Oxytocin Infusion and Abdominal Myomectomy

Oxytocin and Abdominal Myomectomy Clinical Trial

Official title:

Effect of Oxytocin Infusion on Reducing the Blood Loss During Abdominal Myomectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702946
• Other study ID #: OXYTOCIN
• Status: Completed
• Phase: Phase 3
• Start date: July 15, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: October 2018
• Source: Armed Forces Hospital, Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective:To compare oxytocin infusion with control, in patients undergoing abdominal myomectomy in terms of mean blood loss.

Design: Single blinded randomized control trial Setting: Obstetrics and Gynecology Department, Military Hospital, Rawalpindi Population: 60 women of ASA class I-II, with intramural fibroids, candidate for elective abdominal myomectomy.

Methods: Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given.

Main outcome measure: Intra-operative blood loss

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

Inclusion Criteria:

1. women of ASA class I-II with intramural fibroids,

2. women planned to undergo elective abdominal myomectomy

Exclusion Criteria:

1. Women with hemoglobin (Hb) < 10g/dl

2. Women with any respiratory or cardiovascular disease.

Related Conditions & MeSH terms

• Oxytocin and Abdominal Myomectomy

Intervention

Other:
• oxytocin in abdominal myomectomy
Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given

Locations

Country	Name	City	State
Pakistan	Department of Pediatrics	Rawalpindi	Punjab
Pakistan	Military Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-operative blood loss	average intra operative blood loss was measured	during the surgical procedure