Oxytocin Infusion and Abdominal Myomectomy | NCT03702946

Studies
Oxytocin Infusion and Abdominal Myomectomy

NCT03702946

Sponsor

Armed Forces Hospital, Pakistan

Status

Completed

Last Update Posted

Oct 11, 2018Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Oxytocin and Abdominal Myomectomy

Interventions

oxytocin in abdominal myomectomy

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2017Actual

Primary Completion Date

Jan 15, 2018Actual

Completion Date

Jan 15, 2018Actual

First Submitted Date

Oct 6, 2018

First Submission Date that Met QC Criteria

Oct 9, 2018

First Posted Date

Oct 11, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2018

Last Update Posted Date

Oct 11, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

arshad khushdil, Assistant professor, Armed Forces Hospital, PakistanPrincipal Investigator

Lead Sponsor

Armed Forces Hospital, PakistanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental		Other: oxytocin in abdominal myomectomy
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oxytocin in abdominal myomectomy	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intra-operative blood loss	average intra operative blood loss was measured	during the surgical procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Pediatrics		Rawalpindi	Punjab Province	68000	Pakistan
Military Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010121	Oxytocin

Ancestor Terms

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

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Browse Branches

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