Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

NCT ID: NCT03308643

Last Updated: 2018-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-05-10

Brief Summary

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To evaluate the effects of oxytocin infusion during abdominal myomectomy.

Detailed Description

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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.

Conditions

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Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The abdominal myomectomy cases will be randomized into 2 separate groups in a parallel fashion using an online software at 1:1 ratio.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Oxytocin infusion

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

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

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

Interventions

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Oxytocin

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

Intervention Type DRUG

saline

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Berna Aslan Cetin

Attending physician,ObGyn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berna Aslan

Role: STUDY_DIRECTOR

Kanuni Sultan Suleyman Research and Training Hospital

Locations

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Kanuni Sultan Suleyman Egitim ve Arastırma Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 27862855 (View on PubMed)

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.

Reference Type RESULT
PMID: 16398771 (View on PubMed)

Other Identifiers

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2016/3

Identifier Type: -

Identifier Source: org_study_id

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