryl 1-0 polyglactin 910; Egycryl, Taisier CO, Egypt). No mechanical tourniquet or local vasoocclusive drugs (e.g., vasopressin) will be used intraoperatively.
- The study will include patients scheduled for open abdominal myomectomy and will be divided into three equal groups.
- All the three groups will take a standard dose of 400 microgram of misoprostol rectally one hour before the operation.
Postoperative
- Estimation of Hemoglobin 6 hrs postoperatively and next day morning.
- Monitor Vital Signs and need for blood transfusion.
- Send myomas for pathology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid | Experimental | Drug: Tranexamic AcidPatients in the TXA group will be given 15 mg/kg of tranexamic acid (Cyklokapron@; Amoun Pharmaceutical Co., SAE) slowly intravenously 30 min before surgery followed by 10 mg/ kg/h infusion in 500 ml Ringer's by infusion pump till the end of the procedure. |
| oxytocin | Active comparator | Drug: oxytocinAn equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the OXYtocin group 30 min before surgery and will be followed by one ampoule of oxytocin (10 U/mL/amp) (Syntocinon; Aventis Pharmaceutical Co.) will be added to 500 mL Ringer's solution running at a rate of 400 mU/min by infusion pump till the end of the procedure. |
| placebo | Placebo comparator | Drug: placeboAn equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the oxytocin group 30 min before surgery and will be followed by 500 ml saline infusion during the operation |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Age group (18-50) years old
Key exclusion criteria (12 listed)
- • Age group (less than 18 yrs old)
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 AcidPatients in the TXA group will be given 15 mg/kg of tranexamic acid (Cyklokapron@; Amoun Pharmaceutical Co., SAE) slowly intravenously 30 min before surgery followed by 10 mg/ kg/h infusion in 500 ml Ringer's by infusion pump till the end of the procedure. | Drug | tranexamic acid |
| oxytocinAn equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the OXYtocin group 30 min before surgery and will be followed by one ampoule of oxytocin (10 U/mL/amp) (Syntocinon; Aventis Pharmaceutical Co.) will be added to 500 mL Ringer's solution running at a rate of 400 mU/min by infusion pump till the end of the procedure. | Drug | oxytocin |
| placeboAn equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the Oxytocin group 30 min before surgery and will be followed by 500 ml saline infusion during the operation | Drug | placebo |
Primary outcome
Intraoperative Blood loss
Time frame: during the operation
The total volume of intraoperative blood loss was estimated by measuring the amount of blood accumulated in the aspiration equipment and the amount of blood on the surgical gauze using an alkaline hematin technique
2 secondary outcomes
Operation time
Time frame: 1 hour
Myomectomy time
Time frame: 30 minutes
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 28 Apr 2020.
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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.
AHMED SAMY, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid and oxytocin in people with Myomectomy, run by Cairo 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 6 inclusion and 12 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 28 Apr 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Blood loss (time frame: during the operation). 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 28 Apr 2020.