About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Methylergometrine (Intramyometrial Injection)
- Carbetocin (Intramyometrial Injection)
Treatment groups
Sponsors and collaborators
Cairo University
Lead sponsor
Kafrelsheikh University
Sponsor institution
Kafrelsheikh University
Collaborator