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

Study acronym: PAINLESS
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 18, 2025 to Feb 11, 2026
    v3
  2. Minor Eligibility criteria shortened, about 23 wordsv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07315646
Lead Sponsor University Hospital, Ghent
Collaborators: Imelda Hospital, Bonheiden
Conditions
(from sponsor)
Intra-uterine Device Placement
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov