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Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03308643
Recruitment Status : Completed
First Posted : October 12, 2017
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

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

Condition or disease Intervention/treatment Phase
Myomectomy Drug: Oxytocin Other: saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
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.
Primary Purpose: Prevention
Official Title: Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : May 10, 2018
Actual Study Completion Date : May 10, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin infusion
Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.
Drug: Oxytocin
Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.

Placebo Comparator: Placebo
Patients will receive pure normal saline infusion at the same rate and volume 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.




Primary Outcome Measures :
  1. Blood loss during surgery [ Time Frame: 2 hours ]
    estimated blood loss during the surgery measured by aspiration fluid.


Secondary Outcome Measures :
  1. Blood loss after abdominal myomectomy [ Time Frame: 1 hour postoperatively ]
    change in Hematocrit Percentage (before and after the surgery)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients with uterus and undergoing abdominal myomectomy
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308643


Locations
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Turkey
Kanuni Sultan Suleyman Egitim ve Arastırma Hastanesi
İstanbul, Turkey
Sponsors and Collaborators
Kanuni Sultan Suleyman Training and Research Hospital
Investigators
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Study Director: Berna Aslan Kanuni Sultan Suleyman Research and Training Hospital
Publications of Results:
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Responsible Party: Berna Aslan Cetin, Attending physician,ObGyn, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03308643    
Other Study ID Numbers: 2016/3
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital:
myomectomy
oxytocin
blood loss
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs