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Reducing Blood Loss During Cesarean Myomectomy With Tranexamic Acid (TA)

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ClinicalTrials.gov Identifier: NCT03505502
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
hany farouk, Aswan University Hospital

Brief Summary:
This study was a double-blinded randomized controlled study conducted at Aswan University, Egypt from January 2018 to January 2020. Study inclusion criteria were women who attended the outpatient obstetric clinic, seeking antenatal care diagnosed with leiomyomas with pregnancy and with myoma staging from (3 to 6) according to FIGO staging. scheduled to undergo cesarean myomectomy (11) Exclusion criteria were: 1-Patients undergone vaginal delivery.2-Patients with a history of thromboembolic disease. 3-Cervical and broad ligament myoma. 4-Myoma FIGO staging

Condition or disease Intervention/treatment Phase
Cesarean Section Complications Drug: IV tranexamic acid Not Applicable

Detailed Description:

Eligible participants were allocated to one of two groups after induction of anesthesia and immediately prior to the operation and just before skin incision. they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal salines) by slow intravenous injection at an approximate rate of 1 mL per min. The abdomen was exposed through a midline or Pfannenstiel incision, after skin incision, the subcutaneous fat and abdominal fascia were opened crosswise, and the rectus muscle was opened on the midline. The parietal peritoneum was opened longitudinally to reach the pelvic cavity. Uterus was inspected for a number, location, and shape of myomas and other pelvic organs were inspected for associated pathology. a lower uterine incision will be performed to deliver the baby and Uterine incisions on top of myoma were performed. The incision was performed using monopolar diathermy. Intracapsular enucleation of myomas was performed by gently dissecting between the myoma and the pseudo-capsule. The myoma was grasped by Collins forceps and gently enucleated out.,. Myoma bed was closed by 1 or 2 layers of interrupted vicryl sutures (Vicryl 1-0 polyglactin 910; Egycryl, Taisier CO, Egypt). At the end of the surgery, 1 intraperitoneal suction drain was routinely used in all patients the drains were removed on the second postoperative day unless otherwise indicated. Number and size of myomas were recorded. Myoma size represented the mean size of each myoma. Enucleated myomas were sent to histopathology.

Blood loss estimation Intraoperative blood loss was measured by adding the volume of the contents of the suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a double-blinded randomized placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients were randomized to three groups, each compromised of thirty-five patients according to a three-blocked randomization list which was coded (1 or 2 or 3) at 1:1:1 ratio. The three parallel groups were prepared using a Computer-generated randomization system. The allocated groups will be concealed in serially numbered sealed opaque envelopes that will only be opened after recruitment. The patient allocation will be performed prior to the induction of anesthesia by an independent person, who will not otherwise be involved in this study. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used.
Primary Purpose: Prevention
Official Title: Reducing Blood Loss During Cesarean Myomectomy With Intravenous Versus Topical Tranexamic Acid: a Double-blinded Randomized Placebo-controlled Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: placebo arm
group receive i/v saline plus irrigation of the myoma bed with normal saline
Drug: IV tranexamic acid
in IV tranexamic acid group they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min.In topical tranexamic acid groupA gauze soaked with 2g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.) used to compress the myoma bed for 5 minutes. To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moisten at least 1500 cm2.
Other Name: Topical tranexamic acid

Experimental: IV tranexamic acid group
group received IV tranexamic 1gm in normal saline
Drug: IV tranexamic acid
in IV tranexamic acid group they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min.In topical tranexamic acid groupA gauze soaked with 2g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.) used to compress the myoma bed for 5 minutes. To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moisten at least 1500 cm2.
Other Name: Topical tranexamic acid

Active Comparator: topical tranexamic acid group
group received topical tranexamic 2gm in normal saline
Drug: IV tranexamic acid
in IV tranexamic acid group they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min.In topical tranexamic acid groupA gauze soaked with 2g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.) used to compress the myoma bed for 5 minutes. To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moisten at least 1500 cm2.
Other Name: Topical tranexamic acid




Primary Outcome Measures :
  1. estimation of intraoperative blood loss (ml). [ Time Frame: intraoperative ]
    Intraoperative blood loss was measured suction bottle and the difference in weight (in grams) between the dry and the soaked operation sheets and towels (1 gram = 1 ml.). Post-operative blood loss was measured through intraperitoneal suction drain which measured every 12 hours and on removing the drain. After that, the total blood loss was calculated by the addition of intraoperative and postoperative blood loss.and vaginal bleeding


Secondary Outcome Measures :
  1. need for blood transfusion [ Time Frame: 24 hours postoperative ]
    need for blood transfusion

  2. Hemoglobin concentration [ Time Frame: ist 24 hours postoperative ]
    pre and postoperative hemoglobin estimation

  3. operative time [ Time Frame: operative time ]
    operative time



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women who attended the outpatient obstetric clinic, seeking antenatal care diagnosed with leiomyomas with pregnancy and with myoma staging from (3 to 6) according to FIGO staging. scheduled to undergo cesarean myomectomy
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women who attended the outpatient gynecology clinic, seeking treatment for symptomatic leiomyomas and scheduled to undergo abdominal myomectomy with myoma staging from (3 to 6) according to FIGO staging

Exclusion Criteria:

  1. Patients undergone vaginal or laparoscopic myomectomy.
  2. Patients received preoperative embolization or gonadotrophin releasing hormone analog.
  3. Cervical and broad ligament myoma.
  4. Patients with cardiac, hepatic, renal or thromboembolic disease
  5. patients had an allergy to tranexamic acid).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505502


Locations
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Egypt
AswanUH Recruiting
Aswan, Egypt, 81528
Contact: Hany F Sallam, md    00201022336052    hany.farouk@aswu.edu.eg   
Contact: Nahla w Shady, md    00101092440504    nahla.elsayed@aswu.ed.eg   
AswanUH Recruiting
Aswan, Egypt
Contact: hany F sallam, md    00201022336052 ext 002    hany.farouk@aswu.edu.eg   
Contact: Nahla W Shady, md    00201092440504 ext 002    Nahla.elsayed@aswu.edu.eg   
Sponsors and Collaborators
Aswan University Hospital

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Responsible Party: hany farouk, lecturer, Aswan University Hospital
ClinicalTrials.gov Identifier: NCT03505502     History of Changes
Other Study ID Numbers: aswu/203/2/18
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by hany farouk, Aswan University Hospital:
Cesarean Myomectomy
Tranexamic Acid

Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants