Fast Versus Slow Application of Vulsellum During Intraute... | NCT02878135

Studies
Fast Versus Slow Application of Vulsellum During Intrauterine Device Insertion

NCT02878135

Sponsor

Assiut University

Status

Completed

Last Update Posted

Aug 1, 2017Actual

Enrollment

200Actual

Phase

Not Applicable

Conditions

Improving Quality of Life

Interventions

fast application
slow application

Countries

Egypt

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

Jul 2017

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

Oct 2016Actual

Primary Completion Date

May 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Aug 22, 2016

First Submission Date that Met QC Criteria

Aug 22, 2016

First Posted Date

Aug 25, 2016Estimated

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

Jul 31, 2017

Last Update Posted Date

Aug 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fast vulsellum	Experimental	rapid ratchet of the vulsellum	Procedure: fast application
slow vulsellum	Active Comparator	Placement of the tenaculum over 7-10 seconds and not allowing the vulsellum to ratchet audibly.	Procedure: slow application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fast application	Procedure		fast vulsellum
slow application

Measure	Description	Time Frame
mean Pain score with vulsellum placement		5 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women not taken analgesics or anxiolytics in the 24 hours prior insertion
Women not taken misoprostol prior to intrauterine device insertion
Women who will accept to participate in the study

Exclusion Criteria:

Any contraindication to intrauterine device placement

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Abbas, MD	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided