Clinical trial · Interventional
Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy
Hemostatic Effect of Intrauterine Instillation of Oxytocin in Hysteroscopic Myomectomy: A Randomized Double Blinded Control 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)
There is no previous study on the hemostatic effect of intrauterine instillation of oxytocin in hysteroscopic myomectomy. All previous studies focused on intravenous administration of oxytocin. This trial may modify the surgical environment in hysteroscopic myomectomy by decreasing intraoperative bleeding to a degree that the amount of distention medium required for uterine distention will be reduced with a better visibility and shorter operation time. The standard treatment of symptomatic myomas is hysterectomy for women who have completed childbearing period, and myomectomy for women who wish to preserve fertility hysteroscopic myomectomy currently is the gold standard minimally invasive procedure for the management of symptomatic submucous fibroids. Success of hysteroscopic myomectomy depends on good visualization throughout the procedure, via the correct distending pressure, continuous irrigation and the use of electrosurgery to control bleeding. Prolonged procedures that need continuous irrigation under high pressure are associated with higher risk of excessive fluid absorption and intravasation syndrome due to opened blood vessels within the myometrial, moreover, the thermal damage of the healthy tissues is increased with the use of the coagulation current. Oxytocin receptors exist in the non-pregnant uterus but the concentration of the receptors is much lower than in pregnancy. this is why the clinical use of oxytocin outside of pregnancy is limited Oxytocin acts on oxytocin receptors in the myometrium and fibroid tissue leading to uterine contraction and constriction of uterine vasculature due to uterine contraction and vaso-constrictive effect of oxytocin thus reducing uterine perfusion and results in reducing intraoperative bleeding.
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 |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxytocin | Drug | — | UNRESOLVED |
| sterile bacteriostatic water ampule | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A (Oxytocin group):
- description
- 30 women will undergo a hysteroscopic myomectomy with the use of 10 IU of oxytocin for every 1000 ml of the distending medium (1,5% Glycine ).
- interventionNames
- Drug: Oxytocin
- type
- PLACEBO_COMPARATOR
- label
- Group B (Placebo group):
- description
- 30 women will undergo hysteroscopic myomectomy with the use of a sterile bacteriostatic water ampule in the distending medium (1,5% glycine).
- interventionNames
- Other: sterile bacteriostatic water ampule
Primary outcomes (2)
- measure
- the change in hemoglobin level 24 hours after the procedure surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Symptomatic patient (Menorrhagia, recurrent pregnancy loss or infertility). 2. 1 or 2 submucous uterine myoma diagnosed by ultrasound with a diameter less than 4 cm 3. Myoma with FIGO 0 or 1. 4. Body mass index less than 35. Exclusion Criteria: 1. Pregnancy 2. Active pelvic infection 3. history of bleeding disorder or patient on anti-coagulant. 4. hepatic and renal diseases. 5. history of ischemic heart disease. 6. Patients with uterine structural abnormality or uterine septum. 7. Present or history of cervical or uterine cancer. 8. Preoperative administration of gonadotropin-releasing hormone analogues or danazol. 9. Allergy to glycine. 10. Patients with hypercoagulopathy.
References
Publications (5)
- BACKGROUNDDi Spiezio Sardo A, Mazzon I, Bramante S, Bettocchi S, Bifulco G, Guida M, Nappi C. Hysteroscopic myomectomy: a comprehensive review of surgical techniques. Hum Reprod Update. 2008 Mar-Apr;14(2):101-19. doi: 10.1093/humupd/dmm041. Epub 2007 Dec 6. PMID 18063608
- BACKGROUNDVilos GA, Allaire C, Laberge PY, Leyland N; SPECIAL CONTRIBUTORS. The management of uterine leiomyomas. J Obstet Gynaecol Can. 2015 Feb;37(2):157-178. doi: 10.1016/S1701-2163(15)30338-8. PMID 25767949
- BACKGROUNDMunro MG, Critchley HO, Broder MS, Fraser IS; FIGO Working Group on Menstrual Disorders. FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age. Int J Gynaecol Obstet. 2011 Apr;113(1):3-13. doi: 10.1016/j.ijgo.2010.11.011. Epub 2011 Feb 22. PMID 21345435
- BACKGROUNDMaggi M, Magini A, Fiscella A, Giannini S, Fantoni G, Toffoletti F, Massi G, Serio M. Sex steroid modulation of neurohypophysial hormone receptors in human nonpregnant myometrium. J Clin Endocrinol Metab. 1992 Feb;74(2):385-92. doi: 10.1210/jcem.74.2.1309835. PMID 1309835
- BACKGROUNDAtashkhoei S, Fakhari S, Pourfathi H, Bilehjani E, Garabaghi PM, Asiaei A. Effect of oxytocin infusion on reducing the blood loss during abdominal myomectomy: a double-blind randomised controlled trial. BJOG. 2017 Jan;124(2):292-298. doi: 10.1111/1471-0528.14416. Epub 2016 Nov 15. PMID 27862855