Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy

February 1, 2026 updated by: ahmed nagy shaker ramadan, Cairo University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Uterine leiomyomas are the most common benign tumors of the female reproductive tract and frequently require surgical management when symptomatic. Abdominal myomectomy remains the standard fertility-preserving surgical option for women with large or multiple intramyometrial fibroids. However, excessive intraoperative and postoperative blood loss continues to be a major challenge during myomectomy and is associated with increased morbidity, blood transfusion requirements, prolonged hospitalization, and delayed recovery.

Several pharmacological and surgical strategies have been investigated to minimize blood loss during myomectomy, including mechanical tourniquets, vasoconstrictors, uterine artery occlusion, and uterotonic agents. Among uterotonics, methylergometrine maleate and carbetocin are well-established agents that induce sustained uterine contractions and may reduce bleeding by compressing uterine vasculature. Methylergometrine, an ergot alkaloid, has long been used in obstetric hemorrhage, while carbetocin, a long-acting oxytocin analogue, offers prolonged uterotonic activity with a favorable pharmacokinetic profile. Despite their individual use, comparative data on their intramyometrial administration during abdominal myomectomy remain limited.

This prospective, double-blind, randomized comparative clinical trial is designed to evaluate and compare the effectiveness of intramyometrial methylergometrine versus intramyometrial carbetocin in reducing blood loss during and after abdominal myomectomy. The study will be conducted at Fayoum University maternity hospitals over an anticipated period of 20 months. To minimize bias, all procedures will be performed by the same surgical team following a standardized operative technique.

Participants will be randomly allocated to one of two intervention arms. In the first arm, methylergometrine maleate diluted in saline will be injected intramyometrially around the myoma before uterine incision. In the second arm, carbetocin diluted in saline will be administered in the same intramyometrial manner. The injections will be given circumferentially around the myoma, approximately 1-2 cm from its margins, and repeated as needed according to the number of myomas. Allocation concealment will be ensured using sequentially numbered opaque sealed envelopes, and double blinding will be maintained by coding the study drugs, with the allocation key retained by a designated supervisor until study completion.

A standardized abdominal myomectomy technique will be used in all cases, including Pfannenstiel incision, careful enucleation of myomas, meticulous hemostasis, layered uterine closure, and routine use of intraperitoneal drainage. Intraoperative blood loss will be quantified using a gravimetric method combined with suction measurements, while postoperative blood loss will be assessed via drain output. Perioperative monitoring will include vital signs, laboratory investigations, and clinical assessment for adverse events.

Safety monitoring will focus on drug-related side effects, hemodynamic changes, thromboembolic manifestations, and postoperative complications. The need for intraoperative or postoperative blood transfusion will be determined according to predefined clinical and laboratory criteria. Participants will be followed postoperatively until discharge and reassessed during early follow-up to ensure recovery and detect delayed complications.

The findings of this study are expected to provide evidence-based guidance on the optimal intramyometrial uterotonic agent for reducing blood loss during abdominal myomectomy, thereby improving surgical safety and patient outcomes in gynecologic practice.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Faiyum Governorate
      • Al Fayyum, Faiyum Governorate, Egypt, 38521

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intramyometrial Ergometrine Injection
Participants receive intramyometrial injection of methylergometrine maleate diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy.
Drug: Methylergometrine (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.
Other Names:
  • Ergometrine
  • Methergine
  • Methylergometrine maleate
Experimental: Intramyometrial Carbetocin Injection
Participants receive intramyometrial injection of carbetocin diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy.
Drug: Carbetocin (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.
Other Names:
  • Carbetocin
  • Long-acting oxytocin analogue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated Intraoperative and Postoperative Blood Loss
Time Frame: From the start of surgery until removal of the intraperitoneal drain (up to 48 hours postoperatively)
Total blood loss will be assessed as the sum of intraoperative and postoperative blood loss during abdominal myomectomy. Intraoperative blood loss will be estimated using a gravimetric method by weighing surgical swabs and measuring blood volume collected in suction devices. Postoperative blood loss will be measured as the volume collected in the intraperitoneal suction drain.
From the start of surgery until removal of the intraperitoneal drain (up to 48 hours postoperatively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Blood Transfusion
Time Frame: Intraoperative period and through postoperative day 2 (up to 48 hours after surgery)
The proportion of participants requiring intraoperative or postoperative blood transfusion will be recorded based on clinical condition and predefined laboratory criteria.
Intraoperative period and through postoperative day 2 (up to 48 hours after surgery)
Change in Postoperative Hemoglobin and Hematocrit Levels
Time Frame: Baseline (preoperative) and postoperative day 2 (≈48 hours after surgery)
Hemoglobin and hematocrit levels will be measured preoperatively and on the second postoperative day to assess perioperative blood loss and the development of postoperative anemia.
Baseline (preoperative) and postoperative day 2 (≈48 hours after surgery)
Incidence of Drug-Related Side Effects
Time Frame: Time Frame: From drug administration through postoperative day 2 or hospital discharge, whichever occurs first (up to 72 hours)
The occurrence of adverse effects potentially related to the study drugs, including nausea, vomiting, diarrhea, shivering, headache, and cardiovascular effects, will be monitored and recorded.
Time Frame: From drug administration through postoperative day 2 or hospital discharge, whichever occurs first (up to 72 hours)
Duration of Surgery
Time Frame: During the surgical procedure
The total operative time will be recorded from skin incision to skin closure to assess surgical efficiency.
During the surgical procedure
Postoperative Febrile Morbidity
Time Frame: From end of surgery through postoperative day 3 (up to 72 hours after surgery)
The incidence of postoperative fever will be recorded as an indicator of infection or other postoperative complications.
From end of surgery through postoperative day 3 (up to 72 hours after surgery)
Length of Postoperative Hospital Stay
Time Frame: From date of surgery to hospital discharge (up to 7 days)
The duration of hospital stay will be measured in days from the date of surgery until discharge.
From date of surgery to hospital discharge (up to 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Kafrelsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

January 17, 2026

First Submitted That Met QC Criteria

February 1, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 1, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fayoum-MD-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet determined whether de-identified individual participant data (IPD) will be shared. If sharing is approved, only de-identified IPD necessary to reproduce the primary analyses may be made available to qualified researchers, and results will also be reported in aggregate form in publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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