CompletedNot Applicable

The Analgesic Efficacy of Forced Coughing During Intrauterine Device Insertion

Egypt400 participantsStarted 2018-05-01

Plain-language summary

This was a randomized controlled trial of 400 women who attended the outpatient clinic of Menoufia University Hospital for copper IUD insertion. The women were randomly assigned to cough and control groups.The primary outcome measure was the level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).

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: * Non pregnant women (aged 18-45 years) requesting copper T380A IUD insertion for contraception. * No prior vaginal delivery or pregnancy termination beyond 12 weeks gestation (as patulous cervical os may affect VAS score). * Any previous deliveries had been by cesarean section. * Immediately postmenstrual or 1 week after pregnancy termination. * They were willing to complete the study questionnaires. * All women had to be alert, oriented, and cooperative to respond easily to VAS. Exclusion criteria were: * Current pregnancy. * Prior vaginal delivery. * History of cervical stenosis. * Current pelvic inflammatory disease. * Uterine anomalies. * Undiagnosed abnormal uterine bleeding. * Fibroids distorting the uterine cavity. * Patients using chronic NSAIDs or on chronic pain medication. We randomized participants in a 1:1 ratio to cough and control groups. A statistician not directly involved in the study prepared a computer generated randomization list and placed the allocation information in sequentially numbered sealed envelopes that were opened according to the attendance of the subjects after signing the informed consent

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

The level of pain experienced at different steps of IUD insertion measured by a visual analogue scale (VAS).

Timeframe: Up to 22 months

Trial details

NCT IDNCT04602897

SponsorMenoufia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-12

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