Ergometrine versus carbetocin to reduce bleeding during abdominal myomectomy
Intramyometrial Ergometrine Injection Versus Intramyometrial Carbetocin Injection to Decrease Blood Loss During and After Abdominal Myomectomy: A Randomized Clinical Trial
This study will see if injecting ergometrine or carbetocin into the uterus during abdominal myomectomy reduces blood loss in women having surgery for symptomatic fibroids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 25 Years to 48 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Al Fayyum, Faiyum Governorate) |
| Trial ID | NCT07390864 on ClinicalTrials.gov |
What this trial studies
This is a prospective, double-blind, randomized comparison of intramyometrial methylergometrine (ergometrine) versus intramyometrial carbetocin given at the time of abdominal myomectomy. Women aged 25–48 with FIGO type 3–6 intramyometrial fibroids and BMI <35 scheduled for abdominal myomectomy are randomized to receive one of the two uterotonic injections. The trial measures intraoperative and postoperative blood loss, need for transfusion, and postoperative hemoglobin drop as key outcomes. The study is sponsored by Cairo University with sites including Fayoum University in Egypt.
Who should consider this trial
Good fit: Ideal candidates are women aged 25–48 with symptomatic intramyometrial fibroids (FIGO types 3–6), BMI under 35, and scheduled for abdominal myomectomy who can give informed consent.
Not a fit: Women with submucosal, pedunculated, cervical or adnexal fibroids (FIGO 0,1,2,7,8), recent hormonal treatment, prior uterine surgery, or contraindications to either drug are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the better drug could meaningfully reduce surgical blood loss, lower transfusion rates, and speed recovery after myomectomy.
How similar studies have performed: Both methylergometrine and carbetocin are established uterotonics used to reduce uterine bleeding in obstetrics and some myomectomy reports suggest benefit, but direct head-to-head intramyometrial comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Al Fayyum, Faiyum Governorate
- Fayoum University — Al Fayyum, Faiyum Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed E Abd eltawab, MD
- Email: aea11@fayoum.edu.eg
- Phone: +201091355562
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.