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

Primary Purpose

Cesarean Section Complications

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
IV tranexamic acid
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications focused on measuring Cesarean Myomectomy, Tranexamic Acid

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • AswanUH
  • AswanUH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

placebo arm

IV tranexamic acid group

topical tranexamic acid group

Arm Description

group receive i/v saline plus irrigation of the myoma bed with normal saline

group received IV tranexamic 1gm in normal saline

group received topical tranexamic 2gm in normal saline

Outcomes

Primary Outcome Measures

estimation of intraoperative blood loss (ml).
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

need for blood transfusion
need for blood transfusion
Hemoglobin concentration
pre and postoperative hemoglobin estimation
operative time
operative time

Full Information

First Posted
April 7, 2018
Last Updated
March 18, 2020
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03505502
Brief Title
Reducing Blood Loss During Cesarean Myomectomy With Tranexamic Acid
Acronym
TA
Official Title
Reducing Blood Loss During Cesarean Myomectomy With Intravenous Versus Topical Tranexamic Acid: a Double-blinded Randomized Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section Complications
Keywords
Cesarean Myomectomy, Tranexamic Acid

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a double-blinded randomized placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo arm
Arm Type
Placebo Comparator
Arm Description
group receive i/v saline plus irrigation of the myoma bed with normal saline
Arm Title
IV tranexamic acid group
Arm Type
Experimental
Arm Description
group received IV tranexamic 1gm in normal saline
Arm Title
topical tranexamic acid group
Arm Type
Active Comparator
Arm Description
group received topical tranexamic 2gm in normal saline
Intervention Type
Drug
Intervention Name(s)
IV tranexamic acid
Other Intervention Name(s)
Topical tranexamic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
estimation of intraoperative blood loss (ml).
Description
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
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
need for blood transfusion
Description
need for blood transfusion
Time Frame
24 hours postoperative
Title
Hemoglobin concentration
Description
pre and postoperative hemoglobin estimation
Time Frame
ist 24 hours postoperative
Title
operative time
Description
operative time
Time Frame
operative time

10. Eligibility

Sex
Female
Gender Based
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
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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: Patients undergone vaginal or laparoscopic myomectomy. Patients received preoperative embolization or gonadotrophin releasing hormone analog. Cervical and broad ligament myoma. Patients with cardiac, hepatic, renal or thromboembolic disease patients had an allergy to tranexamic acid).
Facility Information:
Facility Name
AswanUH
City
Aswan
ZIP/Postal Code
81528
Country
Egypt
Facility Name
AswanUH
City
Aswan
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Blood Loss During Cesarean Myomectomy With Tranexamic Acid

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