Efficacy Study of Topical Application of Lidacaine Spray Prior to IUD Insertion
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study is to determine whether the topical use of lidocaine spray 10% on the cervix is an effective way to reduce pain during IUCD insertion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 21, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 21, 2011
December 1, 2011
5 months
December 13, 2011
December 20, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
VAS score of Pain
5 minutes from lidocaine spraying ( after application of tenaculum)
Study Arms (2)
lidocaine spray 10%
ACTIVE COMPARATORSaline
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age 18-45
- Speak Arabic or English
You may not qualify if:
- History of cervical surgery
- Known hypersensitivity to topical analgesics
- First trimester abortion or miscarriage in the previous six weeks
- Second trimester abortion or miscarriage in the previous 12 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain shams university hospital
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Obstetrics and Gynecology
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 21, 2011
Study Start
July 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
December 21, 2011
Record last verified: 2011-12