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CompletedNCT03308643Updated May 21, 2018

Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

A Phase 4 interventional study of Oxytocin and saline in Myomectomy, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

To evaluate the effects of oxytocin infusion during abdominal myomectomy.

Read the 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.

02

Conditions studied

  • Myomectomy

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Keywords

  • myomectomy
  • oxytocin
  • blood loss
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-50
  • Patients who are candidate for abdominal myomectomy

Exclusion criteria

Exclusion Criteria:

  • History of previous myomectomy.
  • Suspected malignancy
  • Patients with preoperative anemia
  • Patients using hormonal treatments before the surgery.
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Oxytocin infusion

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

    Drug: Oxytocin

  • 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

Interventions

  • DrugOxytocin

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

  • Othersaline

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

05

What researchers measure

Primary outcomes

  1. Blood loss during surgery

    estimated blood loss during the surgery measured by aspiration fluid.

    Time frame: 2 hours

Secondary outcomes

  1. Blood loss after abdominal myomectomy

    change in Hematocrit Percentage (before and after the surgery)

    Time frame: 1 hour postoperatively

06

Study locations

1 site
  • Kanuni Sultan Suleyman Egitim ve Arastırma Hastanesi
    İstanbul, Turkey
07

References and documents

Publications

  • 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. PubMed 27862855 ↗
  • 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. PubMed 16398771 ↗
08

Registry details

Key details

Study ID
NCT03308643
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Berna Aslan Cetin (Attending physician,ObGyn, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Oct 12, 2017
Start date
Oct 1, 2017
Primary completion
May 10, 2018
Completion
May 10, 2018
Last update
May 21, 2018

Study contacts

Berna Aslan
study director · Kanuni Sultan Suleyman Research and Training Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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