Oxytocin Infusion and Abdominal Myomectomy

NCT ID: NCT03702946

Last Updated: 2018-10-11

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

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-15

Study Completion Date

2018-01-15

Brief Summary

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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

Detailed Description

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Conditions

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Oxytocin and Abdominal Myomectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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study group

Group Type EXPERIMENTAL

oxytocin in abdominal myomectomy

Intervention Type OTHER

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

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Armed Forces Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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arshad khushdil

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pediatrics

Rawalpindi, Punjab Province, Pakistan

Site Status

Military Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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OXYTOCIN

Identifier Type: -

Identifier Source: org_study_id

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