Clinical trial · Interventional
Methods Decreasing Bleeding in Open Myomectomy
Comparing the Effectiveness of Misoprostol, Oxytocin, Carbetocin, Vasopressin, Bupivacaine and Epinephrine, Combined IV TXA Acid and Ethamsylate and Peri Cervical Tourniquet for the Reduction of Blood Loss During of Abdominal Myomectomy.
- 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)
Uterine leiomyomas (fibroids or myomas) are benign, smooth muscle tumors of the human uterus. Most myomas are asymptomatic (symptomless) and are discovered incidentally during a routine pelvic examination or imaging studies and have a lifetime incidence of approximately 70% in the general population . However, Approximately 20-40% of women with fibroids experience significant symptoms and consult gynecologic care. The most common clinical symptoms include abnormal uterine bleeding, dysmenorrhea, pelvic pain, infertility, and recurrent pregnancy loss The standard treatment of symptomatic leiomyomas is Abdominal myomectomy Blood loss during myomectomy can be intra-operative or postoperative and with hematoma formation. The average volume of blood loss during abdominal myomectomy is 200 to 800 ml. massive blood loss associated with the dissection of huge fibroids renders myomectomy a more technically challenging procedure than hysterectomy. Sometimes myomectomy is converted to hysterectomy intra-operatively when bleeding becomes heavy and uncontrollable or when it is impossible to reconstruct the uterus because of the many defects left by removal of multiple myomas . Many techniques are used to reduce blood loss during myomectomy; preoperative measures such as correction of preoperative anemia associated with menorrhagia may be treated with iron supplementation, use of gonadotropin (GHG) triggers prior to surgery. Intra-operative measures as use of tourniquet around the uterus during the operation, injections of Vasopressin or other vasopressors as epinephrine in the uterine muscle and use of ecbolic (misoprostol, oxytocin, and carbetocin etc.). Uterine artery ligation, embolization, or internal iliac artery ligation may also be used to avoid hysterectomy when heavy bleeding is anticipated or occurs during myomectomy
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Loss, Surgical | — | UNRESOLVED | — |
| Ethamsylate Allergy | — | UNRESOLVED | — |
| Misoprostol Allergy | — | UNRESOLVED | — |
| Myoma | Myoma | ONTOLOGY_EXACT | 0.98 |
| Oxytocin Allergy | — | UNRESOLVED | — |
| Tranexamic Acid Allergy | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bupivacaine Hydrochloride 0.5 % Injectable Solution epinephrine | Drug | — | UNRESOLVED |
| Carbetocin | Drug | — | UNRESOLVED |
| combined TXA and ethamsylate | Drug | — | UNRESOLVED |
| Misoprostol | Drug | — | UNRESOLVED |
| Oxytocin | Drug | — | UNRESOLVED |
| Tourniquet | Device | — | UNRESOLVED |
| Vasopressin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- ACTIVE_COMPARATOR
- label
- misoprostol
- description
- 15 patients will receive 800 microgram (tablet 200mcg X 4) misoprostol (Misotac 200 mcg, SIGMA pharmaceutical, Egypt) rectally one and half hour before operation.
- interventionNames
- Drug: Misoprostol
- type
- ACTIVE_COMPARATOR
- label
- Tourniquet
- description
- (15 patient): The operation will be performed with the use of Foleys catheter as an improvised tourniquet applied at the base of the uterus then infiltration myometrium overlying the leiomyoma with a solution composed of Bupivacaine Hcl 0.25% and 0.5 mg of epinephrine
- interventionNames
- Device: Tourniquet
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 48 Years
Show eligibility criteria text
Inclusion Criteria: 1. patients aged between 25 to 48 years old. 2. BMI less than 35 kg/m2 3. symptomatic uterine myomas.. 4. myoma staging from (3 to 6) according to FIGO staging through trans vaginal ultrasonography (TVUSG) or magnetic resonance imaging (MRI) according to FIGO classification. 5. Maximum diameter of the largest myoma is 15 cm. 6. Uterine size between 14 to 28 weeks pregnancy. Exclusion Criteria: 1. History of previous myomectomy 2. Allergy to Misoprostol, carbetocin, TXA, ethamsylate, Oxytocin, vasopressin, bupivacaine and epinephrine. 3. Hypertension. 4. Cardiac and Pulmonary diseases. 5. Patients who have bleeding disorders. 6. Patients on antiplatelets or anticoagulant before surgery. 7. Anemia (Hb \< 10g %). 8. Chronic endocrine or metabolic diseases such as Diabetes. 9. Renal and hepatic impairment. 10. Obesity (body mass index \> 30 kg/m2). 11. Cases that will require intraoperative conversion of myomectomy to hysterectomy. 12. Intracavitary, submucosal, pedunculated Subserosal and adnexal Myoma FIGO staging 0,1,2,7,8. 13. history of Gynecological infections (PID), history of abdominal infections e.g.: peritonitis, history of any abdominal or pelvic operation for non-obstetric cause.
References
Publications (10)
- BACKGROUNDCooper JM, Brady RM. Intraoperative and early postoperative complications of operative hysteroscopy. Obstet Gynecol Clin North Am. 2000 Jun;27(2):347-66. doi: 10.1016/s0889-8545(00)80026-1. PMID 10857125
- BACKGROUNDDonnez J, Dolmans MM. Uterine fibroid management: from the present to the future. Hum Reprod Update. 2016 Nov;22(6):665-686. doi: 10.1093/humupd/dmw023. Epub 2016 Jul 27. PMID 27466209
- BACKGROUNDKongnyuy EJ, Wiysonge CS. Interventions to reduce haemorrhage during myomectomy for fibroids. Cochrane Database Syst Rev. 2014 Aug 15;2014(8):CD005355. doi: 10.1002/14651858.CD005355.pub5. PMID 25125317
- BACKGROUNDKrentel H, De Wilde RL. Complications in Laparoscopic Supracervical Hysterectomy(LASH), especially the morcellation related. Best Pract Res Clin Obstet Gynaecol. 2016 Aug;35:44-50. doi: 10.1016/j.bpobgyn.2015.11.001. Epub 2015 Nov 14. PMID 26694587
- BACKGROUNDMohamed, S. E. S., Mansour, D. Y., & Shaker, A. N. (2019). The effect of misoprostol on intra-operative blood loss during myomectomy operation: Randomized controlled trial. Evidence Based Women's Health Journal, 9(1), 363-371.
- BACKGROUNDShady, N. W., Sallam, H. F., & Fahmy, H. (2018). Reducing blood loss during open myomectomy with intravenous versus topical tranexamic acid: A double-blinded randomized placebo-controlled trial. Middle East Fertility Society Journal, 23(3), 225-231.
- BACKGROUNDSirkeci RF, Belli AM, Manyonda IT. Treating symptomatic uterine fibroids with myomectomy: current practice and views of UK consultants. Gynecol Surg. 2017;14(1):11. doi: 10.1186/s10397-017-1014-4. Epub 2017 Jul 6. PMID 28890674
- BACKGROUNDSleiman Z, Baba RE, Garzon S, Khazaka A. The Significant Risk Factors of Intra-Operative Hemorrhage during Laparoscopic Myomectomy: A Systematic Review. Gynecol Minim Invasive Ther. 2019 Nov 11;9(1):6-12. doi: 10.4103/GMIT.GMIT_21_19. eCollection 2020 Jan-Mar.