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NCT04357002 Clinical Trial

Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Abdominal Myomectomy

Myomectomy Clinical Trial

Official title:
Evaluating Safety and Efficacy of Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Reducing Intraoperative Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04357002
Other study ID # dinoprostone tranexamic acid
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date April 30, 2020
Est. completion date October 15, 2020

Study information
Verified date April 2020
Source Cairo University
Contact AHMED SAMY
Phone +201100681167
Email ahmedsamy8233@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 180
Est. completion date October 15, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- symptomatic fibroids candidate for abdominal myomectomy

Exclusion Criteria:

- patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• intravenous tranexamic acid
patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.
• vaginal dinoprostone
patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
• vaginal placebo
patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary intraoperative blood loss estimation of intraoperative blood loss in ml one hour
Secondary blood transfusion need for intraoperative or postoperative blood transfusion 24 hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04080375 - Preoperative Vaginal Dinoprostone Prior to Abdominal Myomectomy Phase 3
Completed NCT03634306 - Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy N/A
Completed NCT03308643 - Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy Phase 4
Recruiting NCT03363425 - Effect of Perioperative iv Dexmedetomidine vs. Lidocaine on Postoperative Pain, Analgesic Consumption and Recovery After Abdominal Gynaecological Surgery Phase 2/Phase 3
Not yet recruiting NCT04358965 - Tranexamic Acid Versus Vaginal Misoprostol in Abdominal Myomectomy Phase 4
Not yet recruiting NCT04357015 - Intravenous Tranexamic Acid Versus IV Carbetocin in Abdominal Myomectomy Phase 4
Completed NCT03250221 - Comparison of Robot-assisted Laparoscopic Myomectomy and Traditional Laparoscopic Myomectomy With Barbed Sutures
Completed NCT02741531 - The Effect of Partial Bladder Filling on Post-operative Time to Void in Minimally Invasive Gynecologic Procedures N/A
Completed NCT02049242 - Uterine Tourniquet at Open Myomectomy N/A
Completed NCT00978601 - Improved Recovery Using Multimodal Peri-operative Analgesia in Minimally Invasive Myomectomy N/A
Completed NCT03892668 - Intravenous Oxytocin Versus Tranexamic Acid in Reducing Blood Loss During Abdominal Myomectomy. Phase 4