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Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03166111
Collaborator
(none)
216
Enrollment
1
Location
2
Arms
33
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .

Condition or Disease Intervention/Treatment Phase
  • Drug: lidocaine gel
  • Drug: placebo gel
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Effect of Self-administered Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery: A Randomized Controlled Study
Actual Study Start Date :
Sep 1, 2017
Actual Primary Completion Date :
Mar 31, 2020
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: lidocaine group

lidocaine in-situ gel inserted vaginally

Drug: lidocaine gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
Placebo Comparator: placebo group

placebo gel inserted vaginally

Drug: placebo gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Outcome Measures

Primary Outcome Measures

  1. The difference in pain scores during intrauterine device insertion [10 minutes]

    using visual analog scale from 0 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Non-pregnant women

  • Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion

  • Women who delivered only by caesarean section

Exclusion criteria:

  • Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids

  • Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use

  • Allergy to lidocaine.

  • Women refuse to participate in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Mohamed Abbas, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03166111
Other Study ID Numbers:
  • LISITU
First Posted:
May 24, 2017
Last Update Posted:
Oct 6, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lidocaine

Study Results

No Results Posted as of Oct 6, 2020