Verbal Analgesia During Copper IUD Insertion After Cesarean Delivery (NCT07326007) | Clinical Trial Compass
CompletedNot Applicable
Verbal Analgesia During Copper IUD Insertion After Cesarean Delivery
Egypt88 participantsStarted 2025-10-10
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged 18-45 years.
* Requesting Copper T380A intrauterine device insertion.
* Delivery history limited to cesarean section(s), with no prior vaginal delivery.
* Regular menstrual cycles.
* Eligible for Copper T380A IUD insertion according to World Health Organization medical eligibility criteria.
* Able to provide written informed consent.
Exclusion Criteria:
* Current pelvic infection, cervicitis, or vaginitis.
* Uterine anomalies or fibroids distorting the uterine cavity.
* Any contraindication to Copper T380A IUD insertion.
* Contraindication to ibuprofen.
* Use of analgesic medication within 6-8 hours before insertion.
* Pregnancy or suspected pregnancy.
* Severe dysmenorrhea requiring narcotic analgesia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity at IUD release
Timeframe: Immediately after IUD release in the uterine cavity, or immediately after the final attempted insertion step in failed cases.