Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy

NCT07390864 | Recruiting DMC

• 1 other identifier: Fayoum-MD-2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Myoma;Uterus

Keywords

Ergometrine; Carbetocin; Blood Loss; Abdominal Myomectomy

Outcome Measures

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.

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

Secondary Outcomes (6)

• Need for Blood Transfusion

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

• Change in Postoperative Hemoglobin and Hematocrit Levels

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

• 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)

• Duration of Surgery

  During the surgical procedure

• Postoperative Febrile Morbidity

  From end of surgery through postoperative day 3 (up to 72 hours after surgery)

Study Arms (2)

Intramyometrial Ergometrine Injection

ACTIVE COMPARATOR

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)

Intramyometrial Carbetocin Injection

EXPERIMENTAL

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)

Interventions

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.

Also known as: Methylergometrine maleate, Ergometrine, Methergine

Intramyometrial Ergometrine Injection

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.

Also known as: Carbetocin, Long-acting oxytocin analogue

Intramyometrial Carbetocin Injection

Eligibility Criteria

• Age: 25 Years - 48 Years
• Gender Eligibility Details: This study is open to participants who self-identify as female, as the intervention is performed in individuals with a uterus undergoing abdominal myomectomy for uterine fibroids.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead
• Kafrelsheikh University: collaborator

Study Sites (1)

Fayoum University

Al Fayyum, Faiyum Governorate, 38521, Egypt

RECRUITING

Related Publications (10)

• Taher A, Farouk D, Mohamed Kotb MM, Ghamry NK, Kholaif K, A Mageed A Allah A, Ali AS, Osman OM, Nabil H, Islam Y, Bakry MS, Islam BA, Alalfy M, Nassar SA, Bosilah AH, Ghanem AA, Ali Rund NM, Refaat R, Abdel Wahed Ali HA, Bakry A, Ashour ASA, Nabil M, Zaki SS. Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial. Fertil Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16.

  PMID: 33461754 RESULT

• Gallos I, Williams H, Price M, Pickering K, Merriel A, Tobias A, Lissauer D, Gee H, Tuncalp O, Gyte G, Moorthy V, Roberts T, Deeks J, Hofmeyr J, Gulmezoglu M, Coomarasamy A. Uterotonic drugs to prevent postpartum haemorrhage: a network meta-analysis. Health Technol Assess. 2019 Feb;23(9):1-356. doi: 10.3310/hta23090.

  PMID: 30821683 RESULT

• Spencer SPE, Lowe SA. Ergometrine for postpartum hemorrhage and associated myocardial ischemia: Two case reports and a review of the literature. Clin Case Rep. 2019 Nov 6;7(12):2433-2442. doi: 10.1002/ccr3.2516. eCollection 2019 Dec.

  PMID: 31893076 RESULT

• Hickman LC, Kotlyar A, Shue S, Falcone T. Hemostatic Techniques for Myomectomy: An Evidence-Based Approach. J Minim Invasive Gynecol. 2016 May-Jun;23(4):497-504. doi: 10.1016/j.jmig.2016.01.026. Epub 2016 Mar 9.

  PMID: 26855249 RESULT

• Kim T, Purdy MP, Kendall-Rauchfuss L, Habermann EB, Bews KA, Glasgow AE, Khan Z. Myomectomy associated blood transfusion risk and morbidity after surgery. Fertil Steril. 2020 Jul;114(1):175-184. doi: 10.1016/j.fertnstert.2020.02.110. Epub 2020 Jun 10.

  PMID: 32532486 RESULT

• Donnez J, Taylor HS, Marcellin L, Dolmans MM. Uterine fibroid-related infertility: mechanisms and management. Fertil Steril. 2024 Jul;122(1):31-39. doi: 10.1016/j.fertnstert.2024.02.049. Epub 2024 Mar 5.

  PMID: 38453041 RESULT

• Uimari O, Subramaniam KS, Vollenhoven B, Tapmeier TT. Uterine Fibroids (Leiomyomata) and Heavy Menstrual Bleeding. Front Reprod Health. 2022 Mar 4;4:818243. doi: 10.3389/frph.2022.818243. eCollection 2022.

  PMID: 36303616 RESULT

• Eltoukhi HM, Modi MN, Weston M, Armstrong AY, Stewart EA. The health disparities of uterine fibroid tumors for African American women: a public health issue. Am J Obstet Gynecol. 2014 Mar;210(3):194-9. doi: 10.1016/j.ajog.2013.08.008. Epub 2013 Aug 11.

  PMID: 23942040 RESULT

• Ahmad A, Kumar M, Bhoi NR, Badruddeen, Akhtar J, Khan MI, Ajmal M, Ahmad M. Diagnosis and management of uterine fibroids: current trends and future strategies. J Basic Clin Physiol Pharmacol. 2023 Mar 30;34(3):291-310. doi: 10.1515/jbcpp-2022-0219. eCollection 2023 May 1.

  PMID: 36989026 RESULT

• Yang Q, Ciebiera M, Bariani MV, Ali M, Elkafas H, Boyer TG, Al-Hendy A. Comprehensive Review of Uterine Fibroids: Developmental Origin, Pathogenesis, and Treatment. Endocr Rev. 2022 Jul 13;43(4):678-719. doi: 10.1210/endrev/bnab039.

  PMID: 34741454 RESULT

MeSH Terms

Conditions

Myofibroma; Hemorrhage

Interventions

Methylergonovine; Ergonovine; carbetocin

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Ahmed E Abd eltawab, MD

CONTACT

+201091355562; aea11@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of obstetrics and gynecology

Model Details: 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

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: February 5, 2026
• Study Start: January 18, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

EG (1)