Ergometrine versus carbetocin to reduce bleeding during abdominal myomectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Fayoum University
  Al Fayyum, Faiyum Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Ahmed E Abd eltawab, MD
• Email: aea11@fayoum.edu.eg
• Phone: +201091355562

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventing adhesions after myomectomy surgery

  This study is testing whether a special gel used during myomectomy surgery can help prevent scar tissue from forming in women aged 18 to 45, which could improve their chances of getting pregnant later.

  Recruiting University Hospital, Ghent · Ghent · NCT05683041

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.