Mentaal welzijn en kwaliteit van leven na insertie van een LNG-IUD versus een Cu-IUD. Een prospectieve studie.
- Conditions
- Cu-IUDLNG-IUDMental well beingQuality of liveKoper spiraalMirena spiraalKyleena spiraalMentaal welzijnKwaliteit van leven
- Registration Number
- NL-OMON22570
- Lead Sponsor
- Titus Health Care
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 420
Inclusion Criteria
• Age; between 18 and 45 years
• Wish for LARC by means of a LNG-IUD or Cu-IUD for a minimum period of 12 months.
Exclusion Criteria
• Cu-IUD insertion as emergency contraception.
• Patients with heavy bleeding pattern/problems or with a wish for less blood-loss.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rimary endpoint of this prospective cohort study is to determine whether or not a difference in mental well-being can be observed between patients receiving an LNG-IUD versus an Cu-IUD. The comparison will be made prior to and at the time of IUD insertion and at three, six and twelve months after IUD insertion.
- Secondary Outcome Measures
Name Time Method Secondary outcomes that will be analysed involve overall quality of life, bleeding pattern, satisfaction with their IUD, reasons for discontinuation, sexual functioning and unintended pregnancy.