Myoma;Uterus
Conditions
Keywords
Ergometrine, Carbetocin, Blood Loss, Abdominal Myomectomy
Brief summary
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
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.
Interventions
DRUGMethylergometrine (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.
DRUGCarbetocin (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.
Sponsors
Cairo University
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
This study is designed as a parallel-group interventional clinical trial. Eligible participants undergoing abdominal myomectomy will be randomly assigned in a 1:1 allocation ratio to one of two intervention arms. Each participant will receive only one study intervention, and no crossover between treatment arms will occur during the study period. The parallel design allows for a direct comparison between intramyometrial methylergometrine and intramyometrial carbetocin, with both interventions administered at the same intraoperative time point and under identical surgical conditions. This model minimizes contamination between treatment arms and ensures that observed differences in blood loss and perioperative outcomes can be attributed to the assigned uterotonic agent. Randomization will be performed using a computer-generated randomization sequence, and allocation concealment will be maintained through the use of sequentially numbered opaque sealed envelopes. Double blinding will be i
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Intraoperative and Postoperative Blood Loss | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Blood Transfusion | 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. |
| Change in Postoperative Hemoglobin and Hematocrit Levels | 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. |
| Incidence of Drug-Related Side Effects | 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. |
| Duration of Surgery | During the surgical procedure | The total operative time will be recorded from skin incision to skin closure to assess surgical efficiency. |
| Postoperative Febrile Morbidity | 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. |
| Length of Postoperative Hospital Stay | 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. |
Countries
Egypt
Contacts
CONTACTAhmed E Abd eltawab, MD
Outcome results
None listed