NCT02878135

Completed

Fast Versus Slow Application of Vulsellum During Intrauterin...

Assiut University Source

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Other study identifiers

Sponsor study identifier

SLVOL

Study Type

interventional

Actual enrollment (reported)

200

Locations

1 country

Sites

1

Timeline

Study Start

October 2016

Actual (reported)

Primary Completion

May 2017

Actual (reported)

Study Completion

June 2017

Actual (reported)

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 200 participants
Study completion date: June 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
August 22, 2016
Actual (reported)
First Posted
August 25, 2016
Actual (reported)
Study Start
October 2016
Actual (reported)
Primary Completion
May 2017
Actual (reported)
Study Completion
June 2017
Actual (reported)

Last Updated: August 1, 2017
Status Verified: July 2017
Last Update Submitted: July 31, 2017

Conditions

Improving Quality of Life

Outcome Measures

Primary Outcomes (1)

mean Pain score with vulsellum placement
5 minutes

Study Arms (2)

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

fast applicationProcedure

fast vulsellum

slow applicationProcedure

slow vulsellum

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Women not taken analgesics or anxiolytics in the 24 hours prior insertion
Women not taken misoprostol prior to intrauterine device insertion

Sponsors & Collaborators

Assiut University
Otherlead

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Study Officials

Ahmed Abbas, MD
Assiut University
PRINCIPAL INVESTIGATOR

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Dr

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

October 2016

Actual (reported)

Women who will accept to participate in the study

You may not qualify if:

Any contraindication to intrauterine device placement

Contact the study team to confirm eligibility.

Primary Completion

May 2017

Actual (reported)

Study Completion

June 2017

Actual (reported)

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing: Will share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02878135
Data provider: ClinicalTrials.gov
Source updated: 2017-08-01
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:52 UTC

Locations

EG(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

fast vulsellum

slow vulsellum

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations