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Is two-dimensional ultrasound necessary six weeks after insertion of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) contraceptive?

Is two-dimensional ultrasound (2DUS) necessary six weeks after insertion of 52-mg LNG-IUS?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11725991
Enrollment
500
Registered
2021-09-07
Start date
2015-03-01
Completion date
Unknown
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostics of malposition and complaints in women with 52-mg LNG-IUS Urological and Genital Diseases

Interventions

Immediately after insertion of the LNG-IUS, the position of the LNG-IUS was assessed with the 2DUS by the resident, gynaecologist or physician assistant who performed the insertion. Six weeks after in

Sponsors

Máxima Medisch Centrum
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women who visited our clinic for the insertion of a 52mg LNG-IUS (Mirena®) for contraception or treatment of heavy menstrual bleeding 2. Over 18 years of age

Exclusion criteria

Exclusion criteria: 1. Presence of intracavitary polyps or fibroids on 2DUS prior to insertion 2. Unprotected intercourse one month prior to insertion if insertion took place outside menstruation 3. Women were excluded for analyses if no ultrasound was performed six weeks after insertion

Design outcomes

Primary

MeasureTime frame
Incidence of malposition on 2DUS during routine investigation six weeks after insertion

Secondary

MeasureTime frame
Clinical symptoms at six weeks: 1. Unacceptable bleeding pattern measured using a questionnaire 2. Pelvic pain measured using a 5-point Likert scale

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026