RecruitingNot ApplicableNCT07390864

Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy

Intramyometrial Ergometrine Injection Versus Intramyometrial Carbetocin Injection to Decrease Blood Loss During and After Abdominal Myomectomy: A Randomized Clinical Trial


Sponsor

Cairo University

Enrollment

40 participants

Start Date

Jan 18, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized clinical trial is to determine whether intramyometrial ergometrine injection or intramyometrial carbetocin injection is more effective in reducing blood loss during and after abdominal myomectomy in women undergoing surgery for symptomatic uterine fibroids. The main questions it aims to answer are: Does intramyometrial ergometrine reduce intraoperative and postoperative blood loss during abdominal myomectomy? Does intramyometrial carbetocin reduce intraoperative and postoperative blood loss during abdominal myomectomy? Is there a difference between the two drugs in the need for blood transfusion and postoperative hemoglobin drop? Researchers will compare intramyometrial ergometrine injection with intramyometrial carbetocin injection to see which intervention is more effective in controlling surgical bleeding and improving surgical outcomes. Participants will: Undergo abdominal myomectomy for uterine fibroids Receive either intramyometrial ergometrine or intramyometrial carbetocin during surgery Be monitored for intraoperative blood loss, postoperative blood loss, hemoglobin changes, and need for blood transfusion


Eligibility

Sex: FEMALEMin Age: 25 YearsMax Age: 48 Years

Inclusion Criteria7

  • Female participants aged 25 to 48 years
  • Body mass index (BMI) \< 35 kg/m²
  • Symptomatic uterine fibroids requiring surgical management (e.g., abnormal uterine bleeding, pelvic pain, or pressure symptoms)
  • Intramyometrial uterine myomas classified as FIGO types 3 to 6, diagnosed by transvaginal ultrasonography or magnetic resonance imaging
  • Maximum diameter of the largest myoma ≤ 20 cm
  • Eligible for and scheduled to undergo abdominal myomectomy
  • Able and willing to provide written informed consent

Exclusion Criteria16

  • FIGO type 0, 1, 2, 7, or 8 myomas (intracavitary, submucosal, pedunculated subserosal, cervical, or adnexal)
  • History of pelvic inflammatory disease, peritonitis, or significant abdominal or pelvic infection
  • History of prior uterine surgery
  • Use of hormonal treatment within 3 months prior to enrollment
  • Contraindication to methylergometrine or carbetocin, including:
  • Known drug allergy
  • Hypertension
  • Cardiac or pulmonary disease
  • Chronic endocrine or metabolic disease (e.g., diabetes mellitus)
  • Renal or hepatic impairment
  • High risk of bleeding, including:
  • Known bleeding disorders
  • Current use of antiplatelet or anticoagulant therapy
  • Preoperative anemia (hemoglobin \< 10 g/dL)
  • BMI ≥ 35 kg/m²
  • Intraoperative conversion from myomectomy to hysterectomy

Interventions

DRUGMethylergometrine (Intramyometrial Injection)

Methylergometrine maleate is administered as an intramyometrial injection diluted in normal saline and injected circumferentially around the myoma before uterine incision during abdominal myomectomy to induce sustained uterine contraction and reduce surgical blood loss.

DRUGCarbetocin (Intramyometrial Injection)

Carbetocin is administered as an intramyometrial injection diluted in normal saline and injected circumferentially around the myoma before uterine incision during abdominal myomectomy to promote sustained uterine contraction and reduce intraoperative and postoperative blood loss.


Locations(1)

Fayoum University

Al Fayyum, Faiyum Governorate, Egypt

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NCT07390864


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