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Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion

RecruitingNAAges 18 Years - 60 YearsFemaleUniversity Hospital, Ghent
NCT07315646 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rationale: The 2019 Belgian Health Survey shows that the combined oral contraceptive pill is the most commonly used form of contraception. However, the Pearl index of Long-acting reversible contraceptive (LARC) methods is significantly better (perfect and typical use \<0.5) compared to the combined oral contraceptive pill (perfect use \<1.0, typical use 2-9). An IUS is an example of a LARC method. IUS insertion might be painful. Because of this, women may be reluctant to opt for an IUS. The traditional technique for an IUS insertion uses a speculum after which a Pozzi tenaculum is placed on the cervix so that the uterus is brought into the stretching position by means of traction. The cavum is then measured by a uterine sound. These actions and the use of these instruments can contribute to the pain experience during insertion. The new technique, transabdominal sonographic (TAS) insertio

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women between18 years and 60 years (at the time of signing the ICF) * Who wish to have an IUS (Kyleena/Mirena) for reasons of family planning, conservative treatment for abnormal uterine bleeding or as part of hormonal treatment for menopausal symptoms * Dutch-speaking subjects Exclusion Criteria: * History of difficult IUS placement * Known cervical stenosis * Asherman's syndrome * Standard contraindications to an IUS (eg breast cancer, recent deep vein thrombosis, anatomical uterine abnormalities, pregnancy, acute PID, cervicitis, vaginitis or any lower genital tract infection, cervical or endometrial malignancy, history of septic abortion or postpartum endometritis in the last 3 months,.. ) * Current pelvic inflammatory disease * Pregnancy * Trophoblastic disease * Known cervical or endometrial carcinoma * Patients who have the profession of midwife, nurse or doctor.
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What it tests

  • IUS (intrauterine system) insertion
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Where

1 site
Ghent University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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