Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

Myomectomy Clinical Trial

Official title:

Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308643
• Other study ID #: 2016/3
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: May 10, 2018

Study information

• Verified date: May 2018
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of oxytocin infusion during abdominal myomectomy.

Description:

Myomectomy is indicated for symptomatic uterine fibroids. Fibroids have blood supply and 20% of the abdominal myomectomy cases might require blood transfusion because of the nature of the surgery. Oxytocin infusion is one of the intervention to decrease blood loss during myomectomy. To evaluate the effects and benefits of oxytocin infusion during abdominal myomectomy we decide to conduct this randomized study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 10, 2018
• Est. primary completion date: May 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age 18-50

• Patients who are candidate for abdominal myomectomy

Exclusion Criteria:

• History of previous myomectomy.

• Suspected malignancy

• Patients with preoperative anemia

• Patients using hormonal treatments before the surgery.

Related Conditions & MeSH terms

• Hemorrhage
• Myomectomy

Intervention

Drug:
• Oxytocin
Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.

Other:
• saline
Patients will receive intravenous normal saline infusion just before the surgery after the induction of general anesthesia.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Egitim ve Arastirma Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Atashkhoei 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: 10.1111/1471-052 — View Citation

Chang FW, Yu MH, Ku CH, Chen CH, Wu GJ, Liu JY. Effect of uterotonics on intra-operative blood loss during laparoscopy-assisted vaginal hysterectomy: a randomised controlled trial. BJOG. 2006 Jan;113(1):47-52. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss during surgery	estimated blood loss during the surgery measured by aspiration fluid.	2 hours
Secondary	Blood loss after abdominal myomectomy	change in Hematocrit Percentage (before and after the surgery)	1 hour postoperatively