Reducing Blood Loss During Cesarean Myomectomy With Tranexamic Acid

NCT03505502 | Completed

• 1 other identifier: aswu/203/2/18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Conditions

Cesarean Section Complications

Keywords

Cesarean Myomectomy; Tranexamic Acid

Outcome Measures

Primary Outcomes (1)

• 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

  intraoperative

Secondary Outcomes (3)

• need for blood transfusion

  24 hours postoperative

• Hemoglobin concentration

  ist 24 hours postoperative

• operative time

  operative time

Study Arms (3)

placebo arm

PLACEBO COMPARATOR

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

Drug: IV tranexamic acid

IV tranexamic acid group

EXPERIMENTAL

group received IV tranexamic 1gm in normal saline

Drug: IV tranexamic acid

topical tranexamic acid group

ACTIVE COMPARATOR

group received topical tranexamic 2gm in normal saline

Drug: IV tranexamic acid

Interventions

IV tranexamic acid DRUG

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.

Also known as: Topical tranexamic acid

IV tranexamic acid group; placebo arm; topical tranexamic acid group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: 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
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (2)

AswanUH

Aswān, 81528, Egypt

Location

AswanUH

Aswān, Egypt

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: a double-blinded randomized placebo-controlled trial

Study Record Dates

• First Submitted: April 7, 2018
• First Posted: April 23, 2018
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)