Clinical trial · Interventional
Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy
Intramyometrial Ergometrine Injection Versus Intramyometrial Carbetocin Injection to Decrease Blood Loss During and After Abdominal Myomectomy: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myoma;Uterus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbetocin (Intramyometrial Injection) | Drug | — | UNRESOLVED |
| Methylergometrine (Intramyometrial Injection) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intramyometrial Ergometrine Injection
- description
- Participants receive intramyometrial injection of methylergometrine maleate diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy.
- interventionNames
- Drug: Methylergometrine (Intramyometrial Injection)
- type
- EXPERIMENTAL
- label
- Intramyometrial Carbetocin Injection
- description
- Participants receive intramyometrial injection of carbetocin diluted in saline and administered circumferentially around the myoma before uterine incision during abdominal myomectomy.
- interventionNames
- Drug: Carbetocin (Intramyometrial Injection)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 48 Years
Show eligibility criteria text
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
References
Publications (10)
- RESULTTaher 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
- RESULTGallos 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
- RESULTSpencer 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
- RESULTHickman 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
- RESULTKim 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
- RESULTDonnez 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
- 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.