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NCT04339348 Clinical Trial

Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion

Contraception Clinical Trial

Official title:
Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Reducing Pain During Levonorgestrel IUD Insertion in Women Delivered Only by Cesarean Deliveries

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04339348
Other study ID # misoprostol vs LP cream
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 30, 2020
Est. completion date March 1, 2021

Study information
Verified date May 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date March 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion Exclusion Criteria: - women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• vaginal misoprostol
vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus inert placebo cream vaginally at the time of LNG-IUD insertion
• Lidocaine-Prilocaine Topical cream
Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion
• placebo
inert placebo cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

Locations
Country Name City State
Egypt Ahmedsamy Giza

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary pain during LNG-IUD insertion pain during LNG-IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst imaginable pain 5 minutes
Secondary duration of insertion duration of LNG-IUD insertion from speculum in to speculum out 5 minutes
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