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

NCT ID: NCT07315646

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-18
• Study Completion Date: 2027-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The TAS (transabominal ultrasound) insertion technique

This new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings.

Group Type: EXPERIMENTAL

IUS (intrauterine system) insertion

Intervention Type: PROCEDURE

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

The Traditional Technique

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.

Group Type: ACTIVE_COMPARATOR

IUS (intrauterine system) insertion

Intervention Type: PROCEDURE

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

Interventions

IUS (intrauterine system) insertion

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Imelda Hospital, Bonheiden

OTHER

Sponsor Role: collaborator

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Weyers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Central Contacts

Margot Van Geyte, MD

Role: CONTACT

margot.vangeyte@uzgent.be

+329323044

Study team Gynaecology & Obstetrics UZ Gent

Role: CONTACT

studieco.vrouwenkliniek@uzgent.be

+32 9 332 48 72

Other Identifiers

ONZ-2025-0220

Identifier Type: -

Identifier Source: org_study_id