Different Analgesics Prior to Intrauterine Device (IUD) Insertion: Is There Any Evidence?
1 other identifier
interventional
200
2 countries
2
Brief Summary
Different ways of reducing pain during IUD insertion have been explored. So a randomized study will be conducted to test their role
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2015
2 active sites
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, 2015
CompletedFirst Submitted
Initial submission to the registry
July 8, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 22, 2016
June 1, 2016
1.4 years
July 8, 2015
June 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
current pain level with IUD insertion and 15 minutes post procedure measured by the Visual Analogue Scale.
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range to across a continuum of values and can not easily to be directly measured. Subjects pain using a 10 point visual analogue scale (-+VAS, anchors: 0=non, 10 = worst imaginable). The participants were asked to mark their pre IUD insertion pain expectancies initially, then to mark their pain during different steps of IUD placement.
15 minutes
Study Arms (4)
lidocaine group
ACTIVE COMPARATORGroup A will receive 10 ml 1% lidocaine (Xylocaine 1%, Astra Zeneca, Egypt) Para cervical block prior to insertion of IUD (injection sites at cervix-vaginal junction typically at 4 ,8 O'clock), Then 3 minutes waiting period between the administration of the Para cervical block and IUD insertion,
misoprostol group
ACTIVE COMPARATORGroup B will receive 400 mcg oral misoprostol (Sigma, Egypt) prior to IUD insertion
non steroid group
ACTIVE COMPARATORGroup C will receive oral naproxen (Naprosyn, Syntax, Egypt) prior to IUD insertion
placebo group
PLACEBO COMPARATORgroup D will receive placebo tablets.
Interventions
Eligibility Criteria
You may qualify if:
- Patients are considered eligible if:
- they are alert oriented and co-operative to response to the visual analogue scale (VAS).
- They will sign the informed consent to participate in the clinical trial before entering the study.
- Willingness to be randomized and complete study questionnaires.
You may not qualify if:
- Participants are excluded from participation if they are ineligible for an IUD by accepted criteria of our institution such as:
- A lidocaine allergy
- Copper allergy
- Current cervicitis
- Pelvic inflammatory disease (PID) within 3 months
- Uterine anomalies
- Pain medication within 6 hours before insertion
- Misoprostol administration within 24 hour before insertion
- History of cervical surgery and contraindication to study medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Al Hayat National Hospitallead
- Menoufia Universitycollaborator
Study Sites (2)
Menoufia University
Shebin Elkom, Egypt
Alhayah national hospital
Abhā, Saudi Arabia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
July 8, 2015
First Posted
August 13, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
June 22, 2016
Record last verified: 2016-06