Efficacy of Intravenous Carbetocin Versus Tranexamic acid in Reducing Intraoperative Blood Loss During Myomectomy: A Double-blind, Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260626006

Enrollment

Registered

2026-06-26

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women with uterine Leiomyoma undergoing Myomectomy Uterine leiomyoma Myomectomy Carbetocin Tranexamic Acid Intraoperative blood Loss

Interventions

100 microgram of carbetocin diluted in 100 mL of normal saline will be administered by slow intravenous infusion over 10 minutes following the induction of general anesthesia,Tranexamic acid 1,000 mg

Experimental Drug,Active Comparator Drug

Carbetocin,Tranexamic

Eligibility

Sex/Gender

Female

Age

18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.Women diagnosed with uterine leiomyoma (FIGO types 0 to 7), with or without symptoms related to uterine fibroids. 2.Scheduled to undergo myomectomy, either by open myomectomy or laparoscopic myomectomy 3.Aged 18 to 50 years 4.Thai or non-Thai women who are able to understand and communicate effectively in the Thai language 5.Willing and able to provide written informed consent for participation in the study

Exclusion criteria

Exclusion criteria: 1.Pregnant women 2.History of previous myomectomy 3.Preoperative hemoglobin concentration <10 g/dL 4.Contraindications to carbetocin or tranexamic acid, including known hypersensitivity to either drug, cardiovascular disease, thromboembolic disorders, uncontrolled hypertension, epilepsy, or impaired hepatic or renal function. 5.Current use of herbal medications, aspirin, warfarin, or other anticoagulant and thrombolytic agents that may affect bleeding or coagulation.

Design outcomes

Primary

Measure	Time frame
Intraoperative blood loss from skin incision to end of operation volume of blood collected in suction canister and weight of all surgical sponges used during the procedure	—

Secondary

Measure	Time frame
Post operative hemoglobin 24 hours post operation complete blood count,post operative length of stay at hospital discharge number of days from the date of surgery to the date of hospital discharge as recorded in the patient medical record,operation time during surgery measured in minutes, from skin incision to completion of skin closure, as recorded in the operative report,Post operative blood transfusion requirement during hospitalization any blood transfusion administered after surgery during the index hospitalization	—

Measure

Time frame

Post operative hemoglobin 24 hours post operation complete blood count,post operative length of stay at hospital discharge number of days from the date of surgery to the date of hospital discharge as recorded in the patient medical record,operation time during surgery measured in minutes, from skin incision to completion of skin closure, as recorded in the operative report,Post operative blood transfusion requirement during hospitalization any blood transfusion administered after surgery during the index hospitalization

—

Countries

Thailand

Contacts

Public ContactNutcha Thiantanukij

Rajavithi hospital

thiannutcha97@gmail.com0921546946

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026