Actively Recruiting

Phase Not Applicable
Age: 25Years - 48Years
FEMALE
ID07390864

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

Led by Cairo University · Updated on 2026-02-05

40

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

C

Cairo University

Lead Sponsor

K

Kafrelsheikh University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial focuses on women aged 25 to 48 years with symptomatic uterine fibroids who are scheduled for abdominal myomectomy surgery. The study aims to compare two drugs, intramyometrial ergometrine and intramyometrial carbetocin, to see which one better reduces blood loss during and after surgery. Researchers also want to learn if there is a difference between these drugs in the need for blood transfusions and changes in hemoglobin levels postoperatively. Participants will be randomly assigned to receive either methylergometrine maleate or carbetocin injected around the fibroids directly into the uterus before the surgical incision. Both drugs are diluted in saline and administered circumferentially around the myoma. The surgical procedure includes a standardized abdominal myomectomy technique performed by the same surgical team to ensure consistent treatment. The study is double-blinded and uses concealed allocation to reduce bias. During the study, participants will be monitored for blood loss during and after surgery using gravimetric and suction methods, as well as drain output. Researchers will measure hemoglobin and hematocrit levels before and after surgery, track the need for blood transfusions, record drug-related side effects, and assess postoperative recovery including febrile morbidity and length of hospital stay. Safety monitoring will also focus on cardiovascular and thromboembolic effects. Follow-up will continue until hospital discharge and early postoperative recovery is confirmed.

CONDITIONS

Brief Title

Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy

Who Can Participate

Age: 25Years - 48Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female participants aged 25 to 48 years
  • Body mass index (BMI) less than 35 kg/m²
  • Symptomatic uterine fibroids requiring surgical management (such as abnormal bleeding, pelvic pain, or pressure)
  • Intramyometrial uterine myomas classified as FIGO types 3 to 6 confirmed by imaging
  • Largest myoma diameter 20 cm or less
  • Scheduled for abdominal myomectomy surgery
  • Able and willing to provide written informed consent
Not Eligible

You will not qualify if you...

  • Myomas of FIGO types 0, 1, 2, 7, or 8 (intracavitary, submucosal, pedunculated subserosal, cervical, or adnexal)
  • History of pelvic inflammatory disease, peritonitis, or significant abdominal or pelvic infection
  • Previous uterine surgery
  • Use of hormonal treatment within 3 months before enrollment
  • Contraindications to methylergometrine or carbetocin including drug allergy, hypertension, cardiac or lung disease, chronic endocrine or metabolic diseases, renal or liver impairment
  • High bleeding risk such as bleeding disorders, current antiplatelet or anticoagulant use, or preoperative anemia (hemoglobin below 10 g/dL)
  • Body mass index 35 kg/m² or higher
  • Conversion from myomectomy to hysterectomy during surgery

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery

Duration - Duration of the surgical procedure

Participants undergo abdominal myomectomy where they receive an intramyometrial injection of either methylergometrine or carbetocin around the myoma before uterine incision to reduce blood loss during surgery.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 7 days after surgery

Participants are monitored for blood loss, drug-related side effects, febrile morbidity, need for blood transfusion, and recovery until hospital discharge and during early follow-up visits.

Approximately 1 hospital stay and 1 follow-up visit

Trial Site Locations

Total: 1 location

1

Fayoum University

Al Fayyum, Faiyum Governorate, Egypt, 38521

Actively Recruiting

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Research Team

A

Ahmed E Abd eltawab, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial.

Ayman Taher, Dalia Farouk, Mohamed Mahmoud Mohamed Kotb...

https://pubmed.ncbi.nlm.nih.gov/33461754