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.
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
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,.. )
Parallel
IUS (intrauterine system) insertion
Procedure/SurgeryIntra-uterine device insertion (technique based on randomization arm)
Pain during insertion of the IUS
Pain during insertion, reported by the subject on a Numeric Rating Scale (NRS scale) 0-10
Dislocation
Dislocation: non-fundal position (\> 3mm fundal distance postinsertion) in the uterine cavity (Y/N)
Expulsion
Expulsion of the IUS during the procedure (Y/N)
Failure of insertion
Failure of insertion (yes/no)
vagal symptoms
Vagal symptoms: paillor, sweating, syncope (yes/no)
Pain experience during 7 days after placement
Pain experience (average and worst pain) during 7 days after placement (NRS 0-10)
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University Hospital, Ghent
Lead sponsor
Imelda Hospital, Bonheiden
Collaborator
