Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to IUD Insertion

Официальное название

Use of Cervical Cap and Menstrual Disc for Application of Topical Anesthetic Prior to Intrauterine Device (IUD) Insertion

Обзор

This prospective, open label, double arm, feasibility group study will recruit participants planning to undergo office intrauterine device (IUD) placement without sedation or anxiolysis at the Center for Women's Health. Participants will self-administer a topical anesthetic using a contraceptive cervical cap or menstrual disc. Twenty-four nulliparous women will be recruited to receive one of two administration methods immediately prior to IUD placement (12 subjects in each arm): 1) menstrual disc filled with 5g eutectic mixture of local anesthetics (EMLA) cream or 2) cervical cap filled with 5g EMLA cream.

Подробное описание

Nulliparous patients undergoing IUD insertion will administer EMLA cream by menstrual disc or cervical cap prior to insertion. The medical provider will ensure proper placement of the cap or disc and perform a bi-manual exam to assess the patient's uterine position. A seven minute timer will be set, the cap/disc will be removed, and the provider will proceed with the IUD insertion according to manufacturer technique.

Visual Analog Scale (VAS) scores will be used throughout the procedure to assess participant pain throughout insertion. Participants and providers will report on pain, side effects, and procedure complications immediately after the procedure.

Вмешательства

• Комбинированный продукт Menstrual disc with EMLA cream
  Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc
• Комбинированный продукт Cervical cap with EMLA cream
  Eutectic mixture of local anesthetics (EMLA) cream self-administered using a menstrual disc

Первичные конечные точки

• Successful Placement [Срок оценки: Immediately after IUD placement procedure]
• Satisfaction with pain control [Срок оценки: Immediately after IUD placement procedure]

Вторичные конечные точки (7)

• Ease of cap/disc placement [Срок оценки: Immediately after IUD placement procedure]
• Protocol deviations [Срок оценки: Immediately after IUD placement procedure]
• Ease of IUD placement [Срок оценки: Immediately after IUD placement procedure]
• Procedure complications [Срок оценки: Immediately after IUD placement procedure]
• Typical menstrual pain [Срок оценки: On the day of IUD placement procedure prior to cap/disc placement and IUD placement]
• Pain during IUD placement procedure [Срок оценки: Measured throughout IUD placement procedure immediately before the procedure, during placement of disc/cap, during speculum placement, during tenaculum placement, during sounding, during IUD placement, and 5 minutes after completion]
• Acceptability of pain mangement [Срок оценки: one day post-procedure]

Критерии участия

Критерии включения

• Scheduled for IUD placement at the Center for Women's Health in Complex Family Planning clinic
• Able to review and sign study consents in English
• Generally healthy

Критерии исключения

• History of any prior births, miscarriages, or abortions after 16 weeks' gestation
• Currently pregnant, known or suspected
• Current stringless IUD in place
• Participants premedicated with misoprostol
• History of chronic pelvic pain which patients take daily medication for
• History of endometriosis, fibroids, adenomyosis, prior cervical procedures (such as Loop Electrosurgical Excision Procedure (LEEP) or cold knife cone)
• Any contraindications to IUD placement (per current labeling including pregnancy, fibroids that distort the uterine cavity, exam consistent with pelvic inflammatory disease, allergy to any component of the levonorgestrel intrauterine system (LNG-IUS), etc.)
• Known allergy to eutectic mixture of local anesthetics (EMLA) or lidocaine cream, silicone, menstrual disc, or cervical cap
• Any contraindication to EMLA or lidocaine cream, menstrual disc, or cervical cap
• Previous IUD placement or failed attempt of an IUD placement
• Weight < 54.4kg (120 lbs)
• Plan for use of oral anxiolysis, moderate/deep sedation, or narcotics for procedure
• Patient requesting or patient use in the past 24 hours of oral anxiolysis, moderate/deep sedation, or narcotics
• Any planned concomitant procedures, such as dilation and curettage (D\&C), endometrial biopsy, colposcopy, hysteroscopy, etc.
• Illicit drug use

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

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Oregon Health & Science University — Portland

Идентификаторы

NCT: NCT06891794 · OHSU IRB 28118

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗