RCT: LNG-IUS insertion during menstruation compared with random insertion beyond menstruations in patient-perceived pain.
Recruiting
- Conditions
- anticonceptie/contraceptionMirena/LNG-IUSinsertionpain
- Registration Number
- NL-OMON23626
- Lead Sponsor
- Dr. M.Y. Bongers, gynaecologist Máxima Medisch Centrum VeldhovenDe Run 4600, 5504 DB Veldhovene-mail: M.Bongers@mmc.nl Phone (office): +31 40 8888384
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Women who menstruate with a wish for LNG-IUS.
Exclusion Criteria
•Women with an abnormal uterine cavity (myomas, polyps) determined by a TransVaginalUltrasound (TVU)
•Women with a failed insertion in a previous attempt either bij general practitioner or other Gyneacologist
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient-perceived pain during insertion of LNG-IUS using the Visual Analogue Scale (VAS)
- Secondary Outcome Measures
Name Time Method The secondary outcome will be easiness of insertion by the health care provider, scaled as easy or difficult (scored as difficult whenever advanced tools were necessary to use for a successful insertion, for example cervical dilatation or hysteroscopy) and short-term outcomes, i.e. patient satisfaction with LNG- IUS (scaled using the Likert scale ), removal rate, expulsion rate and pregnancy rate, and bleeding pattern during a follow-up of three months. After 3 months a 2D and 3D ultrasound will be made to check for expulsion and pregnancy rates.