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Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women With Previous Cesarean Delivery

Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women With Previous Cesarean Delivery

Recruiting
18-45 years
Female
Phase N/A

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Overview

Insertion of copper IUDs is often associated with moderate pain, which may reduce acceptance and continuation rates. Factors such as nulliparity and absence of prior vaginal delivery are known to increase pain perception. Women who have delivered only by cesarean section represent a special subgroup because their cervix has not undergone vaginal dilation and cervical remodeling, making insertion technically more difficult and often more painful. This group has been underrepresented in prior analgesia trials, highlighting an important evidence gap.

Description

Insertion of copper IUDs is often associated with moderate pain, which may reduce acceptance and continuation rates. Factors such as nulliparity and absence of prior vaginal delivery are known to increase pain perception. Women who have delivered only by cesarean section represent a special subgroup because their cervix has not undergone vaginal dilation and cervical remodeling, making insertion technically more difficult and often more painful. This group has been underrepresented in prior analgesia trials, highlighting an important evidence gap.

Pharmacological interventions (NSAIDs, opioids, local anesthetics) have shown inconsistent results. A randomized controlled trial demonstrated that verbal analgesia, using calm voice, reassurance, and continuous communication, was as effective as tramadol for IUD insertion among nulliparous women. To date, no randomized study has specifically addressed women delivered only by cesarean section

Eligibility

Inclusion Criteria:

  • Women aged 18-45 years.
    • Desire for Copper T380A IUD.
    • Delivery history limited to cesarean section(s), no vaginal delivery

Exclusion Criteria:

  • o Current pelvic infection, cervicitis, or vaginitis.
    • Uterine anomalies or fibroids distorting the cavity.
    • Contraindication to copper IUD procedure, and use of any analgesic medication within the last 6-8 hours prior to insertion.
    • Pregnancy or suspected pregnancy.
    • Severe dysmenorrhea requiring narcotics

Study details
    Contraception

NCT07326007

Cairo University

1 February 2026

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