Mentaal welzijn en kwaliteit van leven na insertie van een LNG-IUD versus een Cu-IUD. Een prospectieve studie.

The number of women looking for long acting reversible contraception (LARC) is on the rise in the Netherlands. The rise in the number of IUDs can predominantly be ascribed to the growing popularity of the levonorgestrel IUD (LNG-IUD). The promise of a reduction in the monthly amount of blood loss in the absence of systemic effects seems to be the most important reason for women to prefer a LNG-IUD over e.g. oral contraceptives or a Copper-IUD (Cu-IUD). Shortly after the report of the Rutgers stichting, a large prospective study regarding the physiological responses to stress in women using the LNG-IUD was published. This study showed that despite the low daily dose of levonorgestrel release by the LNG-IUD significant effects on basal heart rate and the release of cortisol are observed, disproving the common assumption that the LNG-IUD has little to no systemic influence. Therefore, as well as other hormonal contraceptives, LNG-IUD might have an effect on mental wellbeing and quality of life. Cu-IUDs have been available for decades for women looking for LARC and offer a true hormone free alternative to the LNG-IUD. Most comparative studies between LNG-IUD and Cu-IUD so far have focussed on bleeding patterns, efficacy as well discontinuation rates. So far, little notice has been paid on comparison of mental health or quality of life. The objective of this prospective cohort study is therefore to compare the effects of LNG-IUD versus Cu-IUD (T-Safe or Multi-Safe) on mental well-being and quality of life. Secundary outcomes that will be analysed involve overall quality of life, bleeding pattern, satisfaction with their IUD, reasons for discontinuation, sexual functioning and unintended pregnancy at 3, 6 and 12 months.

The hypothesis of this study is that a difference in mental well-being can be observed after insertion of an LNG-IUD compared to Cu-IUD insertion.

The comparison with regard to the primary endpoint will be made prior to and at the time of IUD insertion and at three, six and twelve months after IUD insertion.

women willing to participate in the study are requested to answer a web-based questionnaire prior to the IUD insertion, on the day of insertion as well as three, six and twelve months after insertion. Questions regard mental well-being, quality of life, bleeding pattern, satisfaction with their IUD, reasons for discontinuation and unintended pregnancy.