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Идёт набор NCT07315646

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

Без фазы С лечением Intra-uterine Device Placement

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: IUS (intrauterine system) insertion.
Кому может быть актуально
Состояния в реестре: Intra-uterine Device Placement. Базовые параметры: 18 лет — 60 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
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Официальное название

The PAINLESS Study: Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion

Обзор

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) insertion, could reduce the pain experience during insertion. This new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings. Little high quality studies have been conducted on the advantages and disadvantages of the TAS technique as demonstrated by a non-published systematic review of the literature. Research question/goal: Is the insertion of an IUS (Kyleena/Mirena) using the TAS technique less painful than the traditional technique? Study design: A randomized trial (RCT) in which the subject is blinded to the insertion technique. Study population: Women wishing an IUS (Kyleena \& Mirena) Primary and secondary outcomes: The primary outcomes are the pain during insertion (Numeric Rating Scale (NRS) score 0-10) and dislocation: non-fundal position (\> 3mm fundal distance postinsertion) in the uterine cavity (Y/N). Secondary outcomes include the average and worst pain in the first week after insertion (NRS 0-10), expulsion of the IUS, perforation of the uterine wall, failure of insertion, the occurrence of vagal symptoms, use of pain relief the first 7 days after placement, subject satisfaction about the procedure, successful IUS placement.

Вмешательства

  • Процедура IUS (intrauterine system) insertion
    Intra-uterine device insertion (technique based on randomization arm)

Первичные конечные точки

  • Pain during insertion of the IUS [Срок оценки: From enrollment to the intervention date (IUS placement)]
  • Dislocation [Срок оценки: From enrollment to intervention date (IUS placement)]
Вторичные конечные точки (8)
  • Expulsion [Срок оценки: During of directly after the intervention (IUS placement)]
  • Failure of insertion [Срок оценки: During the procedure of IUS placement]
  • vagal symptoms [Срок оценки: During IUD insertion]
  • Pain experience during 7 days after placement [Срок оценки: During the 7 days after IUS insertion]
  • Pain relief taken during the 7 days after IUS placement [Срок оценки: During the 7 days after IUS placement]
  • Satisfaction with the procedure [Срок оценки: Seven days after IUS placement]
  • Successful IUS placement [Срок оценки: Directly after IUS insertion procedure]
  • Perforation [Срок оценки: During IUS placement]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Бельгия · 1 центр
  • Ghent University Hospital — Ghent

Идентификаторы

NCT: NCT07315646 · ONZ-2025-0220

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗