NCT03702946

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

October 6, 2018

Last Update Submit

October 9, 2018

Conditions

Oxytocin and Abdominal Myomectomy

Outcome Measures

Primary Outcomes (1)

  • Intra-operative blood loss

    average intra operative blood loss was measured

    during the surgical procedure

Study Arms (2)

study group

EXPERIMENTAL
Other: oxytocin in abdominal myomectomy

control group

NO INTERVENTION

Interventions

oxytocin in abdominal myomectomyOTHER

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

study group

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women of ASA class I-II with intramural fibroids,
  • women planned to undergo elective abdominal myomectomy

You may not qualify if:

  • Women with hemoglobin (Hb) \< 10g/dl
  • Women with any respiratory or cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pediatrics

Rawalpindi, Punjab Province, 68000, Pakistan

Location

Military Hospital

Rawalpindi, Punjab Province, 68000, Pakistan

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

October 6, 2018

First Posted

October 11, 2018

Study Start

July 15, 2017

Primary Completion

January 15, 2018

Study Completion

January 15, 2018

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)