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

NCT07315646 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-07

No results posted yet for this study

Summary

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.

Conditions

  • Intra-uterine Device Placement

Interventions

PROCEDURE

IUS (intrauterine system) insertion

Intra-uterine device insertion (technique based on randomization arm)

Sponsors & Collaborators

  • Imelda Hospital, Bonheiden

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Steven Weyers, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2026-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315646 on ClinicalTrials.gov