Is two-dimensional ultrasound necessary six weeks after insertion of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) contraceptive?
Not Applicable
Completed
- Conditions
- Diagnostics of malposition and complaints in women with 52-mg LNG-IUSUrological and Genital Diseases
- Registration Number
- ISRCTN11725991
- Lead Sponsor
- Máxima Medisch Centrum
- Brief Summary
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36387294/ (added 07/11/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 500
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of malposition on 2DUS during routine investigation six weeks after insertion
- Secondary Outcome Measures
Name Time Method <br> Clinical symptoms at six weeks:<br> 1. Unacceptable bleeding pattern measured using a questionnaire<br> 2. Pelvic pain measured using a 5-point Likert scale<br>