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Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

Primary Purpose

Myomectomy

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Oxytocin
saline
Sponsored by
Kanuni Sultan Suleyman Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myomectomy focused on measuring myomectomy, oxytocin, blood loss

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kanuni Sultan Suleyman Egitim ve Arastırma Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin infusion

Placebo

Arm Description

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

Patients will receive pure normal saline infusion at the same rate and volume just before the surgery after the induction of general anesthesia.

Outcomes

Primary Outcome Measures

Blood loss during surgery
estimated blood loss during the surgery measured by aspiration fluid.

Secondary Outcome Measures

Blood loss after abdominal myomectomy
change in Hematocrit Percentage (before and after the surgery)

Full Information

First Posted
October 9, 2017
Last Updated
May 17, 2018
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03308643
Brief Title
Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy
Official Title
Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
May 10, 2018 (Actual)
Study Completion Date
May 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effects of oxytocin infusion during abdominal myomectomy.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myomectomy
Keywords
myomectomy, oxytocin, blood loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
The abdominal myomectomy cases will be randomized into 2 separate groups in a parallel fashion using an online software at 1:1 ratio.
Masking
ParticipantInvestigator
Masking Description
Randomization will be performed by an online software and the list will be given to anesthesiologist so that neither the surgeon nor patient will know which intervention was performed. Randomized cards will be in sealed envelopes and will be open by anesthesiologist at the time of surgery.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin infusion
Arm Type
Experimental
Arm Description
Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive pure normal saline infusion at the same rate and volume just before the surgery after the induction of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
Patients will receive intravenous normal saline infusion just before the surgery after the induction of general anesthesia.
Primary Outcome Measure Information:
Title
Blood loss during surgery
Description
estimated blood loss during the surgery measured by aspiration fluid.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Blood loss after abdominal myomectomy
Description
change in Hematocrit Percentage (before and after the surgery)
Time Frame
1 hour postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients with uterus and undergoing abdominal myomectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berna Aslan
Organizational Affiliation
Kanuni Sultan Suleyman Research and Training Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Kanuni Sultan Suleyman Egitim ve Arastırma Hastanesi
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
27862855
Citation
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: 10.1111/1471-0528.14416. Epub 2016 Nov 15.
Results Reference
result
PubMed Identifier
16398771
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. doi: 10.1111/j.1471-0528.2005.00804.x.
Results Reference
result

Learn more about this trial

Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

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