Effect of Oxytocin Infusion on Blood Loss During Abdominal Myomectomy

NCT03308643 | Completed Phase 4

• 1 other identifier: 2016/3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effects of oxytocin infusion during abdominal myomectomy.

Conditions

Myomectomy

Keywords

myomectomy; oxytocin; blood loss

Outcome Measures

Primary Outcomes (1)

• Blood loss during surgery

  estimated blood loss during the surgery measured by aspiration fluid.

  2 hours

Secondary Outcomes (1)

• Blood loss after abdominal myomectomy

  1 hour postoperatively

Study Arms (2)

Oxytocin infusion

EXPERIMENTAL

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

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

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

Oxytocin DRUG

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

Oxytocin infusion

saline OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female patients with uterus and undergoing abdominal myomectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Egitim ve Arastırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27862855 RESULT

• 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.

  PMID: 16398771 RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Berna Aslan

  Kanuni Sultan Suleyman Research and Training Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician,ObGyn

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

Study Record Dates

• First Submitted: October 9, 2017
• First Posted: October 12, 2017
• Study Start: October 1, 2017
• Primary Completion: May 10, 2018
• Study Completion: May 10, 2018
• Last Updated: May 21, 2018

Record last verified: 2018-05

Locations

TU (1)