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Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy

ConditionMyoma;Uterus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-48
SponsorCairo University

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Methylergometrine (Intramyometrial Injection)

    Drug

    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.

  • Carbetocin (Intramyometrial Injection)

    Drug

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intramyometrial Ergometrine InjectionActive comparator 1 intervention
Group B: Intramyometrial Carbetocin InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Estimated Intraoperative and Postoperative Blood Loss

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.

Time frame
From the start of surgery until removal of the intraperitoneal drain (up to 48 hours postoperatively)

Secondary outcomes

1

Need for Blood Transfusion

The proportion of participants requiring intraoperative or postoperative blood transfusion will be recorded based on clinical condition and predefined laboratory criteria.

Time frame
Intraoperative period and through postoperative day 2 (up to 48 hours after surgery)
2

Change in Postoperative Hemoglobin and Hematocrit Levels

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.

Time frame
Baseline (preoperative) and postoperative day 2 (≈48 hours after surgery)
3

Incidence of Drug-Related Side Effects

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
Time Frame: From drug administration through postoperative day 2 or hospital discharge, whichever occurs first (up to 72 hours)
4

Duration of Surgery

The total operative time will be recorded from skin incision to skin closure to assess surgical efficiency.

Time frame
During the surgical procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Kafrelsheikh University

Sponsor institution

Kafrelsheikh University

Collaborator

Source ClinicalTrials.gov
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