Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

May 17, 2018 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
To evaluate the effects of oxytocin infusion during abdominal myomectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey
        • Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss during surgery
Time Frame: 2 hours
estimated blood loss during the surgery measured by aspiration fluid.
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss after abdominal myomectomy
Time Frame: 1 hour postoperatively
change in Hematocrit Percentage (before and after the surgery)
1 hour postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Study Director: Berna Aslan, Kanuni Sultan Süleyman Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

May 10, 2018

Study Completion (Actual)

May 10, 2018

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 11, 2017

First Posted (Actual)

October 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 17, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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