CompletedNot Applicable

A Comparative Study Evaluating Pain Experienced During Intrauterine Device Insertion in Women

France162 participantsStarted 2021-06-23

Plain-language summary

The intrauterine device (IUD) is a reversible contraceptive method with good efficacy and long-lasting action. One of the obstacles to IUD insertion, both for healthcare professionals and patients, is the fear of painful insertion. There is little data in the literature on the pain experienced by patients, and even less in relation to their parity. Several studies have been conducted and show that nulliparous women seemed to experience more intense pain compared to multiparous women (2.7 vs 1.9 p\<0.05)

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged 18 or older * Patients desiring intrauterine device (IUD) contraception. * Patients without contraindications to the desired IUD contraception (uterine malformation, pregnancy, undiagnosed vaginal bleeding, current STI, Wilson's disease, uterine cancer, uterine fibroids, current phlebitis, breast cancer, hormone-sensitive condition, etc.). * Patients agreeing to participate in the study. * Patients agreeing to be contacted at 6 months and 1 year. Exclusion Criteria: * Patients under 18 years of age. * Patients 25 years of age or younger who have not been screened for Chlamydia and Gonorrhea prior to IUD insertion. * Patients with a contraindication to IUD insertion. * Patients with risk factors for sexually transmitted infections. * Patients with comprehension difficulties and/or a language barrier. * Patients who object to participating in the study. * Intrauterine device insertion by a practitioner in training (first insertion).

What they're measuring

The main objective of the study is to assess whether there is a significant difference between the pain experienced by nulliparous and multiparous women during the insertion of an intrauterine device.

Timeframe: Day 1

Trial details

NCT IDNCT07437235

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-03-30