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

NCT07315646 | Not Yet Recruiting

• 1 other identifier: ONZ-2025-0220
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

intra-uterine device placement; TAS-technique; contraception use; uterine bleeding heavy; menopausal bleeding; family planning

Outcome Measures

Primary Outcomes (2)

• Pain during insertion of the IUS

  Pain during insertion, reported by the subject on a Numeric Rating Scale (NRS scale) 0-10

  From enrollment to the intervention date (IUS placement)

• Dislocation

  Dislocation: non-fundal position (\> 3mm fundal distance postinsertion) in the uterine cavity (Y/N)

  From enrollment to intervention date (IUS placement)

Secondary Outcomes (8)

• Expulsion

  During of directly after the intervention (IUS placement)

• Failure of insertion

  During the procedure of IUS placement

• vagal symptoms

  During IUD insertion

• Pain experience during 7 days after placement

  During the 7 days after IUS insertion

• Pain relief taken during the 7 days after IUS placement

  During the 7 days after IUS placement

Study Arms (2)

The TAS (transabominal ultrasound) insertion technique

EXPERIMENTAL

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

Procedure: IUS (intrauterine system) insertion

The Traditional Technique

ACTIVE COMPARATOR

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.

Procedure: IUS (intrauterine system) insertion

Interventions

IUS (intrauterine system) insertion PROCEDURE

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

The TAS (transabominal ultrasound) insertion technique; The Traditional Technique

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Imelda Hospital, Bonheiden: collaborator

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Steven Weyers, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margot Van Geyte, MD

CONTACT

+329323044; margot.vangeyte@uzgent.be

Study team Gynaecology & Obstetrics UZ Gent

CONTACT

+32 9 332 48 72; studieco.vrouwenkliniek@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 2, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share