Clinical Trial

Verbal Analgesia During Copper IUD Insertion After Cesarean Delivery

Completed
View on ClinicalTrials.gov →
Summary
This open-label, parallel-group randomized controlled trial evaluated whether structured verbal analgesia reduces pain during Copper T380A intrauterine device insertion compared with standardized neutral communication in women with previous cesarean delivery and no prior vaginal birth. Eligible women requesting Copper T380A insertion were randomized in a 1:1 ratio to receive either a structured supportive communication protocol or standardized neutral procedural communication during insertion. The primary outcome was pain intensity measured on a 0-10 numerical rating scale immediately after IUD release in the uterine cavity, with pain at the final attempted insertion step used for failed insertions.
Protocol Amendment History 4 changes
critical Trial completed 2026-06-11
critical Primary endpoint(s) modified 2026-06-11
notable Primary completion pushed: 2026-02-15 -> 2026-04-10 2026-06-11
minor Completion pushed: 2026-02-28 -> 2026-05-10 2026-06-11
Trial Details
NCT Number NCT07326007
Lead Sponsor Cairo University
Collaborators: Algazeera Hospital
Conditions Contraception
Enrollment 88 participants
Start Date 2025-10-10
Primary Completion 2026-04-10 (estimated)
Study Completion 2026-05-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-10