Calm verbal guidance versus standard care for pain during copper T380A IUD insertion after cesarean delivery
Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women With Previous Cesarean Delivery: An Open-Label Randomized Controlled Trial
This test will see if calm, reassuring verbal guidance during copper T380A IUD insertion reduces pain for women whose only prior births were by cesarean.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT07326007 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial compares a standardized verbal analgesia script (calm, continuous reassurance and brief procedural cues) with the site's usual technique for copper T380A IUD insertion in women aged 18–45 who have had only cesarean deliveries. The trial targets a subgroup whose cervices have not undergone vaginal dilation and may experience greater insertion pain. Pain scores during the procedure will be recorded and compared between groups, and procedural feasibility and immediate adverse events will be monitored. The design builds on prior work showing verbal analgesia can match tramadol for IUD insertion in nulliparous women but specifically enrolls women with prior cesarean delivery only.
Who should consider this trial
Good fit: Women aged 18–45 who desire a Copper T380A IUD and whose obstetric history includes only cesarean delivery, without pregnancy, active pelvic infection, uterine anomalies, or recent analgesic use are ideal candidates.
Not a fit: Individuals with uterine anomalies or fibroids distorting the cavity, current pelvic infection or suspected pregnancy, recent analgesic use, or severe dysmenorrhea requiring narcotics are unlikely to qualify or benefit from the verbal analgesia intervention.
Why it matters
Potential benefit: If successful, this low-cost approach could reduce insertion pain, lower the need for analgesic drugs, and improve IUD acceptance and continuation.
How similar studies have performed: A prior randomized trial found verbal analgesia as effective as tramadol for IUD insertion in nulliparous women, but no randomized study has specifically tested this approach in women delivered only by cesarean.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Giza
- Al Gezeera Hospital — Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud Alalfy
- Email: mahmoudalalfy@ymail.com
- Phone: +201002611058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.