NCT02878135

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

August 22, 2016

Last Update Submit

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

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
  • 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.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

Study Officials

  • Ahmed Abbas, MD

    Assiut University

    PRINCIPAL INVESTIGATOR

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 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will share

Locations

EG(1)